<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01716260</url>
  </required_header>
  <id_info>
    <org_study_id>Bhutan_APMEN_CQ PQ_2013</org_study_id>
    <nct_id>NCT01716260</nct_id>
  </id_info>
  <brief_title>Safety and Efficacy of Chloroquine and Primaquine for Vivax Malaria in Bhutan</brief_title>
  <official_title>Parasitic Clearance and Recurrence Rates Among Patients With Vivax Malaria on Chloroquine and Primaquine Therapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Menzies School of Health Research</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ministry of Health, Bhutan</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Menzies School of Health Research</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This research is intended to study the efficacy of chloroquine (CQ) and primaquine (PQ) for&#xD;
      Plasmodium vivax (P.vivax) infection, and also to study the recurrence rate among patients&#xD;
      with P.vivax malaria on standard doses of CQ and PQ. For this study, PQ will be withheld for&#xD;
      28 days so as to study the efficacy of CQ alone.&#xD;
&#xD;
      This study will assess whether CQ is still effective against P.vivax or whether there are&#xD;
      resistant P.vivax strains in Bhutan.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study aims to assess the efficacy of Chloroquine alone, withholding Primaquine until day&#xD;
      28. Parasitic clearance and recurrence rates will be recorded. Patients whose blood stage of&#xD;
      parasites are not cleared with the standard dose of Chloroquine, or any recurrences before&#xD;
      day 28, will be treated with second line treatment (ACT).&#xD;
&#xD;
      The patients blood level of Chloroquine (drug concentration) at the time of a recrudescent&#xD;
      infection will de determined to assess whether that could be due to resistance, or due to low&#xD;
      level of Chloroquine.&#xD;
&#xD;
      Any relapses occurring after day 28 when not receiving Primaquine, or after completion of&#xD;
      Primaquine dosage for a total of 14 days (from day 29 to 42), will be treated with repeat&#xD;
      doses of the initial treatment. The recurrence rates will be recorded so as to develop the&#xD;
      next phase of the study where the two different doses of Primaquine (high dose vs. low dose)&#xD;
      will be compared.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2013</start_date>
  <completion_date type="Actual">October 2015</completion_date>
  <primary_completion_date type="Actual">October 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Chloroquine efficacy for P.vivax infections in Bhutan.</measure>
    <time_frame>28 days</time_frame>
    <description>The purpose is to study the efficacy of Chloroquine alone by recording recrudescent rates and parasitic clearance in P.vivax patients who are given a standard dose of Chloroquine treatment.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>To study the efficacy of Primaquine.</measure>
    <time_frame>Patients with recurrence after day 28 will be recorded.</time_frame>
    <description>In this study, Primaquine will be administered on day 28, and any relapse will be recorded to study relapse rates over a 12 month period.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>To assess the feasibility of a 12 month follow-up of patients with vivax malaria in Bhutan.</measure>
    <time_frame>12 months</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>To assess the safety of the currently prescribed CQ and PQ regimens in Bhutan.</measure>
    <time_frame>12 months</time_frame>
  </other_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">24</enrollment>
  <condition>Vivax Malaria</condition>
  <arm_group>
    <arm_group_label>Chloroquine and Primaquine</arm_group_label>
    <description>Chloroquine (CQ)10mg/kg for day 1, 2 and 5mg/kg for day 3 Primaquine (PQ)0.25mg/kg/day for 14 days</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Chloroquine</intervention_name>
    <arm_group_label>Chloroquine and Primaquine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Primaquine</intervention_name>
    <arm_group_label>Chloroquine and Primaquine</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with P.vivax infections will be recruited from 6 sentinel sites and will be&#xD;
        recruited for the study after informed consent is received.&#xD;
&#xD;
        An amendment has been approved to extend the study to 12 sites.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  &gt;12 months of age&#xD;
&#xD;
          -  infection with P.vivax parasitaemia monoinfection&#xD;
&#xD;
          -  presence of axillary temperature &gt;37.5 degrees or history of fever during the past 24&#xD;
             hours&#xD;
&#xD;
          -  ability to swallow oral medication&#xD;
&#xD;
          -  ability and willingness to comply with the study protocol for the duration of the&#xD;
             study, including 12 months follow up&#xD;
&#xD;
          -  informed consent from the patient/parent/guardian in the case of children&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Presence of general danger signs in children aged under 5 years or signs of severe&#xD;
             malaria according to the definitions of WHO&#xD;
&#xD;
          -  Presence of severe malnutrition (defined as a child whose growth standard is below -3&#xD;
             z-score, has symmetrical oedema involving at least the feet or has a mid-upper arm&#xD;
             circumference &lt; 110 mm);&#xD;
&#xD;
          -  History of haemolysis or severe anaemia&#xD;
&#xD;
          -  Acute anaemia &lt;7 mg/dL&#xD;
&#xD;
          -  Presence of febrile conditions due to diseases other than malaria (e.g. measles, acute&#xD;
             lower respiratory tract infection, severe diarrhoea with dehydration) or other known&#xD;
             underlying chronic or severe diseases (e.g. cardiac, renal and hepatic diseases,&#xD;
             HIV/AIDS);&#xD;
&#xD;
          -  Regular medication, which may interfere with antimalarial pharmacokinetics&#xD;
&#xD;
          -  History of hypersensitivity reactions or contraindications to any of the medicine(s)&#xD;
             being tested or used as alternative treatment(s)&#xD;
&#xD;
          -  a positive pregnancy test or lactating&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Year</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Vector Diseases Control Program</name>
      <address>
        <city>Gelephu</city>
        <country>Bhutan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Bhutan</country>
  </location_countries>
  <verification_date>April 2015</verification_date>
  <study_first_submitted>October 25, 2012</study_first_submitted>
  <study_first_submitted_qc>October 26, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 29, 2012</study_first_posted>
  <last_update_submitted>May 26, 2016</last_update_submitted>
  <last_update_submitted_qc>May 26, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 27, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Malaria</mesh_term>
    <mesh_term>Malaria, Vivax</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chloroquine</mesh_term>
    <mesh_term>Primaquine</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01716260
org study id: Bhutan_APMEN_CQ PQ_2013
nct id: NCT01716260
lead sponsor: 
collaborator: 
has dmc: Yes
This research is intended to study the efficacy of chloroquine (CQ) and primaquine (PQ) for
      Plasmodium vivax (P.vivax) infection, and also to study the recurrence rate among patients
      with P.vivax malaria on standard doses of CQ and PQ. For this study, PQ will be withheld for
      28 days so as to study the efficacy of CQ alone.

      This study will assess whether CQ is still effective against P.vivax or whether there are
      resistant P.vivax strains in Bhutan.
This study aims to assess the efficacy of Chloroquine alone, withholding Primaquine until day
      28. Parasitic clearance and recurrence rates will be recorded. Patients whose blood stage of
      parasites are not cleared with the standard dose of Chloroquine, or any recurrences before
      day 28, will be treated with second line treatment (ACT).

      The patients blood level of Chloroquine (drug concentration) at the time of a recrudescent
      infection will de determined to assess whether that could be due to resistance, or due to low
      level of Chloroquine.

      Any relapses occurring after day 28 when not receiving Primaquine, or after completion of
      Primaquine dosage for a total of 14 days (from day 29 to 42), will be treated with repeat
      doses of the initial treatment. The recurrence rates will be recorded so as to develop the
      next phase of the study where the two different doses of Primaquine (high dose vs. low dose)
      will be compared.
observational model: Cohort
time perspective: Prospective
measure: Chloroquine efficacy for P.vivax infections in Bhutan.
time frame: 28 days
description: The purpose is to study the efficacy of Chloroquine alone by recording recrudescent rates and parasitic clearance in P.vivax patients who are given a standard dose of Chloroquine treatment.
measure: To study the efficacy of Primaquine.
time frame: Patients with recurrence after day 28 will be recorded.
description: In this study, Primaquine will be administered on day 28, and any relapse will be recorded to study relapse rates over a 12 month period.
measure: To assess the feasibility of a 12 month follow-up of patients with vivax malaria in Bhutan.
time frame: 12 months
measure: To assess the safety of the currently prescribed CQ and PQ regimens in Bhutan.
time frame: 12 months
arm group label: Chloroquine and Primaquine
description: Chloroquine (CQ)10mg/kg for day 1, 2 and 5mg/kg for day 3 Primaquine (PQ)0.25mg/kg/day for 14 days
intervention type: Drug
intervention name: Chloroquine
arm group label: Chloroquine and Primaquine
intervention type: Drug
intervention name: Primaquine
arm group label: Chloroquine and Primaquine
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 1 Year
maximum age: N/A
healthy volunteers: No
facility: 
country: Bhutan
responsible party type: Sponsor
mesh term: Malaria
mesh term: Malaria, Vivax
mesh term: Chloroquine
mesh term: Primaquine