<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03027609</url>
  </required_header>
  <id_info>
    <org_study_id>AR-105-002</org_study_id>
    <nct_id>NCT03027609</nct_id>
  </id_info>
  <brief_title>Adjunctive Therapeutic Treatment With Human Monoclonal Antibody AR-105 (Aerucin®) in P. Aeruginosa Pneumonia</brief_title>
  <official_title>Placebo-controlled, Double-blind, Randomized Study of Aerucin® as Adjunct Therapy to Antibiotics in the Treatment of P. Aeruginosa Pneumonia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Aridis Pharmaceuticals, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Aridis Pharmaceuticals, Inc.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Prospective, double-blind, randomized assessment of the efficacy, safety and pharmacokinetic&#xD;
      of Aerucin® as adjunct treatment (in addition to standard of care antibiotics) for pneumonia&#xD;
      caused by P. aeruginosa.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a double-blind, randomized, placebo-controlled study of the human monoclonal antibody&#xD;
      (mAb) AR-105 for the adjunctive therapeutic treatment of P. aeruginosa pneumonia in&#xD;
      mechanically ventilated subjects. Subjects who are randomized will be treated with either&#xD;
      standard of care (SOC) antibiotics plus placebo or SOC antibiotics plus AR-105. The study is&#xD;
      being conducted at approximately 100 clinical sites across 17 countries. Subjects who meet&#xD;
      all of the inclusion criteria and none of the exclusion criteria are screened by the&#xD;
      microbiological culture test and/or rapid diagnostic test of an endotracheal aspirate to&#xD;
      confirm the presence of an active P. aeruginosa infection. Following eligibility&#xD;
      confirmation, the subject will be randomized in a 1:1 ratio to one of two treatment groups.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 29, 2017</start_date>
  <completion_date type="Actual">April 25, 2019</completion_date>
  <primary_completion_date type="Actual">April 25, 2019</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Clinical Cure on Day 21</measure>
    <time_frame>21 days following dosing</time_frame>
    <description>A summary of the number (%) of patients who were cured on or before Day 21 (micro-ITT population) is provided, by treatment group</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Clinical Cure on Day 7</measure>
    <time_frame>7 days following dosing</time_frame>
    <description>A summary of the number (%) of patients who were cured on or before Day 7 (micro-ITT population) is provided, by treatment group</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical Cure on Day 14</measure>
    <time_frame>14 days following dosing</time_frame>
    <description>A summary of the number (%) of patients who were cured on or before Day 14 (micro-ITT population) is provided by treatment group</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical Cure on Day 28</measure>
    <time_frame>28 days following dosing</time_frame>
    <description>A summary of the number (%) of patients who were cured on or before Day 28 (micro-ITT population) is provided by treatment group</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">158</enrollment>
  <condition>Pseudomonas Aeruginosa Pneumonia</condition>
  <arm_group>
    <arm_group_label>AR-105</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>One intravenous infusion of AR-105 20mg/'kg</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Matching placebo</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>AR-105</intervention_name>
    <description>monoclonal antibody</description>
    <arm_group_label>AR-105</arm_group_label>
    <other_name>Aerubumab</other_name>
    <other_name>Aerucin</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>matching placebo (+ SOC antibiotics)</description>
    <arm_group_label>Control</arm_group_label>
    <other_name>Control (SOC antibiotics)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Informed consent&#xD;
&#xD;
          -  ≥18 years of age, ≥ 20 years of age (Taiwan only),≥ 19 (S. Korea only)&#xD;
&#xD;
          -  pneumonia due to P. aeruginosa&#xD;
&#xD;
          -  mechanically-ventilated&#xD;
&#xD;
          -  intubated&#xD;
&#xD;
          -  APACHE II score between 10 and 35&#xD;
&#xD;
        Exclusion Criteria (main criteria):&#xD;
&#xD;
          -  being moribund&#xD;
&#xD;
          -  effective antibiotic therapy ≥48 hours&#xD;
&#xD;
          -  immunocompromised&#xD;
&#xD;
          -  underlying pulmonary disease that may preclude the assessment of a therapeutic&#xD;
             response&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Research Site 1</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95814</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site 2</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site 3</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32209</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site 4</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33606</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site 5</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site 6</name>
      <address>
        <city>Lexington</city>
        <state>Kentucky</state>
        <zip>40536</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site 7</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site 8</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site 9</name>
      <address>
        <city>Royal Oak</city>
        <state>Michigan</state>
        <zip>48073</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site 10</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63141</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Hackensack</city>
        <state>New Jersey</state>
        <zip>02601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Adelaide</city>
        <zip>5000</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Woolloongabba</city>
        <zip>QLD 4102</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Brest</city>
        <zip>224027</zip>
        <country>Belarus</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Gomel</city>
        <zip>246027</zip>
        <country>Belarus</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Grodno</city>
        <zip>230030</zip>
        <country>Belarus</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Minsk</city>
        <zip>220049</zip>
        <country>Belarus</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Minsk</city>
        <zip>223041</zip>
        <country>Belarus</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Vitebsk</city>
        <zip>210037</zip>
        <country>Belarus</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Brussels</city>
        <zip>1090</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Brussels</city>
        <zip>11070</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Brussels</city>
        <zip>1200</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Dinant</city>
        <zip>5500</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Liège</city>
        <zip>4000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Yvoir</city>
        <zip>5530</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Brno</city>
        <zip>65691</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Plzen</city>
        <zip>30460</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Praha</city>
        <zip>10034</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Praha</city>
        <zip>12808</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Praha</city>
        <zip>16902</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Teplice</city>
        <zip>41529</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Zlín</city>
        <zip>76275</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Angers</city>
        <zip>49933</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Argenteuil</city>
        <zip>95107</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Colombes</city>
        <zip>92701</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>La Roche-sur-Yon</city>
        <zip>85925</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Le Chesnay</city>
        <zip>78157</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Lille</city>
        <zip>59037</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Limoges</city>
        <zip>87042</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Lyon</city>
        <zip>69004</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Lyon</city>
        <zip>69677</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Nantes</city>
        <zip>44093</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site 1</name>
      <address>
        <city>Paris</city>
        <zip>75013</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site 2</name>
      <address>
        <city>Paris</city>
        <zip>75013</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Paris</city>
        <zip>75013</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Pierre-Bénite</city>
        <zip>69495</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Pontoise</city>
        <zip>95303</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Strasbourg</city>
        <zip>67091</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Tourcoing</city>
        <zip>59208</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Tours</city>
        <zip>37044</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site 1</name>
      <address>
        <city>Kutaisi</city>
        <zip>4600</zip>
        <country>Georgia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site 2</name>
      <address>
        <city>Kutaisi</city>
        <zip>4600</zip>
        <country>Georgia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Tbilisi</city>
        <zip>0144</zip>
        <country>Georgia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site 1</name>
      <address>
        <city>Athens</city>
        <zip>10676</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site 2</name>
      <address>
        <city>Athens</city>
        <zip>11527</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site 1</name>
      <address>
        <city>Larissa</city>
        <zip>41110</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site 2</name>
      <address>
        <city>Larissa</city>
        <zip>41221</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site 3</name>
      <address>
        <city>Budapest</city>
        <zip>1122</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site 2</name>
      <address>
        <city>Budapest</city>
        <zip>H-1082</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site 1</name>
      <address>
        <city>Budapest</city>
        <zip>H-1134</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Debrecen</city>
        <zip>H-4032</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Nyiregyhaza</city>
        <zip>H-4400</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site 1</name>
      <address>
        <city>Gyeonggi-do</city>
        <zip>425-707</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site 2</name>
      <address>
        <city>Gyeonggi-do</city>
        <zip>442-723</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site 2</name>
      <address>
        <city>Seoul</city>
        <zip>02841</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site 1</name>
      <address>
        <city>Seoul</city>
        <zip>03080</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site 3</name>
      <address>
        <city>Seoul</city>
        <zip>05505</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site 4</name>
      <address>
        <city>Seoul</city>
        <zip>07441</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Wŏnju</city>
        <zip>26426</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site 1</name>
      <address>
        <city>Guadalajara</city>
        <zip>44280</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site 2</name>
      <address>
        <city>Guadalajara</city>
        <zip>44760</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Monterrey</city>
        <zip>64460</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Lima</city>
        <zip>15072</zip>
        <country>Peru</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Miraflores</city>
        <zip>15074</zip>
        <country>Peru</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>San Martín De Porres</city>
        <zip>15102</zip>
        <country>Peru</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Opole</city>
        <zip>45-418</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Warsaw</city>
        <zip>02-781</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Krasnodar</city>
        <zip>350012</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Krasnoyarsk</city>
        <zip>660022</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site 2</name>
      <address>
        <city>Novosibirsk</city>
        <zip>119049</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site 3</name>
      <address>
        <city>Novosibirsk</city>
        <zip>630051</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site 1</name>
      <address>
        <city>Novosibirsk</city>
        <zip>630075</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site 2</name>
      <address>
        <city>Saint Petersburg</city>
        <zip>192242</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site 3</name>
      <address>
        <city>Saint Petersburg</city>
        <zip>196067</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site 4</name>
      <address>
        <city>Saint Petersburg</city>
        <zip>196247</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site 1</name>
      <address>
        <city>Saint Petersburg</city>
        <zip>197706</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Tomsk</city>
        <zip>634050</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site 1</name>
      <address>
        <city>Barcelona</city>
        <zip>08036</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site 2</name>
      <address>
        <city>Barcelona</city>
        <zip>08221</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site 3</name>
      <address>
        <city>Barcelona</city>
        <zip>08221</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site 4</name>
      <address>
        <city>Barcelona</city>
        <zip>0897</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Madrid</city>
        <zip>28040</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Mataró</city>
        <zip>08034</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Oviedo</city>
        <zip>33011</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Santander</city>
        <zip>39008</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Tarragona</city>
        <zip>43005</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site 1</name>
      <address>
        <city>Kaohsiung</city>
        <zip>80756</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site 2</name>
      <address>
        <city>Kaohsiung</city>
        <zip>81362</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site 2</name>
      <address>
        <city>Taichung</city>
        <zip>40447</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site 1</name>
      <address>
        <city>Taichung</city>
        <zip>40705</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Tainan</city>
        <zip>71004</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site 1</name>
      <address>
        <city>Taipei</city>
        <zip>10002 R.O.C</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site 4</name>
      <address>
        <city>Taipei</city>
        <zip>10449</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site 2</name>
      <address>
        <city>Taipei</city>
        <zip>11217</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site 3</name>
      <address>
        <city>Taipei</city>
        <zip>114</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Ivano-Frankivs'k</city>
        <zip>76008</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Kiev</city>
        <zip>01034</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Lviv</city>
        <zip>79059</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Belarus</country>
    <country>Belgium</country>
    <country>Czechia</country>
    <country>France</country>
    <country>Georgia</country>
    <country>Greece</country>
    <country>Hungary</country>
    <country>Korea, Republic of</country>
    <country>Mexico</country>
    <country>Peru</country>
    <country>Poland</country>
    <country>Russian Federation</country>
    <country>Spain</country>
    <country>Taiwan</country>
    <country>Ukraine</country>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>January 17, 2017</study_first_submitted>
  <study_first_submitted_qc>January 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 23, 2017</study_first_posted>
  <results_first_submitted>October 6, 2021</results_first_submitted>
  <results_first_submitted_qc>February 11, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">March 9, 2022</results_first_posted>
  <last_update_submitted>March 8, 2022</last_update_submitted>
  <last_update_submitted_qc>March 8, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 17, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Pseudomonas aeruginosa</keyword>
  <keyword>pneumonia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pneumonia</mesh_term>
    <mesh_term>Pseudomonas Infections</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anti-Bacterial Agents</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>November 9, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/09/NCT03027609/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>August 13, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/09/NCT03027609/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>AR-105</title>
          <description>One intravenous infusion of AR-105 20mg/'kg&#xD;
AR-105: monoclonal antibody</description>
        </group>
        <group group_id="P2">
          <title>Control</title>
          <description>Matching placebo&#xD;
placebo: matching placebo</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="79">Safety and ITT population</participants>
                <participants group_id="P2" count="79">Safety and ITT population</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="49">Safety and ITT population</participants>
                <participants group_id="P2" count="62">Safety and ITT population</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
                <participants group_id="P2" count="17"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>AR-105</title>
          <description>One intravenous infusion of AR-105 20mg/'kg&#xD;
AR-105: monoclonal antibody</description>
        </group>
        <group group_id="B2">
          <title>Control</title>
          <description>Matching placebo&#xD;
placebo: matching placebo</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="79"/>
            <count group_id="B2" value="79"/>
            <count group_id="B3" value="158"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="63.5" spread="13.83"/>
                    <measurement group_id="B2" value="61.2" spread="15.58"/>
                    <measurement group_id="B3" value="62.3" spread="14.73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Age &lt;/= 64 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="40"/>
                    <measurement group_id="B2" value="39"/>
                    <measurement group_id="B3" value="79"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Age &gt; 64 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="39"/>
                    <measurement group_id="B2" value="40"/>
                    <measurement group_id="B3" value="79"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                    <measurement group_id="B2" value="21"/>
                    <measurement group_id="B3" value="38"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="62"/>
                    <measurement group_id="B2" value="58"/>
                    <measurement group_id="B3" value="120"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="73"/>
                    <measurement group_id="B2" value="74"/>
                    <measurement group_id="B3" value="147"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <description>Number of participants per Country</description>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Hungary</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Czechia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ukraine</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Belarus</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Russia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                    <measurement group_id="B2" value="21"/>
                    <measurement group_id="B3" value="42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Spain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Greece</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Belgium</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Taiwan</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Georgia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>France</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>South Korea</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>World Regions</title>
          <description>Actual Regions of Enrollment</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Americas</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Eastern Europe</title>
                  <measurement_list>
                    <measurement group_id="B1" value="50"/>
                    <measurement group_id="B2" value="50"/>
                    <measurement group_id="B3" value="100"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Western Europe</title>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                    <measurement group_id="B2" value="22"/>
                    <measurement group_id="B3" value="44"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asia</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Clinical Cure on Day 21</title>
        <description>A summary of the number (%) of patients who were cured on or before Day 21 (micro-ITT population) is provided, by treatment group</description>
        <time_frame>21 days following dosing</time_frame>
        <group_list>
          <group group_id="O1">
            <title>AR-105</title>
            <description>One intravenous infusion of AR-105 20mg/'kg&#xD;
AR-105: monoclonal antibody</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Matching placebo&#xD;
placebo: matching placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Clinical Cure on Day 21</title>
          <description>A summary of the number (%) of patients who were cured on or before Day 21 (micro-ITT population) is provided, by treatment group</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="70"/>
                <count group_id="O2" value="67"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Observed Cured</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34"/>
                    <measurement group_id="O2" value="37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Imputed Cured</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not Cured</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25"/>
                    <measurement group_id="O2" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Reinfection same pathogen</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>New Infection Different Pathogen</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>New infection Unknown pathogen</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>comparison between the treatment and placebo</non_inferiority_desc>
            <p_value>0.6154</p_value>
            <p_value_desc>P-value was obtained with the stratified CMH test adjusted for baseline randomization strata</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Risk Difference (RD)</param_type>
            <param_value>-5.54</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-21.9</ci_lower_limit>
            <ci_upper_limit>10.8</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Clinical Cure on Day 7</title>
        <description>A summary of the number (%) of patients who were cured on or before Day 7 (micro-ITT population) is provided, by treatment group</description>
        <time_frame>7 days following dosing</time_frame>
        <group_list>
          <group group_id="O1">
            <title>AR-105</title>
            <description>One intravenous infusion of AR-105 20mg/'kg&#xD;
AR-105: monoclonal antibody</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Matching placebo&#xD;
placebo: matching placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Clinical Cure on Day 7</title>
          <description>A summary of the number (%) of patients who were cured on or before Day 7 (micro-ITT population) is provided, by treatment group</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="70"/>
                <count group_id="O2" value="67"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Cured Observed</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                    <measurement group_id="O2" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cured Imputed</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not Cured</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="52"/>
                    <measurement group_id="O2" value="47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Re-infection Same Pathogen</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>New Infection Different Pathogen</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>New Infection Unknown Pathogen</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Comparison between the treatment and placebo</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.8426</p_value>
            <p_value_desc>P-value was obtained with the stratified CMH test adjusted for baseline randomization strata</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Risk Difference (RD)</param_type>
            <param_value>4.01</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-18.5</ci_lower_limit>
            <ci_upper_limit>10.5</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Clinical Cure on Day 14</title>
        <description>A summary of the number (%) of patients who were cured on or before Day 14 (micro-ITT population) is provided by treatment group</description>
        <time_frame>14 days following dosing</time_frame>
        <group_list>
          <group group_id="O1">
            <title>AR-105</title>
            <description>One intravenous infusion of AR-105 20mg/'kg&#xD;
AR-105: monoclonal antibody</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Matching placebo&#xD;
placebo: matching placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Clinical Cure on Day 14</title>
          <description>A summary of the number (%) of patients who were cured on or before Day 14 (micro-ITT population) is provided by treatment group</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="70"/>
                <count group_id="O2" value="67"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Observed Cured</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36"/>
                    <measurement group_id="O2" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Imputed Cured</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not Cured</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29"/>
                    <measurement group_id="O2" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Reinfection same pathogen</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>New Infection Different Pathogen</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>New infection Unknown Pathogen</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Comparison between the treatment and placebo</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>comparison between the treatment and placebo</non_inferiority_desc>
            <p_value>0.3562</p_value>
            <p_value_desc>P-value was obtained with the stratified CMH test adjusted for baseline randomization strata</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>P value CMH</param_type>
            <param_value>3.6</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-13.1</ci_lower_limit>
            <ci_upper_limit>20.3</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Clinical Cure on Day 28</title>
        <description>A summary of the number (%) of patients who were cured on or before Day 28 (micro-ITT population) is provided by treatment group</description>
        <time_frame>28 days following dosing</time_frame>
        <group_list>
          <group group_id="O1">
            <title>AR-105</title>
            <description>One intravenous infusion of AR-105 20mg/'kg&#xD;
AR-105: monoclonal antibody</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Matching placebo&#xD;
placebo: matching placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Clinical Cure on Day 28</title>
          <description>A summary of the number (%) of patients who were cured on or before Day 28 (micro-ITT population) is provided by treatment group</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="70"/>
                <count group_id="O2" value="67"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Observed Cured</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35"/>
                    <measurement group_id="O2" value="38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Imputed Cured</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not Cured</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23"/>
                    <measurement group_id="O2" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Reinfection same pathogen</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>New Infection Different Pathogen</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>New infection Unknown Pathogen</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Comparison between the treatment and placebo</non_inferiority_desc>
            <p_value>0.8472</p_value>
            <p_value_desc>P-value was obtained with the stratified CMH test adjusted for baseline randomization strata</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>P value CMH</param_type>
            <param_value>-2.81</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-18.9</ci_lower_limit>
            <ci_upper_limit>13.2</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Post-Hoc</type>
        <title>Absolute Difference Clinical Cure at Day 14 and 21 for Study 1</title>
        <description>Difference in percentage of clinical cure rates between the two treatment groups</description>
        <time_frame>Up to Day 21</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Subset AR-105 Study1</title>
            <description>Using the appropriate clinical severity, level of CRP and adequate antibiotic criteria, patients were subdivided into subgroups to identify a pattern in the clinical cure rates in both treatment groups. The results suggest the presence of heterogeneity of factors influencing the clinical cure rates, where only a quite small sample is evaluable. A subset of patients had the following characteristics and were found to belong to&#xD;
appropriate clinical Severity&#xD;
inadequate antibiotic regimen and&#xD;
lower 3rd quartile of level of CRP</description>
          </group>
          <group group_id="O2">
            <title>Subset Placebo Study1</title>
            <description>Using the appropriate clinical severity, level of CRP and adequate antibiotic criteria, patients were subdivided into subgroups to identify a pattern in the clinical cure rates in both treatment groups. The results suggest the presence of heterogeneity of factors influencing the clinical cure rates, where only a quite small sample is evaluable. A subset of patients had the following characteristics and were found to belong to&#xD;
appropriate clinical Severity&#xD;
inadequate antibiotic regimen and&#xD;
lower 3rd quartile of level of CRP</description>
          </group>
        </group_list>
        <measure>
          <title>Absolute Difference Clinical Cure at Day 14 and 21 for Study 1</title>
          <description>Difference in percentage of clinical cure rates between the two treatment groups</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Cured Day 14</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cured Day 21</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Data for Day 14</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.4616</p_value>
            <p_value_desc>Marginally statistically significant only if p&lt;0.1</p_value_desc>
            <method>Chi-squared</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>22.3</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-16.2</ci_lower_limit>
            <ci_upper_limit>60.6</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Data for Day 21</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.4053</p_value>
            <p_value_desc>Data for Day 21</p_value_desc>
            <method>Chi-squared</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>22.3</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-13.3</ci_lower_limit>
            <ci_upper_limit>57.8</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Post-Hoc</type>
        <title>Absolute Difference Clinical Cure at Day 14 and 21 for Study 2</title>
        <description>Difference in percentage of clinical cure rates between the two treatment groups</description>
        <time_frame>Up to Day 21</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Subset AR-105 Study2</title>
            <description>Using the appropriate clinical severity, level of CRP and adequate antibiotic criteria, patients were subdivided into subgroups to identify a pattern in the clinical cure rates in both treatment groups. The results suggest the presence of heterogeneity of factors influencing the clinical cure rates, where only a quite small sample is evaluable. A subset of patients had the following characteristics and were found to belong to&#xD;
appropriate clinical Severity&#xD;
inadequate antibiotic regimen and&#xD;
lower 3rd quartile of level of CRP</description>
          </group>
          <group group_id="O2">
            <title>Subset Placebo Study2</title>
            <description>Using the appropriate clinical severity, level of CRP and adequate antibiotic criteria, patients were subdivided into subgroups to identify a pattern in the clinical cure rates in both treatment groups. The results suggest the presence of heterogeneity of factors influencing the clinical cure rates, where only a quite small sample is evaluable. A subset of patients had the following characteristics and were found to belong to&#xD;
appropriate clinical Severity&#xD;
inadequate antibiotic regimen and&#xD;
lower 3rd quartile of level of CRP</description>
          </group>
        </group_list>
        <measure>
          <title>Absolute Difference Clinical Cure at Day 14 and 21 for Study 2</title>
          <description>Difference in percentage of clinical cure rates between the two treatment groups</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
                <count group_id="O2" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Cured Day 14</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cured Day 21</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Data for Day 14</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0833</p_value>
            <p_value_desc>Marginally statistically significant only if p&lt;0.1</p_value_desc>
            <method>Chi-squared</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>38.1</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-14.8</ci_lower_limit>
            <ci_upper_limit>90.9</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Data for Day 21</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.5151</p_value>
            <p_value_desc>Data for Day 21</p_value_desc>
            <method>Chi-squared</method>
            <method_desc>Marginally statistically significant only if p&lt;0.1 Day 21</method_desc>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>23.8</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-30.5</ci_lower_limit>
            <ci_upper_limit>78.1</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>1 month: from administration day (Day 0) up to Day 28 (28 days after administration)</time_frame>
      <group_list>
        <group group_id="E1">
          <title>AR-105</title>
          <description>One intravenous infusion of AR-105 20mg/'kg&#xD;
AR-105: monoclonal antibody</description>
        </group>
        <group group_id="E2">
          <title>Control</title>
          <description>Matching placebo&#xD;
placebo: matching placebo</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (19.1)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="25" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="36" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="22" subjects_at_risk="79"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="79"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Acute left ventricular failure</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Acute myocardial infarction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Cardiac arrest</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Cardiac failure</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Cardiac failure acute</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Cardiac failure congestive</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Cardio-respiratory arrest</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Cardiopulmonary failure</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Cardiovascular insufficiency</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Myocardial infarction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Rhythm idioventricular</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="79"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Congenital, familial and genetic disorders</title>
            <event_list>
              <event>
                <sub_title>Tracheo-oesophageal fistula</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="79"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Colitis ischaemic</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Duodenal ulcer</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Gastric ulcer</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Lower gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Oesophageal ulcer</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Upper gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="79"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Cardiac death</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Multiple organ dysfunction syndrome</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Systemic inflammatory response syndrome</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="79"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Abdominal abscess</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Bacteraemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Cholecystitis infective</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Fungal sepsis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Lung abscess</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Pneumonia bacterial</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Pneumonia cytomegaloviral</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Pneumonia pseudomonal</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Pneumonia staphylococcal</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Postoperative wound infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Septic shock</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Systemic candida</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="79"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Brain herniation</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Gastrointestinal stoma complication</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="79"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Transaminases increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="79"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Rhabdomyolysis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="79"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Brain oedema</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Coma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Neuropathy peripheral</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="79"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Acute kidney injury</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="79"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Acute respiratory distress syndrome</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Acute respiratory failure</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Chronic obstructive pulmonary disease</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Pneumothorax</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Pulmonary embolism</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Respiratory distress</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Respiratory failure</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="79"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Circulatory Collapse</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Haemodynamic instability</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Shock</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Shock haemorrhagic</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Arterial rupture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="79"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA (19.1)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="73" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="73" subjects_at_risk="79"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" subjects_affected="16" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="79"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Bradycardia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="79"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="79"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Multiple organ dysfunction syndrome</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="79"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Cystitis</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Septic shock</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Tracheobronchitis</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="79"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="79"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperkalaemia</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Hypernatraemia</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Hypovolaemia</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="79"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Agitation</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Brain oedema</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Delirium</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="79"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Acute kidney injury</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="79"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Hydrothorax</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Pneumothorax</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Respiratory failure</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Tachypnoea</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="79"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Decubitus ulcer</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="79"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="79"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>A post-hoc analysis was performed on the data reviewed by the AC, using the appropriate clinical severity, adequate antibiotic criteria and the inflammatory status of the patient (level of C-reactive protein [CRP]).</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Lynne Deans</name_or_title>
      <organization>Aridis Pharmaceutical Inc</organization>
      <phone>001-925200 ext 3089</phone>
      <email>deansl@aridispharma.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03027609
org study id: AR-105-002
nct id: NCT03027609
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
Prospective, double-blind, randomized assessment of the efficacy, safety and pharmacokinetic
      of Aerucin® as adjunct treatment (in addition to standard of care antibiotics) for pneumonia
      caused by P. aeruginosa.
This is a double-blind, randomized, placebo-controlled study of the human monoclonal antibody
      (mAb) AR-105 for the adjunctive therapeutic treatment of P. aeruginosa pneumonia in
      mechanically ventilated subjects. Subjects who are randomized will be treated with either
      standard of care (SOC) antibiotics plus placebo or SOC antibiotics plus AR-105. The study is
      being conducted at approximately 100 clinical sites across 17 countries. Subjects who meet
      all of the inclusion criteria and none of the exclusion criteria are screened by the
      microbiological culture test and/or rapid diagnostic test of an endotracheal aspirate to
      confirm the presence of an active P. aeruginosa infection. Following eligibility
      confirmation, the subject will be randomized in a 1:1 ratio to one of two treatment groups.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Clinical Cure on Day 21
time frame: 21 days following dosing
description: A summary of the number (%) of patients who were cured on or before Day 21 (micro-ITT population) is provided, by treatment group
measure: Clinical Cure on Day 7
time frame: 7 days following dosing
description: A summary of the number (%) of patients who were cured on or before Day 7 (micro-ITT population) is provided, by treatment group
measure: Clinical Cure on Day 14
time frame: 14 days following dosing
description: A summary of the number (%) of patients who were cured on or before Day 14 (micro-ITT population) is provided by treatment group
measure: Clinical Cure on Day 28
time frame: 28 days following dosing
description: A summary of the number (%) of patients who were cured on or before Day 28 (micro-ITT population) is provided by treatment group
arm group label: AR-105
arm group type: Experimental
description: One intravenous infusion of AR-105 20mg/'kg
arm group label: Control
arm group type: Placebo Comparator
description: Matching placebo
intervention type: Drug
intervention name: AR-105
description: monoclonal antibody
arm group label: AR-105
other name: Aerubumab
other name: Aerucin
intervention type: Drug
intervention name: Placebo
description: matching placebo (+ SOC antibiotics)
arm group label: Control
other name: Control (SOC antibiotics)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
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country: Australia
country: Belarus
country: Belgium
country: Czechia
country: France
country: Georgia
country: Greece
country: Hungary
country: Korea, Republic of
country: Mexico
country: Peru
country: Poland
country: Russian Federation
country: Spain
country: Taiwan
country: Ukraine
country: United States
responsible party type: Sponsor
mesh term: Pneumonia
mesh term: Pseudomonas Infections
mesh term: Anti-Bacterial Agents
sharing ipd: No
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limitations and caveats: A post-hoc analysis was performed on the data reviewed by the AC, using the appropriate clinical severity, adequate antibiotic criteria and the inflammatory status of the patient (level of C-reactive protein [CRP]).
point of contact: 