<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20260619069864N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2026-09-08</date_registration>
      <primary_sponsor>sheikh zayed hospital</primary_sponsor>
      <public_title>Comparative Efficacy of Levofloxacin versus Ceftriaxone and Azithromycin for Treating Community Acquired Pneumonia</public_title>
      <acronym></acronym>
      <scientific_title>Comparative Efficacy of Levofloxacin versus Ceftriaxone and Azithromycin for Treating Community Acquired Pneumonia</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-12-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>150</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/91417</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Education/Guidance, Randomization description: Eligible participants who provide informed consent will be randomly allocated individually in a 1:1 ratio to either the levofloxacin group or the ceftriaxone plus azithromycin group. Simple randomization will be performed using a computer-generated random allocation sequence. The sequence will be generated before participant recruitment by an independent investigator who is not involved in recruitment or treatment. Sequentially numbered, opaque, sealed envelopes will be used for allocation concealment. After enrollment and baseline assessment, the next envelope in sequence will be opened to reveal the treatment assignment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Community Acquired Pnemonia.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Levofloxacin 750 mg intravenously once daily for 5 days. Intervention 2: Control group: Ceftriaxone 1 g intravenously twice daily plus azithromycin 500 mg intravenously once daily for 5 days.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is Deidentified individual participant data will not be shared because participant consent does not include unrestricted data sharing. To protect participant confidentiality and comply with institutional ethics requirements, there is no current plan to make the IPD publicly available.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>DR SUNDAS KANWAL</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>RAHIM YAR KHAN</address>
        <city>RAHIM YAR KHAN</city>
        <country1>Pakistan</country1>
        <zip>64200</zip>
        <telephone>+92 308 3606209</telephone>
        <email>sundask95@gmail.com</email>
        <affiliation>SHEIKH ZAYED HOSPITAL, RAHIM YAR KHAN</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>dr sundas kanwal</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>hospital road</address>
        <city>Rahim yar khan</city>
        <country1>Pakistan</country1>
        <zip>64200</zip>
        <telephone>+92 308 3606209</telephone>
        <email>sundask95@gmail.com</email>
        <affiliation>sheikh zayed hospital</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age 18-70 years.
All patients with a diagnosis of mild to moderate CAP as peroperational definitions that is CURB-65 score of 2 or less than 2 and having moderate severity according to APACHE II Score (APACHE score 11-20)
Both male and female patients.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Radiography pictures of patients with cystic fibrosis show signs of empyema.
individuals with HIV/AIDS
Individuals with a history of serious mental problems, seizures
Individuals with a history of drug allergies to the study's medications.
A lady who is nursing or pregnant.
Already on antibiotic therapy before admission for the current illness (more than 24 hours).</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>J18.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Pneumonia, unspecified organism</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Levofloxacin 750 mg intravenously once daily for 5 days.</i_keyword>
      <i_keyword>Control group: Ceftriaxone 1 g intravenously twice daily plus azithromycin 500 mg intravenously once daily for 5 days</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Oxygen saturation. Timepoint: 3rd and 5th Day of Hospital Admission. Method of measurement: clinical assessment.</prim_outcome>
      <prim_outcome>Length of hospital stay. Timepoint: At discharge. Method of measurement: Number of days from initiation of study treatment to hospital discharge, as recorded in the patient's hospital record.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Cough frequency and severity. Timepoint: Day 3 and Day 5 after initiation of treatment. Method of measurement: Patient-reported reduction in cough frequency and severity.</sec_outcome>
      <sec_outcome>Body temperature. Timepoint: Day 3 and Day 5 after initiation of treatment. Method of measurement: Measurement of body temperature using a standard clinical thermometer.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>sheikh zayed hospital</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2025-02-28</approval_date>
        <contact_name>Institutional Reveiw Board- Sheikh Zayed Medical College/Hospital</contact_name>
        <contact_address>Sheikh Zayed Medical College/ Hospital, Rahim Yar Khan Rahim Yar Khan Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
