<?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>IRCT20151227025726N9</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-08-15</date_registration>
      <primary_sponsor>Shahid Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>The Role of Aerosolized Colistin in the Treatment of Ventilator-associated Pneumonia, Caused by Multidrug-resistant Gram-negative Bacteria</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of Aerosolized (AS) Colistin as Adjunctive Treatment Versus Intravenous Colistin Alone in the Treatment of Ventilator-associated Pneumonia (VAP) Caused by Multidrug-resistant Gram-negative Bacteria</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-04-04</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>34</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/21471</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Blinding description: Investigator, outcome assessors, and data analyser were blind to the study groups untill the end of the study.</study_design>
      <phase>3</phase>
      <hc_freetext>Ventilator-associated Pneumonia (VAP).</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Received IV colistin (Colistimethate Sodium Injection, powder for solution parenteral 1000000 [IU] that belongs to Forest Laboratories Uk) based on Glomerular Filtration Rate (GFR) plus two million units of AS colistin , three times per day. Dose adjustments of IV Colistin were implemented based on table that belongs to Systematic review of the evidence for rational dosing of colistin. Prescribtion of IV colistin was countinued until the infection was completely resolved; AS colistin was prescribed only for a period of seven days (OMRON Mesh Nebulizer Model NE-U22). To prevent bronchospasm caused by nebulized colistin, patients were premedicated with salbutamol prior to administration of nebulized colistin. Intervention 2: Control group: Intravenous Colistin based on Glomerular Filtration Rate.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is There is no further information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Faezeh Feizabadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 2660, Vali-e Asr St., Niyayesh Junction, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>14155-6153</zip>
        <telephone>+98 21 2230 8287</telephone>
        <email>faezehfe@gmail.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Farzaneh Dastan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 2660, Vali-e Asr St., Niyayesh Junction, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>14155-6153</zip>
        <telephone>+98 21 8887 3704</telephone>
        <email>fzh.dastan@gmail.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age above 18 years
Antibiogram of positive culture that is sensitive to Colistin and resistant to all other antibiotics
The new continuous pulmonary secretions based on lung radiography among patients who are received mechanical ventilation for at least 48 hours
Fever above 38ºC without any specific reason
White Blood Cell number more than 12000 cells  or less than 4000 cells in each milliliter
Purulent tracheal secretions</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>100 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Pregnancy
Breastfeeding
Septic shock</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>J15</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Bacterial pneumonia, not elsewhere classified</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: Received IV colistin (Colistimethate Sodium Injection, powder for solution parenteral 1000000 [IU] that belongs to Forest Laboratories Uk) based on Glomerular Filtration Rate (GFR) plus two million units of AS colistin , three times per day. Dose adjustments of IV Colistin were implemented based on table that belongs to Systematic review of the evidence for rational dosing of colistin. Prescribtion of IV colistin was countinued until the infection was completely resolved; AS colistin was prescribed only for a period of seven days (OMRON Mesh Nebulizer Model NE-U22). To prevent bronchospasm caused by nebulized colistin, patients were premedicated with salbutamol prior to administration of nebulized colistin.</i_keyword>
      <i_keyword>Control group: Intravenous Colistin based on Glomerular Filtration Rate</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The correlation between antibiotic therapy initiation and the time of negative procalcitonin (PCT) test. Timepoint: Days of 0, 3, 5, 7 after antibiotic initiation. Method of measurement: Immunochromatographic test (PCT-Q).</prim_outcome>
      <prim_outcome>The correlation between antibiotic therapy initiation and the time of negative sputum culture. Timepoint: Days of 0, 4, 7 after antibiotic initiation. Method of measurement: Sputum culture.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Duration of ICU stay. Timepoint: Daily. Method of measurement: By the date of admission and discharge mentioned in Clinical records.</sec_outcome>
      <sec_outcome>Time of  fever discontinuation. Timepoint: Every other day. Method of measurement: Thermometer.</sec_outcome>
      <sec_outcome>The correlation between antibiotic therapy initiation and the reduction of WBC. Timepoint: Every other day. Method of measurement: Hematologic test.</sec_outcome>
      <sec_outcome>The correlation between antibiotic therapy initiation and improvement of PaO2/FiO2. Timepoint: Every other day. Method of measurement: By arterial and venous blood gasses (ABG and VBG).</sec_outcome>
      <sec_outcome>Chest X-Ray changes. Timepoint: Every other day. Method of measurement: By chest x-ray radiography.</sec_outcome>
      <sec_outcome>Improvement of Clinical Pulmonary Infection Score (CPIS). Timepoint: Every other day. Method of measurement: BY CPIS score.</sec_outcome>
      <sec_outcome>All the adverse effects associated with the use of colistin including bronchospasm, neurotoxicity, and hypersensitivity reactions. Timepoint: Daily. Method of measurement: Clinical records.</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>Research Committee, School of Pharmacy, Shahid Beheshti University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-03-01</approval_date>
        <contact_name>Ethics committee of School of Pharmacy, Nursing, and midwifery; Shahid Beheshti University of Medica</contact_name>
        <contact_address>No. 2660, Vali-e Asr St., Niyayesh Junction, Tehran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
