<?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>IRCT2017010331737N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-02-24</date_registration>
      <primary_sponsor>Arak University of Medical Sciences</primary_sponsor>
      <public_title>Use of Procalcitonin in therapy of Pneumonia</public_title>
      <acronym></acronym>
      <scientific_title>Clinical trial for evaluation of effect of procalcitonin-based algorithm in duration of antibiotic therapy and hospitalization of community acquired  pneumonia and chronic obstructive pulmonary disease exacerbation</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2015-05-12</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>140</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/24903</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Chronic obstructive pulmonary disease. Condition 2: Pneumonia.</hc_freetext>
      <i_freetext>Intervention 1: In the case group, the antibiotic therapy is guided by serum procalcitonin. In this group, the patients are classified into four groups, according to the procalcitonin algorithm that is validated in previous studies. A procalcitonin level of less than 0.1g/L suggested the absence of bacterial infection and the initiation or continuation of antibiotics is strongly discouraged. A procalcitonin level between 0.1 and 0.25 g/L indicated that bacterial infection is unlikely, and the initiation or continuation of antibiotics is discouraged. A procalcitonin level from 0.25 to 0.5 g/L is considered to indicate a possible bacterial infection and the initiation or continuation of antibiotic therapy is encouraged. A procalcitonin level greater than 0.5 g/L strongly suggested the presence of bacterial infection and antibiotic treatment and continuation is strongly encouraged. Reassessment of procalcitonin is done in procalcitonin group at 3, 5, and 7 days if antibiotic therapy initiated and antibiotics are discontinued on the cutoffs defined above. Intervention 2: In the control group, the antibiotic therapy is chosen on the basis of usual practice guidelines.</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>Naghmeh Arkan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Infectious Disease Department, Valiasr Hospital, Valiasr Square, Arak</address>
        <city>Arak</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 86 3224 1411</telephone>
        <email>n.arkan@arakmu.ac.ir</email>
        <affiliation>School of Medicine, Arak University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Naghmeh Arkan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Infectious Diseases Departmnet, Valiasr Hospital, Valiasr Square, Arak</address>
        <city>Arak</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 86 3224 1411</telephone>
        <email>n.arkan@arakmu.ac.ir</email>
        <affiliation>School of Medicine, Arak University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria:&#13;
Patients to be at least 18 years; with diagnosis of Community Acquired Pneumonia ( CAP ) or Chronic Obstructive Pulmonary Disease ( COPD ) exacerbation; with at least one respiratory symptom ( cough, sputum, dyspnea, tachypnea, pleuretic chest pain ); in addition to at least one respiratory sign on auscultation (rales,cripitation); or one infection indicator ( T greater than 38 c, chills, WBC less than 4000 or greater than 10000 per milliliter ); hospitalized in Infectious ward of Arak Valiasr University Hospital. &#13;
Exclusion criteria:&#13;
Patients that can't consent voluntary; active IV drug users; severe immunosuppression ( except use of corticosteroid ); severe comorbidity; patients with hospital- acquired pneumonia ( pneumonia presented at 48 hours after hospitalization or previous history of hospitalization during 14 days before this admission ); patients requiring antibiotic therapy for chronic infection.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>100 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>J44.1</hc_code>
      <hc_code>J18.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Chronic obstructive pulmonary disease with acute exacerbation, unspecified</hc_keyword>
      <hc_keyword>Pneumonia, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In the case group, the antibiotic therapy is guided by serum procalcitonin. In this group, the patients are classified into four groups, according to the procalcitonin algorithm that is validated in previous studies. A procalcitonin level of less than 0.1g/L suggested the absence of bacterial infection and the initiation or continuation of antibiotics is strongly discouraged. A procalcitonin level between 0.1 and 0.25 g/L indicated that bacterial infection is unlikely, and the initiation or continuation of antibiotics is discouraged. A procalcitonin level from 0.25 to 0.5 g/L is considered to indicate a possible bacterial infection and the initiation or continuation of antibiotic therapy is encouraged. A procalcitonin level greater than 0.5 g/L strongly suggested the presence of bacterial infection and antibiotic treatment and continuation is strongly encouraged. Reassessment of procalcitonin is done in procalcitonin group at 3, 5, and 7 days if antibiotic therapy initiated and antibiotics are discontinued on the cutoffs defined above.</i_keyword>
      <i_keyword>In the control group, the antibiotic therapy is chosen on the basis of usual practice guidelines.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Duration of hospitalization. Timepoint: 14 days after intervention. Method of measurement: day.</prim_outcome>
      <prim_outcome>Duration of treatment. Timepoint: 14 days after intervention. Method of measurement: day.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Clinical Results. Timepoint: 3, 5, 7, 14 days after intervention. Method of measurement: Clinical assessment.</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>Arak University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-05-11</approval_date>
        <contact_name>Arak University of Medical Sciences</contact_name>
        <contact_address>A'lam-Al-Hoda Street, Shahid Shiroodi Street, Arak, Markazi Province, Iran Arak  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
