<?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>IRCT20200720048140N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-07-27</date_registration>
      <primary_sponsor>Kashan University of Medical Sciences</primary_sponsor>
      <public_title>The prevalence of antibiotic resistance in pediatrices  (3-15 years old)  with purulent sore throat</public_title>
      <acronym></acronym>
      <scientific_title>The prevalence of antibiotic resistance in pediatrices  (3-15 years old)  with streptococcal pharyngitis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-05-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>310</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/49758</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>2</phase>
      <hc_freetext>Streptococcal pharyngitis.</hc_freetext>
      <i_freetext>Intervention 1: Patients with positive culture, ie definite cases of streptococcal pharyngitis; Divided into 4 groups Intervention group 1: (Penicillin group) In this group of patients weighing less than 27 kg one dose of penicillin  6.3.3 muscle ampoule and Patients weighing more than 27 kg one dose of penicillin muscle ampoule 1.2 million units and 48 hours later re-culture and antibiogram were performed to evaluate antibiotic resistance.(Tri-Pen vial 6.3.3 and Benzapen vial 1,200,000 units). Intervention 2: Intervention group2 : azithromycin  group                                                     In this group, patients treated with suspension or azithromycin tablets with a dose of 12 mg per kg, single daily dose for 5 days.Then re-culture and antibiogram were performed to evaluate antibiotic resistance.(Azithromycin suspension 100 and 200 mg and tablets 250 and 500 mg from Farabi company). Intervention 3: Intervention group3: clindamycin group                                                         In this group, patients were treated with clindamycin at a dose of 7 mg per kg per dose, every 8 hours, for 10 days.Then re-culture and antibiogram were performed to evaluate antibiotic resistance.(Clindafarm capsules 150 and 300 mg). Intervention 4: Intervention group4: amoxicilin group   In this group, patients were treated with amoxicillin at a dose of 50 mg per kg daily, divided every 8 hours, for 10 days.Then re-culture and antibiogram were performed to evaluate antibiotic resistance.(Amoxicillin suspension 125 and 250 mg and capsules 250 and 500 mg from Farabi company).</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 Non-disclosure of patient information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>dr maryam shammaei zavareh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Qutb Ravandi Boulevard</address>
        <city>kashan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>87159-81151</zip>
        <telephone>0098315540026</telephone>
        <email>mary.zavare@yahoo.com</email>
        <affiliation>Kashan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>dr davood kheirkhah</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Qutb Ravandi Boulevard</address>
        <city>kashan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>87159-81151</zip>
        <telephone>+98 31 5554 0026</telephone>
        <email>drkheirkhah@yahoo.com</email>
        <affiliation>Kashan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>1- No history of tonsillectomy
No antibiotics in the last two weeks
Absence of complaints and symptoms of upper respiratory infection (cough, sneezing and runny nose)
Justification of the patient or his family and patients' desire to participate in the study</inclusion_criteria>
      <agemin>3 years</agemin>
      <agemax>15 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Age under 3 or over 15 years</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>J02.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Streptococcal pharyngitis</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Patients with positive culture, ie definite cases of streptococcal pharyngitis; Divided into 4 groups Intervention group 1: (Penicillin group) In this group of patients weighing less than 27 kg one dose of penicillin  6.3.3 muscle ampoule and Patients weighing more than 27 kg one dose of penicillin muscle ampoule 1.2 million units and 48 hours later re-culture and antibiogram were performed to evaluate antibiotic resistance.(Tri-Pen vial 6.3.3 and Benzapen vial 1,200,000 units)</i_keyword>
      <i_keyword>Intervention group2 : azithromycin  group                                                     In this group, patients treated with suspension or azithromycin tablets with a dose of 12 mg per kg, single daily dose for 5 days.Then re-culture and antibiogram were performed to evaluate antibiotic resistance.(Azithromycin suspension 100 and 200 mg and tablets 250 and 500 mg from Farabi company)</i_keyword>
      <i_keyword>Intervention group3: clindamycin group                                                         In this group, patients were treated with clindamycin at a dose of 7 mg per kg per dose, every 8 hours, for 10 days.Then re-culture and antibiogram were performed to evaluate antibiotic resistance.(Clindafarm capsules 150 and 300 mg)</i_keyword>
      <i_keyword>Intervention group4: amoxicilin group   In this group, patients were treated with amoxicillin at a dose of 50 mg per kg daily, divided every 8 hours, for 10 days.Then re-culture and antibiogram were performed to evaluate antibiotic resistance.(Amoxicillin suspension 125 and 250 mg and capsules 250 and 500 mg from Farabi company)</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Throat culture. Timepoint: Throat culture at the beginning of the study and After prescribing antibiotics. Method of measurement: Swap and culture dish.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Antibiogram. Timepoint: After administration of antibiotics in positive culture cases. Method of measurement: Antibiotic disc.</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>Kashan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-05-21</approval_date>
        <contact_name>Ethics Committee of Kashan University of Medical Sciences</contact_name>
        <contact_address>Qutb Ravandi Boulevard kashan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
