<?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>IRCT20171230038142N11</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-02-19</date_registration>
      <primary_sponsor>Esfahan University of Medical Sciences</primary_sponsor>
      <public_title>Comparing nebulized colistin with nebulized Tobramycin- Fosfomycin as an adjunctive treatment of ventilator associated pneumonia due to multi drug resistant acinetobacter</public_title>
      <acronym></acronym>
      <scientific_title>Comparing nebulized colistin with nebulized Tobramycin- Fosfomycin as an adjunctive treatment of ventilator associated pneumonia due to multi drug resistant acinetobacter</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-08-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/45788</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients are first conveniently and easily selected from the list of patients with ventilator pneumonia admitted to the ICU center of Alzahra Hospital in Isfahan and then divided into two groups of 30 each using double blocks, Blinding description: Patients admitted to the ICU are not aware of the therapeutic content and the data analyzer has no information about the name and other characteristics of the patients.</study_design>
      <phase>2-3</phase>
      <hc_freetext>ventilator associated pneumonia due to multi drug resistant acinetobacter.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The inhaled tobramycin + phosphomycin treatment group (treated with intravenous meropenem and clistine) included 30 patients with ventilator-associated pneumonia, whose response to cultures of severely resistant acinetobacter baumannii was noted, among patients admitted to the intensive care unit of Alzahra Hospital. Phosphomycin solution with 4% concentration (2 ml of this solution, 80 mg proportion) is introduced into the nebulizer jet chamber for patient use. This is accomplished by filtration using 100 nm filters at the appropriate pH (about 7) and with the appropriate tonicity of body fluids that do not cause irritation when inhaled. The Clinical Pulmonary Infection Score (CPIS) criterion is used to diagnose ventilator pneumonia. The criterion consists of 5 sections, each with a score of 0 to 2, and patients score between 0 and 10. Intervention 2: Intervention group: Intervention group: Inhaled clistine treatment group (treated with meropenem and intravenous clistine), including 30 patients with ventilator pneumonia, whose response to cultures of highly resistant acinetobacter baumannii was noted, was selected from patients in the intensive care units of Al-Zahra Hospital. Ventilator pneumonia diagnosis is used by the Clinical Pulmonary Infection Score (CPIS). The criterion consists of 5 sections each with a score of 0 to 2, and patients score between 0 and 10.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
The information is shared two years after the results are published.

When:
The information is shared two years after the results are published.

To whom:
Doctors and Infectious Diseases

Conditions:
Compare information available with other medications or other therapies

Where to obtain:
Email a.hakamifard@med.mui.ac.ir and obtain permission from Isfahan University of Medical Sciences

How to obtain:
Email a.hakamifard@med.mui.ac.ir and obtain permission from Isfahan University of Medical Sciences

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Atusa Hakami Fafd</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Al-Zahra Hospital, Sofah Boulevard.</address>
        <city>Esfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>81746-73461</zip>
        <telephone>+98 31 3668 0048</telephone>
        <email>a.hakamifard@med.mui.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Atusa Hakami Fafd</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Al-Zahra Hospital, Sofah Boulevard.</address>
        <city>Esfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>81746-73461</zip>
        <telephone>+98 31 3668 0048</telephone>
        <email>a.hakamifard@med.mui.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patient hospitalization in ICU
Ages between 20 and 65
Diagnosis of ventilator pneumonia for the patient
Diagnosis of cholesterol-sensitive Acinetobacter baumannii
Patient satisfaction</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Diagnosis Another concomitant disease
Start treatment of acinetobacter
The patient died before the response</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>J95.851</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Ventilator associated pneumonia</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: The inhaled tobramycin + phosphomycin treatment group (treated with intravenous meropenem and clistine) included 30 patients with ventilator-associated pneumonia, whose response to cultures of severely resistant acinetobacter baumannii was noted, among patients admitted to the intensive care unit of Alzahra Hospital. Phosphomycin solution with 4% concentration (2 ml of this solution, 80 mg proportion) is introduced into the nebulizer jet chamber for patient use. This is accomplished by filtration using 100 nm filters at the appropriate pH (about 7) and with the appropriate tonicity of body fluids that do not cause irritation when inhaled. The Clinical Pulmonary Infection Score (CPIS) criterion is used to diagnose ventilator pneumonia. The criterion consists of 5 sections, each with a score of 0 to 2, and patients score between 0 and 10.</i_keyword>
      <i_keyword>Intervention group: Intervention group: Inhaled clistine treatment group (treated with meropenem and intravenous clistine), including 30 patients with ventilator pneumonia, whose response to cultures of highly resistant acinetobacter baumannii was noted, was selected from patients in the intensive care units of Al-Zahra Hospital. Ventilator pneumonia diagnosis is used by the Clinical Pulmonary Infection Score (CPIS). The criterion consists of 5 sections each with a score of 0 to 2, and patients score between 0 and 10.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Mortality rates. Timepoint: After completing the study. Method of measurement: Counting the number of patients.</prim_outcome>
      <prim_outcome>Duration of response to treatment. Timepoint: After completing the study. Method of measurement: Counting the number of days admitted and the number of patients saved.</prim_outcome>
      <prim_outcome>CPIS index. Timepoint: Before and after treatment. Method of measurement: questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></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>Esfahan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-06-02</approval_date>
        <contact_name>Ethics Committee of Isfahan University of Medical Sciences</contact_name>
        <contact_address>Isfahan University of Medical Sciences, Hezar Jarib Ave. Isfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
