<?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>IRCT20170417033483N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-02-13</date_registration>
      <primary_sponsor>Kurdistan university of Medical Sciences</primary_sponsor>
      <public_title>Comparison the effect of two days interval amikacin with standard therapy in treatment of urinary tract infection</public_title>
      <acronym></acronym>
      <scientific_title>Comparison the effect of two days interval amikacin with standard therapy in treatment of urinary tract infection</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-05-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>200</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/25810</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients with inclusion criteria are randomly assigned to blocks of 20 in one of the two new treatment groups and the two control groups (routine treatment), Blinding description: After determining the treatment group, the treatment is given to each group based on the protocol (one group of moropenem and one group of amikacin). The drug is administered via micro-nutrition. The new treatment group receives 48 hours of amikacin at 3mg / kg / Q48 hours. The control group receives 1 μg / TDS of morophen every 8 hours. Blind for each group is injected through the microscope at intervals of 8 hours, in the intervention group, additional injections contain distilled water, which is poured into normal saline containing microscope. Medicines are placed in the patient basket by category. And the nurse will run the daily basket in accordance with its instructions. Given that the assessor, the laboratory and patient are not aware of any grouping.</study_design>
      <phase>3</phase>
      <hc_freetext>UTI.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group ESBL: Each 48 hours of amikacin is given 3mg / kg / Q48 hours for 7 days, and then treatment of Ofloxacin 300 mg twice daily for 7 days is continued. Intervention 2: ESBL control group: INn ESBL control group patients Maropenem is given at a dose of 1 g three times a day for one week, followed by treatment with ofloxacin 300 mg twice daily for 7 days. Intervention 3: Control group NON ESBL: In non-ESBL control group patients Maropenem is given at a dose of 1 g three times a day for one week, followed by treatment with ofloxacin 300 mg twice daily for 7 days. Intervention 4: Non ESBL intervention group: Each 48 hours of amikacin is given 3mg / kg / Q72 hours for 7 days, then treatment with ofloxacin 300 mg twice daily for 7 days.</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></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>hero azizzadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kurdistan University of Medical Sciences, pasdararn street , Sanandaj</address>
        <city>sanandaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>666147 - 13446</zip>
        <telephone>+98 87 3366 4645</telephone>
        <email>h.azizzadeh@muk.ac</email>
        <affiliation>Kurdistan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr.behzad mohsenpour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kurdistan University of Medical Sciences, Pasdaran Boulevard, Sanandaj, Kurdistan</address>
        <city>sanandaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>666147 - 13446</zip>
        <telephone>+98 87 3366 4645</telephone>
        <email>behzadmohsenpour@yahoo.com</email>
        <affiliation>kurdistan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients with symptoms of burning up urine
Patients with frequent urinary symptoms
Patients with urinary symptoms and fever</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Use of antibiotics over the last week
Stage I and above CKD
pregnancy
septic shock
use of immuno suppressive drugs
Increased patient creatinine by more than 3 or more than 50% relative to the original creatinine during treatment</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N39</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Urinary tract infection, site not specified</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>Intervention group ESBL: Each 48 hours of amikacin is given 3mg / kg / Q48 hours for 7 days, and then treatment of Ofloxacin 300 mg twice daily for 7 days is continued.</i_keyword>
      <i_keyword>ESBL control group: INn ESBL control group patients Maropenem is given at a dose of 1 g three times a day for one week, followed by treatment with ofloxacin 300 mg twice daily for 7 days.</i_keyword>
      <i_keyword>Control group NON ESBL: In non-ESBL control group patients Maropenem is given at a dose of 1 g three times a day for one week, followed by treatment with ofloxacin 300 mg twice daily for 7 days.</i_keyword>
      <i_keyword>Non ESBL intervention group: Each 48 hours of amikacin is given 3mg / kg / Q72 hours for 7 days, then treatment with ofloxacin 300 mg twice daily for 7 days.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Urinary tract infection(UTI). Timepoint: 7 days after the start of treatment, intravenous and oral treatment phase (7 days. Method of measurement: Urine analysis and urina culture.</prim_outcome>
      <prim_outcome>Clinical symptoms of UTI. Timepoint: 48 hours and 1 week after the end of therapy with intravenous and oral treatment. Method of measurement: By patient symptoms and clinical findings.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Adverse Drug Reactions. Timepoint: 48 hours and 1 week after treatment and at the end of intravenous and oral treatment. Method of measurement: Clinical symptoms and examination findings, laboratory.</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>Kurdistan university of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-10-30</approval_date>
        <contact_name>University of Kurdestan Medical Sciences, Faculty of Medicine</contact_name>
        <contact_address>Sanandaj, Kurdistan-Kurdistan-Iran Iranian Revolutionary Guards University of Medical Sciences sanandaj Kurdistan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
