<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/NCT03280004</url>
  </required_header>
  <id_info>
    <org_study_id>HS-1279</org_study_id>
    <nct_id>NCT03280004</nct_id>
  </id_info>
  <brief_title>Reason Evaluation of Initial Treatment Failure in Patients With CAP</brief_title>
  <acronym>RECAP</acronym>
  <official_title>Reason Evaluation of Initial Treatment Failure in Patients With Community Acquired Pneumonia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peking Union Medical College Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Peking Union Medical College Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This research is to evaluate the effect of different antibiotics (Moxifloxacin Hydrochloride&#xD;
      and Sodium Chloride Injection vs. β-lactam antibiotics for injection +/- Azithromycin for&#xD;
      Injection) on the early deterioration or progression (&lt;72 h of treatment) of community&#xD;
      acquired pneumonia and to study the effect of the early deterioration or progression on the&#xD;
      prognosis of community acquired pneumonia.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">November 20, 2017</start_date>
  <completion_date type="Anticipated">November 30, 2019</completion_date>
  <primary_completion_date type="Anticipated">August 31, 2019</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>30 Days</target_duration>
  <primary_outcome>
    <measure>early deterioration or progression rate</measure>
    <time_frame>3 days</time_frame>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">314</enrollment>
  <condition>Community-acquired Pneumonia</condition>
  <arm_group>
    <arm_group_label>Moxifloxacin group</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>β-lactams group</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Moxifloxacin Hydrochloride and Sodium Chloride Injection</intervention_name>
    <description>Moxifloxacin group will be given Moxifloxacin Hydrochloride and Sodium Chloride Injection and β-lactams group will be given β-lactam antibiotics for injection +/- Azithromycin for Injection.</description>
    <arm_group_label>Moxifloxacin group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All patients in the 17 centers of the study who meet the inclusion and exclusion criteria&#xD;
        will be included.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age&gt;=18y.&#xD;
&#xD;
          2. Diagnosed with CAP.&#xD;
&#xD;
          3. Need hospitalization.&#xD;
&#xD;
          4. Receive Moxifloxacin Hydrochloride and Sodium Chloride Injection or β-lactam&#xD;
             antibiotics for injection +/- Azithromycin for Injection as initial treatment.&#xD;
&#xD;
          5. Signed informed consent form.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Patients who meet any of the following criteria will not be included in the study:&#xD;
&#xD;
          1. Pneumonia is aquired more than 48h after admission or the patient was admitted to&#xD;
             hospital within 30 days prior to admission.&#xD;
&#xD;
          2. Start antibiotic treatment before admission.&#xD;
&#xD;
          3. Gestational period or suckling period.&#xD;
&#xD;
          4. Admitted to ICU.&#xD;
&#xD;
          5. Immunocompromised patients.&#xD;
&#xD;
          6. Pneumonia is the terminal event of a serious disease.&#xD;
&#xD;
          7. Tuberculosis, lung cancer, non-infectious interstitial lung disease, pulmonary edema,&#xD;
             atelectasis, pulmonary embolism, pulmanory eosinophilia, pulmonary vasculitis.&#xD;
&#xD;
          8. Allergic to the antibiotics of the study.&#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>Xuezhong Yu, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Peking Union Medical College Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jun Xu, MD</last_name>
    <phone>010-69159142</phone>
    <email>xujunfree@126.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Jun Xu</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100730</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jun Xu, MD</last_name>
      <phone>01069159142</phone>
      <phone_ext>01069159142</phone_ext>
      <email>xujunfree@126.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>September 10, 2017</study_first_submitted>
  <study_first_submitted_qc>September 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 12, 2017</study_first_posted>
  <last_update_submitted>April 26, 2019</last_update_submitted>
  <last_update_submitted_qc>April 26, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 29, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Peking Union Medical College Hospital</investigator_affiliation>
    <investigator_full_name>Jun Xu</investigator_full_name>
    <investigator_title>Dr</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pneumonia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Moxifloxacin</mesh_term>
    <mesh_term>Norgestimate, ethinyl estradiol drug combination</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03280004
org study id: HS-1279
nct id: NCT03280004
lead sponsor: 
is fda regulated drug: Yes
is fda regulated device: No
This research is to evaluate the effect of different antibiotics (Moxifloxacin Hydrochloride
      and Sodium Chloride Injection vs. β-lactam antibiotics for injection +/- Azithromycin for
      Injection) on the early deterioration or progression (<72 h of treatment) of community
      acquired pneumonia and to study the effect of the early deterioration or progression on the
      prognosis of community acquired pneumonia.
observational model: Cohort
time perspective: Prospective
measure: early deterioration or progression rate
time frame: 3 days
arm group label: Moxifloxacin group
arm group label: β-lactams group
intervention type: Drug
intervention name: Moxifloxacin Hydrochloride and Sodium Chloride Injection
description: Moxifloxacin group will be given Moxifloxacin Hydrochloride and Sodium Chloride Injection and β-lactams group will be given β-lactam antibiotics for injection +/- Azithromycin for Injection.
arm group label: Moxifloxacin group
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Xuezhong Yu, MD
role: Principal Investigator
affiliation: Peking Union Medical College Hospital
last name: Jun Xu, MD
phone: 010-69159142
email: xujunfree@126.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Peking Union Medical College Hospital
investigator full name: Jun Xu
investigator title: Dr
mesh term: Pneumonia
mesh term: Moxifloxacin
mesh term: Norgestimate, ethinyl estradiol drug combination
sharing ipd: No