<?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>IRCT2014123020485N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2015-05-25</date_registration>
      <primary_sponsor>Ahvaz Jundishapour Medical University</primary_sponsor>
      <public_title>Evaluation of efficacy of prophylactic antibiotic therapy in prevention of incidence of meningitis in patient with basilar skull fracture and cerebrospinal fluid  leakage</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of efficacy of prophylactic antibiotic therapy in prevention of incidence of meningitis in patient with basilar skull fracture and cerebrospinal fluid leakage in traumatic patient reffer to golestan hospital of ahvaz in 2014-2015</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2015-02-08</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>346</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/18164</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Fracture of base of skull due to trauma.</hc_freetext>
      <i_freetext>Intervention 1: Approximately 178 patients with CSF leak following base skull fractures were selected. For prophylaxis, two Cotrimoxazole tablets (400/80 miligram) and three Amoxicillin capsules (500 miligram) were administered daily. Intervention 2: In the control group, placebo drugs with complete resemblance to the actual drugs were given to patients (two Cotrimoxazole placebo tablets and three Amoxicillin placebo capsules, daily). The placebo drugs were provided by Ahvaz Jundishapour Medical Universities School of Pharmacy.</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>Dr Hasan Akbardokht</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Neurosergery ward-Ahvaz Golestan Hospital</address>
        <city>ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>61357-15749</zip>
        <telephone>+98 61 3374 3032</telephone>
        <email>akbardokht@yahoo.com</email>
        <affiliation>Ahvaz Jundishapour Medical Sciences University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Hasan Akbardokht</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Neyrosegery ward-Ahvaz Golestan Hospital</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>61357-15749</zip>
        <telephone>+98 61 3374 3032</telephone>
        <email>akbardokht2yahoo.com</email>
        <affiliation>Ahvaz Jundishapour Medical Sciences University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>(Inclusion criteria:Selected patients suffered from traumatic base skull fractures with cerebrospinal fluid leakage characterized by rhinorrhea or otorrhea;All participants were at least 18 years old)&#13;
(Exclusion criteria: Patients with visible lesions on CT scans in need of surgery;patient with Depressed skull fracture, space-occupying lesions, signs of intracranial pressure increase;patients with cerebrospinal fluid disturbance and/ or meningitis; In cases with signs of meningitis such as fever, purulent discharge, meningismus)</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>80 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>S02.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Fracture of base of skull</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Approximately 178 patients with CSF leak following base skull fractures were selected. For prophylaxis, two Cotrimoxazole tablets (400/80 miligram) and three Amoxicillin capsules (500 miligram) were administered daily.</i_keyword>
      <i_keyword>In the control group, placebo drugs with complete resemblance to the actual drugs were given to patients (two Cotrimoxazole placebo tablets and three Amoxicillin placebo capsules, daily). The placebo drugs were provided by Ahvaz Jundishapour Medical Universities School of Pharmacy.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Prevention of incidence of meningitis in patient with basilar skull fracture and csf leakage. Timepoint: TBI patient reffer to Golestan hospital of ahvaz in 2014-2015. Method of measurement: Analyse of csf obtain frome lumbar puncture.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Incidence of meningitis. Timepoint: in course of admision. Method of measurement: with lumbar puncture  and analyse of  cerebrospinal fuid  sample.</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>Ahvaz Jundishapour Medical University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-02-07</approval_date>
        <contact_name>Ahvaz Jondi Shapour  University of Medical Sciences</contact_name>
        <contact_address>Ahvaz medical science university-Golestan-Ahvaz Ahvaz  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
