<?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>IRCT2013112015465N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2014-01-21</date_registration>
      <primary_sponsor>Shahid Beheshti Medical University, Faculty of Pharmacy</primary_sponsor>
      <public_title>Study of the Effect of N-acetylcysteine on Urinary Tract Infection in Children.</public_title>
      <acronym></acronym>
      <scientific_title>Study of the Effect of N-acetylcysteine Compared with Placebo on Inflammation Biomarkers of Acute Pyelonephritis in Children.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2014-01-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>64</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/14728</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: This study is a triple blind, placebo controlled trial. Patients,  prescriber, researcher and statistical analyzer are blind in this trial. The main drug and placebo are very similar in terms of appearance, odor, flavor,....So they are Indistinguishable from each other by patients or prescriber. Coding of drugs will be done by another person other than prescriber, researcher and statistical analyzer. Codes are numbers 1-64.</study_design>
      <phase>3</phase>
      <hc_freetext>Acute pyelonephritis.</hc_freetext>
      <i_freetext>Intervention 1: Effervescent tablet of N-acethyl cystein 600 mg &#13;
dosing according to weight, until 5 days. Dose for patients more than 30 kg: 1.5 tablet daily&#13;
8.5-30 kg: 1 tablet daily&#13;
less than 8.5 kg: 70 mg/kg. Intervention 2: Placebo effervescent tablet of N-acethyl cystein 600 mg &#13;
dosing according to weight, until 5 days. Dose for patients more than 30 kg: 1.5 tablet daily&#13;
8.5-30 kg: 1 tablet daily:&#13;
more than 30 kg: 1.5 tablet daily&#13;
8.5-30 kg: 1 tablet daily&#13;
less than 8.5 kg: 70 mg/kg.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Zahra Allameh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of pharmacy,lower than Niayesh intersection, Vali-asr street, Tehran, IR Iran.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 31 1273 6097</telephone>
        <email>Zahra_allameh@yahoo.comzahraallameh@gmail.com</email>
        <affiliation>Faculty of Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, IR Iran.</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Zahra Allameh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of pharmacy, Vali-asr street, lower than Niayesh intersection, Tehran, IR Iran.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 31 1273 6097</telephone>
        <email>zahra_allameh@yahoo.com</email>
        <affiliation>Faculty of pharmacy</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: Patients between the ages of 1 and 16; Having the diagnosis of "definite" or  "probable" urinary tract infection according to guidelines of "pediatric infectious disease research center".&#13;
Exclusion criteria: Patients younger than 1 or older than 16 years old; Patients without the diagnosis of "definite" or  "probable" urinary tract infection according to guidelines of "pediatric infectious disease research center"; Patients with acute/ chronic infectious or inflammatory diseases other than pyelonephritis.</inclusion_criteria>
      <agemin>1 year</agemin>
      <agemax>16 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N10</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Acute tubulo-interstitial nephritis</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>Effervescent tablet of N-acethyl cystein 600 mg &#13;
dosing according to weight, until 5 days. Dose for patients more than 30 kg: 1.5 tablet daily&#13;
8.5-30 kg: 1 tablet daily&#13;
less than 8.5 kg: 70 mg/kg</i_keyword>
      <i_keyword>Placebo effervescent tablet of N-acethyl cystein 600 mg &#13;
dosing according to weight, until 5 days. Dose for patients more than 30 kg: 1.5 tablet daily&#13;
8.5-30 kg: 1 tablet daily:&#13;
more than 30 kg: 1.5 tablet daily&#13;
8.5-30 kg: 1 tablet daily&#13;
less than 8.5 kg: 70 mg/kg</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Serum procalcitonin. Timepoint: Before giving drug, and 5 days after giving the drug. Method of measurement: Serum procalcitonin test.</prim_outcome>
      <prim_outcome>CRP. Timepoint: Before and 5 days after starting therapy. Method of measurement: Blood test.</prim_outcome>
      <prim_outcome>Leukocyte count. Timepoint: Before and 5 days after starting therapy. Method of measurement: Blood test.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Probable adverse effects (nausea, vomiting, bad tasting, stomatitis, ...). Timepoint: Daily. Method of measurement: Clinical examination and asking from patients.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name>Pediatric Infectious Research Center, Mofid Hospital</sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Shahid Beheshti Medical University, Faculty of Pharmacy</source_name>
      <source_name>Pediatric Infectious Research Center, Mofid Hospital</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2013-07-23</approval_date>
        <contact_name>Shahid Beheshti Medical University, Faculty of Pharmacy</contact_name>
        <contact_address>Vali-asr street Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
