<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/NCT02979951</url>
  </required_header>
  <id_info>
    <org_study_id>FORTRESS</org_study_id>
    <nct_id>NCT02979951</nct_id>
  </id_info>
  <brief_title>Fosfomycin i.v. for Treatment of Severely Infected Patients</brief_title>
  <acronym>FORTRESS</acronym>
  <official_title>A European, Multicentre, Non-comparative, Non-interventional, Prospective Clinical Registry to Evaluate the Clinical Outcome and Safety of the Treatment of Severely Infected Patients With Fosfomycin i.v.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Infectopharm Arzneimittel GmbH</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>INPADS GmbH</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Dr. Oestreich + Partner GmbH</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Infectopharm Arzneimittel GmbH</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this European, multicentric, prospective, non-interventional study is to&#xD;
      document and evaluate the efficacy and safety of the treatment of severely infected patients&#xD;
      with intravenously administered fosfomycin, including patients with osteomyelitis,&#xD;
      complicated urinary tract infection, nosocomial lower respiratory tract infection, bacterial&#xD;
      meningitis/central nervous system infection, bacteraemia/sepsis, skin and soft tissue&#xD;
      infection, endocarditis or other infections, each as far as covered by the respective&#xD;
      nationally relevant SmPC.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date>December 2016</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Anticipated">December 2023</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of patients with clinical success as defined as clinical cure or clinical improvement</measure>
    <time_frame>Analysed at EOT (&quot;End of fosfomycin treatment&quot;, up to 6 months after start of fosfomycin treatment)</time_frame>
    <description>Definition of clinical cure (both criteria must be fulfilled):&#xD;
Resolution of signs and symptoms and&#xD;
microbiological cure or no additional antibiotic therapy for the targeted infection necessary.&#xD;
Definition of clinical improvement (both criteria must be fulfilled):&#xD;
Partial resolution of signs and symptoms and&#xD;
microbiological cure or no additional antibiotic therapy for the targeted infection necessary.&#xD;
Definition of microbiological cure:&#xD;
Elimination of the relevant pathogen(s) at the relevant site(s) of infection (at least one negative culture) or&#xD;
in case &quot;no sample available/indicated due to sufficient clinical response&quot;, pathogen elimination is considered.&#xD;
Time Frame:&#xD;
Time point &quot;End of fosfomycin treatment&quot; (EOT) is reached at the day of the last fosfomycin application in the course of the treatment schedule for the targeted infection (i.e., in case of a multiple stage treatment schedule, the end of the last fosfomycin treatment phase).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Microbiological cure</measure>
    <time_frame>Analysed at &quot;initial response&quot; (not later than 7 days after start of fosfomycin treatment)</time_frame>
    <description>Definition of microbiological cure:&#xD;
Elimination of the relevant pathogen(s) at the relevant site(s) of infection (at least one negative culture) or&#xD;
in case &quot;no sample available/indicated due to sufficient clinical response&quot;, pathogen elimination is considered.&#xD;
Time Frame:&#xD;
Time point &quot;initial response&quot; is defined to be after start of fosfomycin treatment and not later than 7 days after start of fosfomycin treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Microbiological cure</measure>
    <time_frame>Analysed at EOT (&quot;End of fosfomycin treatment&quot;, up to 6 months after start of fosfomycin treatment)</time_frame>
    <description>Definition of microbiological cure:&#xD;
Elimination of the relevant pathogen(s) at the relevant site(s) of infection (at least one negative culture) or&#xD;
in case &quot;no sample available/indicated due to sufficient clinical response&quot;, pathogen elimination is considered.&#xD;
Time Frame:&#xD;
Time point &quot;End of fosfomycin treatment&quot; (EOT) is reached at the day of the last fosfomycin application in the course of the treatment schedule for the targeted infection (i.e., in case of a multiple stage treatment schedule, the end of the last fosfomycin treatment phase).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Microbiological cure</measure>
    <time_frame>Analysed at TOC (&quot;Test of cure&quot;, up to 6 months after start of fosfomycin treatment)</time_frame>
    <description>Definition of microbiological cure:&#xD;
Elimination of the relevant pathogen(s) at the relevant site(s) of infection (at least one negative culture) or&#xD;
in case &quot;no sample available/indicated due to sufficient clinical response&quot;, pathogen elimination is considered.&#xD;
Time Frame:&#xD;
Time point &quot;TOC&quot; is defined to be not earlier than EOT and not later than end of hospital stay of the patient.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Microbiological cure</measure>
    <time_frame>Analysed at follow-up (within one year after start of fosfomycin treatment) (only for indication &quot;osteomyelitis&quot;)</time_frame>
    <description>Definition of microbiological cure:&#xD;
Elimination of the relevant pathogen(s) at the relevant site(s) of infection (at least one negative culture) or&#xD;
in case &quot;no sample available/indicated due to sufficient clinical response&quot;, pathogen elimination is considered.&#xD;
Time Frame:&#xD;
Defined to be after end of hospital stay + within 1 year after start of fosfomycin treatment. Either the latest visit after &quot;End of hospital stay&quot; within 1 year after start of fosfomycin treatment or, if applicable, the visit in this time frame assessing a clinical failure/relapse.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical success as defined as clinical cure or clinical improvement</measure>
    <time_frame>Analysed at &quot;initial response&quot; (not later than 7 days after start of fosfomycin treatment)</time_frame>
    <description>Definition of clinical cure (both criteria must be fulfilled):&#xD;
Resolution of signs and symptoms and&#xD;
microbiological cure or no additional antibiotic therapy for the targeted infection necessary.&#xD;
Definition of clinical improvement (both criteria must be fulfilled):&#xD;
Partial resolution of signs and symptoms and&#xD;
microbiological cure or no additional antibiotic therapy for the targeted infection necessary.&#xD;
Definition of microbiological cure:&#xD;
Elimination of the relevant pathogen(s) at the relevant site(s) of infection (at least one negative culture) or&#xD;
in case &quot;no sample available/indicated due to sufficient clinical response&quot;, pathogen elimination is considered.&#xD;
Time Frame:&#xD;
Time point &quot;initial response&quot; is defined to be after start of fosfomycin treatment and not later than 7 days after start of fosfomycin treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical success as defined as clinical cure or clinical improvement</measure>
    <time_frame>Analysed at TOC (&quot;Test of cure&quot;, up to 6 months after start of fosfomycin treatment)</time_frame>
    <description>Definition of clinical cure (both criteria must be fulfilled):&#xD;
Resolution of signs and symptoms and&#xD;
microbiological cure or no additional antibiotic therapy for the targeted infection necessary.&#xD;
Definition of clinical improvement (both criteria must be fulfilled):&#xD;
Partial resolution of signs and symptoms and&#xD;
microbiological cure or no additional antibiotic therapy for the targeted infection necessary.&#xD;
Definition of microbiological cure:&#xD;
Elimination of the relevant pathogen(s) at the relevant site(s) of infection (at least one negative culture) or&#xD;
in case &quot;no sample available/indicated due to sufficient clinical response&quot;, pathogen elimination is considered.&#xD;
Time Frame:&#xD;
Time point &quot;TOC&quot; is defined to be not earlier than EOT and not later than end of hospital stay of the patient.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical success as defined as clinical cure or clinical improvement</measure>
    <time_frame>Analysed at follow-up (within one year after start of fosfomycin treatment) (only for indication &quot;osteomyelitis&quot;)</time_frame>
    <description>Definition of clinical cure (both criteria must be fulfilled):&#xD;
Resolution of signs and symptoms and&#xD;
microbiological cure or no additional antibiotic therapy for the targeted infection necessary.&#xD;
Definition of clinical improvement (both criteria must be fulfilled):&#xD;
Partial resolution of signs and symptoms and&#xD;
microbiological cure or no additional antibiotic therapy for the targeted infection necessary.&#xD;
Definition of microbiological cure:&#xD;
Elimination of the relevant pathogen(s) at the relevant site(s) of infection (at least one negative culture) or&#xD;
in case &quot;no sample available/indicated due to sufficient clinical response&quot;, pathogen elimination is considered.&#xD;
Time Frame:&#xD;
Defined to be after end of hospital stay + within 1 year after start of fosfomycin treatment. Either the latest visit after &quot;End of hospital stay&quot; within 1 year after start of fosfomycin treatment or, if applicable, the visit in this time frame assessing a clinical failure/relapse.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical cure</measure>
    <time_frame>Analysed at EOT (&quot;End of fosfomycin treatment&quot;, up to 6 months after start of fosfomycin treatment)</time_frame>
    <description>Definition of clinical cure (both criteria must be fulfilled):&#xD;
Resolution of signs and symptoms and&#xD;
microbiological cure or no additional antibiotic therapy for the targeted infection necessary.&#xD;
Definition of microbiological cure:&#xD;
Elimination of the relevant pathogen(s) at the relevant site(s) of infection (at least one negative culture) or&#xD;
in case &quot;no sample available/indicated due to sufficient clinical response&quot;, pathogen elimination is considered.&#xD;
Time Frame:&#xD;
Time point &quot;End of fosfomycin treatment&quot; (EOT) is reached at the day of the last fosfomycin application in the course of the treatment schedule for the targeted infection (i.e., in case of a multiple stage treatment schedule, the end of the last fosfomycin treatment phase).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical cure</measure>
    <time_frame>Analysed at TOC (&quot;Test of cure&quot;, up to 6 months after start of fosfomycin treatment)</time_frame>
    <description>Definition of clinical cure (both criteria must be fulfilled):&#xD;
Resolution of signs and symptoms and&#xD;
microbiological cure or no additional antibiotic therapy for the targeted infection necessary.&#xD;
Definition of microbiological cure:&#xD;
Elimination of the relevant pathogen(s) at the relevant site(s) of infection (at least one negative culture) or&#xD;
in case &quot;no sample available/indicated due to sufficient clinical response&quot;, pathogen elimination is considered.&#xD;
Time Frame:&#xD;
Time point &quot;TOC&quot; is defined to be not earlier than EOT and not later than end of hospital stay of the patient.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical cure</measure>
    <time_frame>Analysed at follow-up (within one year after start of fosfomycin treatment) (only for indication &quot;osteomyelitis&quot;)</time_frame>
    <description>Definition of clinical cure (both criteria must be fulfilled):&#xD;
Resolution of signs and symptoms and&#xD;
microbiological cure or no additional antibiotic therapy for the targeted infection necessary.&#xD;
Definition of microbiological cure:&#xD;
Elimination of the relevant pathogen(s) at the relevant site(s) of infection (at least one negative culture) or&#xD;
in case &quot;no sample available/indicated due to sufficient clinical response&quot;, pathogen elimination is considered.&#xD;
Time Frame:&#xD;
Defined to be after end of hospital stay + within 1 year after start of fosfomycin treatment. Either the latest visit after &quot;End of hospital stay&quot; within 1 year after start of fosfomycin treatment or, if applicable, the visit in this time frame assessing a clinical failure/relapse.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical improvement</measure>
    <time_frame>Analysed at &quot;initial response&quot; (not later than 7 days after start of fosfomycin treatment)</time_frame>
    <description>Definition of clinical improvement (both criteria must be fulfilled):&#xD;
Partial resolution of signs and symptoms and&#xD;
microbiological cure or no additional antibiotic therapy for the targeted infection necessary.&#xD;
Definition of microbiological cure:&#xD;
Elimination of the relevant pathogen(s) at the relevant site(s) of infection (at least one negative culture) or&#xD;
in case &quot;no sample available/indicated due to sufficient clinical response&quot;, pathogen elimination is considered.&#xD;
Time Frame:&#xD;
Time point &quot;initial response&quot; is defined to be after start of fosfomycin treatment and not later than 7 days after start of fosfomycin treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical improvement</measure>
    <time_frame>Analysed at EOT (&quot;End of fosfomycin treatment&quot;, up to 6 months after start of fosfomycin treatment)</time_frame>
    <description>Definition of clinical improvement (both criteria must be fulfilled):&#xD;
Partial resolution of signs and symptoms and&#xD;
microbiological cure or no additional antibiotic therapy for the targeted infection necessary.&#xD;
Definition of microbiological cure:&#xD;
Elimination of the relevant pathogen(s) at the relevant site(s) of infection (at least one negative culture) or&#xD;
in case &quot;no sample available/indicated due to sufficient clinical response&quot;, pathogen elimination is considered.&#xD;
Time Frame:&#xD;
Time point &quot;End of fosfomycin treatment&quot; (EOT) is reached at the day of the last fosfomycin application in the course of the treatment schedule for the targeted infection (i.e., in case of a multiple stage treatment schedule, the end of the last fosfomycin treatment phase).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical improvement</measure>
    <time_frame>Analysed at TOC (&quot;Test of cure&quot;, up to 6 months after start of fosfomycin treatment)</time_frame>
    <description>Definition of clinical improvement (both criteria must be fulfilled):&#xD;
Partial resolution of signs and symptoms and&#xD;
microbiological cure or no additional antibiotic therapy for the targeted infection necessary.&#xD;
Definition of microbiological cure:&#xD;
Elimination of the relevant pathogen(s) at the relevant site(s) of infection (at least one negative culture) or&#xD;
in case &quot;no sample available/indicated due to sufficient clinical response&quot;, pathogen elimination is considered.&#xD;
Time Frame:&#xD;
Time point &quot;TOC&quot; is defined to be not earlier than EOT and not later than end of hospital stay of the patient.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical improvement</measure>
    <time_frame>Analysed at follow-up (within one year after start of fosfomycin treatment) (only for indication &quot;osteomyelitis&quot;)</time_frame>
    <description>Definition of clinical improvement (both criteria must be fulfilled):&#xD;
Partial resolution of signs and symptoms and&#xD;
microbiological cure or no additional antibiotic therapy for the targeted infection necessary.&#xD;
Definition of microbiological cure:&#xD;
Elimination of the relevant pathogen(s) at the relevant site(s) of infection (at least one negative culture) or&#xD;
in case &quot;no sample available/indicated due to sufficient clinical response&quot;, pathogen elimination is considered.&#xD;
Time Frame:&#xD;
Defined to be after end of hospital stay + within 1 year after start of fosfomycin treatment. Either the latest visit after &quot;End of hospital stay&quot; within 1 year after start of fosfomycin treatment or, if applicable, the visit in this time frame assessing a clinical failure/relapse.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sodium serum levels</measure>
    <time_frame>On every day from start of fosfomycin treatment until end of hospital stay (up to 6 months after start of fosfomycin treatment)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Potassium serum levels</measure>
    <time_frame>On every day from start of fosfomycin treatment until end of hospital stay (up to 6 months after start of fosfomycin treatment)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse events</measure>
    <time_frame>On every day from start of fosfomycin treatment until end of follow-up (up to one year after start of fosfomycin treatment)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Non-serious adverse events</measure>
    <time_frame>On every day from start of fosfomycin treatment until end of follow-up (up to one year after start of fosfomycin treatment)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serious adverse events</measure>
    <time_frame>On every day from start of fosfomycin treatment until end of follow-up (up to one year after start of fosfomycin treatment)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cases of death</measure>
    <time_frame>On every day from start of fosfomycin treatment until end of follow-up (up to one year after start of fosfomycin treatment)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse drug reactions (ADRs)</measure>
    <time_frame>On every day from start of fosfomycin treatment until end of follow-up (up to one year after start of fosfomycin treatment)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serious adverse drug reactions (SADRs)</measure>
    <time_frame>On every day from start of fosfomycin treatment until end of follow-up (up to one year after start of fosfomycin treatment)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dropouts due to treatment failure or due to adverse events</measure>
    <time_frame>On every day from start of fosfomycin treatment until end of follow-up (up to one year after start of fosfomycin treatment)</time_frame>
  </secondary_outcome>
  <enrollment type="Anticipated">1000</enrollment>
  <condition>Bacterial Infections</condition>
  <condition>Bone Diseases, Infectious</condition>
  <condition>Osteomyelitis</condition>
  <condition>Central Nervous System Bacterial Infections</condition>
  <condition>Meningitis, Bacterial</condition>
  <condition>Encephalitis</condition>
  <condition>Brain Abscess</condition>
  <condition>Urinary Tract Infections</condition>
  <condition>Respiratory Tract Infections</condition>
  <condition>Pneumonia, Bacterial</condition>
  <condition>Skin Diseases, Bacterial</condition>
  <condition>Soft Tissue Infections</condition>
  <condition>Intraabdominal Infections</condition>
  <condition>Sepsis</condition>
  <condition>Bacteremia</condition>
  <condition>Endocarditis, Bacterial</condition>
  <eligibility>
    <study_pop>
      <textblock>
        All patients of the participating study sites (clinics specialised and experienced in the&#xD;
        management and treatment of patients suffering from (a part of) the included diseases as&#xD;
        mentioned in the respective inclusion criterion), who fulfill all inclusion criteria and do&#xD;
        not fulfill any of the exclusion criteria, are eligible for participation in the FORTRESS&#xD;
        study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female patients aged ≥ 18 years&#xD;
&#xD;
          -  Treatment with fosfomycin according to the (national) Summary of Product&#xD;
             Characteristics (SmPC) of fosfomycin i.v.&#xD;
&#xD;
          -  Patients with osteomyelitis, complicated urinary tract infection, nosocomial lower&#xD;
             respiratory tract infection, bacterial meningitis/central nervous system infection,&#xD;
             bacteraemia/sepsis, skin and soft tissue infection, endocarditis or other infection,&#xD;
             each as far as covered by the respective nationally relevant SmPC&#xD;
&#xD;
          -  Written informed consent of the participant (or person in charge in case of patients&#xD;
             incapable of giving consent)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous documentation of the patient in the present study&#xD;
&#xD;
          -  Patients participating in an interventional clinical trial&#xD;
&#xD;
          -  Patients with known hypersensitivity to fosfomycin or any of the excipients&#xD;
&#xD;
          -  Terminally ill patients&#xD;
&#xD;
          -  Patients with &quot;do not resuscitate order&quot;&#xD;
&#xD;
          -  Palliative treatment approach&#xD;
&#xD;
          -  Failure of &gt; 3 of the following organ systems: respiratory system, nervous system,&#xD;
             cardiovascular system, liver, coagulation, kidney&#xD;
&#xD;
          -  Manifest Human Immunodeficiency Virus (HIV) disease (Acquired Immunodeficiency&#xD;
             Syndrome, AIDS)&#xD;
&#xD;
          -  Fosfomycin treatment as 4th line treatment or at later stage&#xD;
&#xD;
          -  Patients with involvement of fungi or mycobacteria in the targeted infection&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Klaus-Friedrich Bodmann, Dr.</last_name>
    <role>Study Director</role>
    <affiliation>Klinik Nordoberpfalz AG, Klinikum Weiden</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Thomas Borrmann, Dr.</last_name>
    <email>studien@infectopharm.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Katja Eifert</last_name>
    <email>studien@infectopharm.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Landeskrankenhaus Hall - Tirol Kliniken</name>
      <address>
        <city>Hall In Tirol</city>
        <country>Austria</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ivo Graziadei, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Klinikum Wels-Grieskirchen, Institut für Hygiene und Mikrobiologie</name>
      <address>
        <city>Wels</city>
        <country>Austria</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Rainer Gattringer, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>AKH Wien, Universitätsklinik für Innere Medizin 1</name>
      <address>
        <city>Wien</city>
        <country>Austria</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Matthias Vossen, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Universitätsmedizin Charité</name>
      <address>
        <city>Berlin</city>
        <zip>10177</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Claudia Spieß, Prof.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Vivantes Kliniken Neukölln</name>
      <address>
        <city>Berlin</city>
        <zip>12351</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Herwig Gerlach, Prof.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Städtisches Klinikum Braunschweig</name>
      <address>
        <city>Braunschweig</city>
        <zip>38126</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jan Kielstein, Dr.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Universitäts Düsseldorf; Klinik für Anästhesiologie</name>
      <address>
        <city>Dusseldorf</city>
        <zip>40225</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Detlef Kindgen-Milles, Prof.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Frankfurt</name>
      <address>
        <city>Frankfurt</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Simone Lindau</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Universität Hamburg-Eppendorf</name>
      <address>
        <city>Hamburg</city>
        <zip>20251</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Stefan Kluge, Prof.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Jena; Zentrum für Infektionsmedizin</name>
      <address>
        <city>Jena</city>
        <zip>07740</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mathias Pletz, Prof.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Schleswig-Holstein</name>
      <address>
        <city>Kiel</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Norbert Weiler, Prof.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Universitätsklinik Schleswig-Holstein</name>
      <address>
        <city>Lübeck</city>
        <zip>23538</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jan Rupp, Prof.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>LMU München</name>
      <address>
        <city>München</city>
        <zip>81377</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Michael Zoller, Dr.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Klinikum Oldenburg</name>
      <address>
        <city>Oldenburg in Holstein</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ulf Günther, PD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Universitätsklinik Regensburg; Klinik für Anästhesiologie</name>
      <address>
        <city>Regensburg</city>
        <zip>93053</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Martin Kieninger, Dr. med.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Kliniken Nordoberpfalz</name>
      <address>
        <city>Weiden</city>
        <zip>92637</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Andreas Faltlhauser, Dr.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>RIO Univ. Hospital, Dept of Pathology, Division of Infectious Diseases</name>
      <address>
        <city>Patras</city>
        <country>Greece</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Markos Marangos, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera S.Croce e Carle</name>
      <address>
        <city>Cuneo</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Valerio Del Bono, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Ospedale L. Sacco</name>
      <address>
        <city>Mailand</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Istituto Mediterraneo per i Trapianti Ismett IRCCS</name>
      <address>
        <city>Palermo</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Alessandra Mularoni, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Policlinico Umberto I, Malattie Infettive</name>
      <address>
        <city>Rom</city>
        <zip>00161</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mario Venditti, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Lazzaro Spallanzani</name>
      <address>
        <city>Rom</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Nicola Petrosillo, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Royal Bolton Hospital</name>
      <address>
        <city>Bolton</city>
        <zip>BL4 0JR</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hull &amp; East Yorkshire Hospitals NHS Trust</name>
      <address>
        <city>Cottingham</city>
        <zip>HU16 5JQ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Gavin Barlow, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Ninewells Hospital</name>
      <address>
        <city>Dundee</city>
        <zip>DD1 9SY</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Benjamin Parcell, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>University Hospital Crosshouse</name>
      <address>
        <city>Kilmarnock</city>
        <zip>KA2OBB</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Abhijit Bal, MD</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Austria</country>
    <country>Germany</country>
    <country>Greece</country>
    <country>Italy</country>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>November 24, 2016</study_first_submitted>
  <study_first_submitted_qc>December 1, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 2, 2016</study_first_posted>
  <last_update_submitted>February 28, 2023</last_update_submitted>
  <last_update_submitted_qc>February 28, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 1, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Observational Study</keyword>
  <keyword>Non-Interventional Study</keyword>
  <keyword>Registries</keyword>
  <keyword>Prospective</keyword>
  <keyword>Monitored</keyword>
  <keyword>Multicentric</keyword>
  <keyword>International</keyword>
  <keyword>Fosfomycin</keyword>
  <keyword>Infectofos</keyword>
  <keyword>Fomicyt</keyword>
  <keyword>Bacterial Infections</keyword>
  <keyword>Gram-Negative Bacterial Infections</keyword>
  <keyword>Gram-Positive Bacterial Infections</keyword>
  <keyword>Bone Diseases, Infectious</keyword>
  <keyword>Osteomyelitis</keyword>
  <keyword>Central Nervous System Bacterial Infections</keyword>
  <keyword>Meningitis, Bacterial</keyword>
  <keyword>Encephalitis</keyword>
  <keyword>Brain Abscess</keyword>
  <keyword>Urinary Tract Infections</keyword>
  <keyword>Respiratory Tract Infections</keyword>
  <keyword>Pneumonia, Bacterial</keyword>
  <keyword>Skin Diseases, Bacterial</keyword>
  <keyword>Soft Tissue Infections</keyword>
  <keyword>Intraabdominal Infections</keyword>
  <keyword>Sepsis</keyword>
  <keyword>Bacteremia</keyword>
  <keyword>Endocarditis, Bacterial</keyword>
  <keyword>Treatment Outcome</keyword>
  <keyword>Clinical Efficacy</keyword>
  <keyword>Microbiological Efficacy</keyword>
  <keyword>Safety</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>Pneumonia</mesh_term>
    <mesh_term>Urinary Tract Infections</mesh_term>
    <mesh_term>Respiratory Tract Infections</mesh_term>
    <mesh_term>Bacterial Infections</mesh_term>
    <mesh_term>Bacteremia</mesh_term>
    <mesh_term>Abscess</mesh_term>
    <mesh_term>Osteomyelitis</mesh_term>
    <mesh_term>Soft Tissue Infections</mesh_term>
    <mesh_term>Pneumonia, Bacterial</mesh_term>
    <mesh_term>Intraabdominal Infections</mesh_term>
    <mesh_term>Skin Diseases, Bacterial</mesh_term>
    <mesh_term>Endocarditis, Bacterial</mesh_term>
    <mesh_term>Meningitis, Bacterial</mesh_term>
    <mesh_term>Brain Abscess</mesh_term>
    <mesh_term>Bone Diseases, Infectious</mesh_term>
    <mesh_term>Central Nervous System Bacterial Infections</mesh_term>
    <mesh_term>Bone Diseases</mesh_term>
    <mesh_term>Meningitis</mesh_term>
    <mesh_term>Encephalitis</mesh_term>
    <mesh_term>Endocarditis</mesh_term>
    <mesh_term>Skin Diseases</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT02979951
org study id: FORTRESS
nct id: NCT02979951
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
The purpose of this European, multicentric, prospective, non-interventional study is to
      document and evaluate the efficacy and safety of the treatment of severely infected patients
      with intravenously administered fosfomycin, including patients with osteomyelitis,
      complicated urinary tract infection, nosocomial lower respiratory tract infection, bacterial
      meningitis/central nervous system infection, bacteraemia/sepsis, skin and soft tissue
      infection, endocarditis or other infections, each as far as covered by the respective
      nationally relevant SmPC.
observational model: Cohort
time perspective: Prospective
measure: Percentage of patients with clinical success as defined as clinical cure or clinical improvement
time frame: Analysed at EOT ("End of fosfomycin treatment", up to 6 months after start of fosfomycin treatment)
description: Definition of clinical cure (both criteria must be fulfilled):
Resolution of signs and symptoms and
microbiological cure or no additional antibiotic therapy for the targeted infection necessary.
Definition of clinical improvement (both criteria must be fulfilled):
Partial resolution of signs and symptoms and
microbiological cure or no additional antibiotic therapy for the targeted infection necessary.
Definition of microbiological cure:
Elimination of the relevant pathogen(s) at the relevant site(s) of infection (at least one negative culture) or
in case "no sample available/indicated due to sufficient clinical response", pathogen elimination is considered.
Time Frame:
Time point "End of fosfomycin treatment" (EOT) is reached at the day of the last fosfomycin application in the course of the treatment schedule for the targeted infection (i.e., in case of a multiple stage treatment schedule, the end of the last fosfomycin treatment phase).
measure: Microbiological cure
time frame: Analysed at "initial response" (not later than 7 days after start of fosfomycin treatment)
description: Definition of microbiological cure:
Elimination of the relevant pathogen(s) at the relevant site(s) of infection (at least one negative culture) or
in case "no sample available/indicated due to sufficient clinical response", pathogen elimination is considered.
Time Frame:
Time point "initial response" is defined to be after start of fosfomycin treatment and not later than 7 days after start of fosfomycin treatment.
measure: Microbiological cure
time frame: Analysed at EOT ("End of fosfomycin treatment", up to 6 months after start of fosfomycin treatment)
description: Definition of microbiological cure:
Elimination of the relevant pathogen(s) at the relevant site(s) of infection (at least one negative culture) or
in case "no sample available/indicated due to sufficient clinical response", pathogen elimination is considered.
Time Frame:
Time point "End of fosfomycin treatment" (EOT) is reached at the day of the last fosfomycin application in the course of the treatment schedule for the targeted infection (i.e., in case of a multiple stage treatment schedule, the end of the last fosfomycin treatment phase).
measure: Microbiological cure
time frame: Analysed at TOC ("Test of cure", up to 6 months after start of fosfomycin treatment)
description: Definition of microbiological cure:
Elimination of the relevant pathogen(s) at the relevant site(s) of infection (at least one negative culture) or
in case "no sample available/indicated due to sufficient clinical response", pathogen elimination is considered.
Time Frame:
Time point "TOC" is defined to be not earlier than EOT and not later than end of hospital stay of the patient.
measure: Microbiological cure
time frame: Analysed at follow-up (within one year after start of fosfomycin treatment) (only for indication "osteomyelitis")
description: Definition of microbiological cure:
Elimination of the relevant pathogen(s) at the relevant site(s) of infection (at least one negative culture) or
in case "no sample available/indicated due to sufficient clinical response", pathogen elimination is considered.
Time Frame:
Defined to be after end of hospital stay + within 1 year after start of fosfomycin treatment. Either the latest visit after "End of hospital stay" within 1 year after start of fosfomycin treatment or, if applicable, the visit in this time frame assessing a clinical failure/relapse.
measure: Clinical success as defined as clinical cure or clinical improvement
time frame: Analysed at "initial response" (not later than 7 days after start of fosfomycin treatment)
description: Definition of clinical cure (both criteria must be fulfilled):
Resolution of signs and symptoms and
microbiological cure or no additional antibiotic therapy for the targeted infection necessary.
Definition of clinical improvement (both criteria must be fulfilled):
Partial resolution of signs and symptoms and
microbiological cure or no additional antibiotic therapy for the targeted infection necessary.
Definition of microbiological cure:
Elimination of the relevant pathogen(s) at the relevant site(s) of infection (at least one negative culture) or
in case "no sample available/indicated due to sufficient clinical response", pathogen elimination is considered.
Time Frame:
Time point "initial response" is defined to be after start of fosfomycin treatment and not later than 7 days after start of fosfomycin treatment.
measure: Clinical success as defined as clinical cure or clinical improvement
time frame: Analysed at TOC ("Test of cure", up to 6 months after start of fosfomycin treatment)
description: Definition of clinical cure (both criteria must be fulfilled):
Resolution of signs and symptoms and
microbiological cure or no additional antibiotic therapy for the targeted infection necessary.
Definition of clinical improvement (both criteria must be fulfilled):
Partial resolution of signs and symptoms and
microbiological cure or no additional antibiotic therapy for the targeted infection necessary.
Definition of microbiological cure:
Elimination of the relevant pathogen(s) at the relevant site(s) of infection (at least one negative culture) or
in case "no sample available/indicated due to sufficient clinical response", pathogen elimination is considered.
Time Frame:
Time point "TOC" is defined to be not earlier than EOT and not later than end of hospital stay of the patient.
measure: Clinical success as defined as clinical cure or clinical improvement
time frame: Analysed at follow-up (within one year after start of fosfomycin treatment) (only for indication "osteomyelitis")
description: Definition of clinical cure (both criteria must be fulfilled):
Resolution of signs and symptoms and
microbiological cure or no additional antibiotic therapy for the targeted infection necessary.
Definition of clinical improvement (both criteria must be fulfilled):
Partial resolution of signs and symptoms and
microbiological cure or no additional antibiotic therapy for the targeted infection necessary.
Definition of microbiological cure:
Elimination of the relevant pathogen(s) at the relevant site(s) of infection (at least one negative culture) or
in case "no sample available/indicated due to sufficient clinical response", pathogen elimination is considered.
Time Frame:
Defined to be after end of hospital stay + within 1 year after start of fosfomycin treatment. Either the latest visit after "End of hospital stay" within 1 year after start of fosfomycin treatment or, if applicable, the visit in this time frame assessing a clinical failure/relapse.
measure: Clinical cure
time frame: Analysed at EOT ("End of fosfomycin treatment", up to 6 months after start of fosfomycin treatment)
description: Definition of clinical cure (both criteria must be fulfilled):
Resolution of signs and symptoms and
microbiological cure or no additional antibiotic therapy for the targeted infection necessary.
Definition of microbiological cure:
Elimination of the relevant pathogen(s) at the relevant site(s) of infection (at least one negative culture) or
in case "no sample available/indicated due to sufficient clinical response", pathogen elimination is considered.
Time Frame:
Time point "End of fosfomycin treatment" (EOT) is reached at the day of the last fosfomycin application in the course of the treatment schedule for the targeted infection (i.e., in case of a multiple stage treatment schedule, the end of the last fosfomycin treatment phase).
measure: Clinical cure
time frame: Analysed at TOC ("Test of cure", up to 6 months after start of fosfomycin treatment)
description: Definition of clinical cure (both criteria must be fulfilled):
Resolution of signs and symptoms and
microbiological cure or no additional antibiotic therapy for the targeted infection necessary.
Definition of microbiological cure:
Elimination of the relevant pathogen(s) at the relevant site(s) of infection (at least one negative culture) or
in case "no sample available/indicated due to sufficient clinical response", pathogen elimination is considered.
Time Frame:
Time point "TOC" is defined to be not earlier than EOT and not later than end of hospital stay of the patient.
measure: Clinical cure
time frame: Analysed at follow-up (within one year after start of fosfomycin treatment) (only for indication "osteomyelitis")
description: Definition of clinical cure (both criteria must be fulfilled):
Resolution of signs and symptoms and
microbiological cure or no additional antibiotic therapy for the targeted infection necessary.
Definition of microbiological cure:
Elimination of the relevant pathogen(s) at the relevant site(s) of infection (at least one negative culture) or
in case "no sample available/indicated due to sufficient clinical response", pathogen elimination is considered.
Time Frame:
Defined to be after end of hospital stay + within 1 year after start of fosfomycin treatment. Either the latest visit after "End of hospital stay" within 1 year after start of fosfomycin treatment or, if applicable, the visit in this time frame assessing a clinical failure/relapse.
measure: Clinical improvement
time frame: Analysed at "initial response" (not later than 7 days after start of fosfomycin treatment)
description: Definition of clinical improvement (both criteria must be fulfilled):
Partial resolution of signs and symptoms and
microbiological cure or no additional antibiotic therapy for the targeted infection necessary.
Definition of microbiological cure:
Elimination of the relevant pathogen(s) at the relevant site(s) of infection (at least one negative culture) or
in case "no sample available/indicated due to sufficient clinical response", pathogen elimination is considered.
Time Frame:
Time point "initial response" is defined to be after start of fosfomycin treatment and not later than 7 days after start of fosfomycin treatment.
measure: Clinical improvement
time frame: Analysed at EOT ("End of fosfomycin treatment", up to 6 months after start of fosfomycin treatment)
description: Definition of clinical improvement (both criteria must be fulfilled):
Partial resolution of signs and symptoms and
microbiological cure or no additional antibiotic therapy for the targeted infection necessary.
Definition of microbiological cure:
Elimination of the relevant pathogen(s) at the relevant site(s) of infection (at least one negative culture) or
in case "no sample available/indicated due to sufficient clinical response", pathogen elimination is considered.
Time Frame:
Time point "End of fosfomycin treatment" (EOT) is reached at the day of the last fosfomycin application in the course of the treatment schedule for the targeted infection (i.e., in case of a multiple stage treatment schedule, the end of the last fosfomycin treatment phase).
measure: Clinical improvement
time frame: Analysed at TOC ("Test of cure", up to 6 months after start of fosfomycin treatment)
description: Definition of clinical improvement (both criteria must be fulfilled):
Partial resolution of signs and symptoms and
microbiological cure or no additional antibiotic therapy for the targeted infection necessary.
Definition of microbiological cure:
Elimination of the relevant pathogen(s) at the relevant site(s) of infection (at least one negative culture) or
in case "no sample available/indicated due to sufficient clinical response", pathogen elimination is considered.
Time Frame:
Time point "TOC" is defined to be not earlier than EOT and not later than end of hospital stay of the patient.
measure: Clinical improvement
time frame: Analysed at follow-up (within one year after start of fosfomycin treatment) (only for indication "osteomyelitis")
description: Definition of clinical improvement (both criteria must be fulfilled):
Partial resolution of signs and symptoms and
microbiological cure or no additional antibiotic therapy for the targeted infection necessary.
Definition of microbiological cure:
Elimination of the relevant pathogen(s) at the relevant site(s) of infection (at least one negative culture) or
in case "no sample available/indicated due to sufficient clinical response", pathogen elimination is considered.
Time Frame:
Defined to be after end of hospital stay + within 1 year after start of fosfomycin treatment. Either the latest visit after "End of hospital stay" within 1 year after start of fosfomycin treatment or, if applicable, the visit in this time frame assessing a clinical failure/relapse.
measure: Sodium serum levels
time frame: On every day from start of fosfomycin treatment until end of hospital stay (up to 6 months after start of fosfomycin treatment)
measure: Potassium serum levels
time frame: On every day from start of fosfomycin treatment until end of hospital stay (up to 6 months after start of fosfomycin treatment)
measure: Adverse events
time frame: On every day from start of fosfomycin treatment until end of follow-up (up to one year after start of fosfomycin treatment)
measure: Non-serious adverse events
time frame: On every day from start of fosfomycin treatment until end of follow-up (up to one year after start of fosfomycin treatment)
measure: Serious adverse events
time frame: On every day from start of fosfomycin treatment until end of follow-up (up to one year after start of fosfomycin treatment)
measure: Cases of death
time frame: On every day from start of fosfomycin treatment until end of follow-up (up to one year after start of fosfomycin treatment)
measure: Adverse drug reactions (ADRs)
time frame: On every day from start of fosfomycin treatment until end of follow-up (up to one year after start of fosfomycin treatment)
measure: Serious adverse drug reactions (SADRs)
time frame: On every day from start of fosfomycin treatment until end of follow-up (up to one year after start of fosfomycin treatment)
measure: Dropouts due to treatment failure or due to adverse events
time frame: On every day from start of fosfomycin treatment until end of follow-up (up to one year after start of fosfomycin treatment)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Klaus-Friedrich Bodmann, Dr.
role: Study Director
affiliation: Klinik Nordoberpfalz AG, Klinikum Weiden
last name: Thomas Borrmann, Dr.
email: studien@infectopharm.com
last name: Katja Eifert
email: studien@infectopharm.com
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Active, not recruiting
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Active, not recruiting
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: Austria
country: Germany
country: Greece
country: Italy
country: United Kingdom
responsible party type: Sponsor
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Pneumonia
mesh term: Urinary Tract Infections
mesh term: Respiratory Tract Infections
mesh term: Bacterial Infections
mesh term: Bacteremia
mesh term: Abscess
mesh term: Osteomyelitis
mesh term: Soft Tissue Infections
mesh term: Pneumonia, Bacterial
mesh term: Intraabdominal Infections
mesh term: Skin Diseases, Bacterial
mesh term: Endocarditis, Bacterial
mesh term: Meningitis, Bacterial
mesh term: Brain Abscess
mesh term: Bone Diseases, Infectious
mesh term: Central Nervous System Bacterial Infections
mesh term: Bone Diseases
mesh term: Meningitis
mesh term: Encephalitis
mesh term: Endocarditis
mesh term: Skin Diseases