<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/NCT01697787</url>
  </required_header>
  <id_info>
    <org_study_id>CM/CRUN0012</org_study_id>
    <nct_id>NCT01697787</nct_id>
  </id_info>
  <brief_title>Amodiaquine-Artesunate &amp; Artemether-Lumefantrine Efficacy in Burkina Faso</brief_title>
  <official_title>Efficacy of Amodiaquine-Artesunate (ASAQ) and Artemether-Lumefantrine (AL) for the Treatment of Uncomplicated Falciparum Malaria in Nanoro, Burkina Faso</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Muraz</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Institute of Tropical Medicine, Belgium</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Centre Muraz</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a two-arm study aiming at recruiting 150 patients to assess the efficacy of&#xD;
      Amodiaquine-Artesunate (ASAQ) and Artemether-Lumefantrine (AL) in patients with a microscopy&#xD;
      positive diagnosis of malaria in Nanoro, Burkina Faso and assess the performance of the Rapid&#xD;
      Diagnosis Tests (RDTs) compared to the microscopy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study background and purpose&#xD;
&#xD;
        -  Resistance to usual drugs was widespread and has required a change of the malaria&#xD;
           treatment by several countries&#xD;
&#xD;
        -  Several countries have changed their first-line treatments to ACTs; mainly AL and ASAQ.&#xD;
           &amp; have adopted the use of RDTs prior to treatment&#xD;
&#xD;
        -  Indeed, this contributes to decrease the number of unnecessary treatments and thus&#xD;
           improve the management of malaria cases.&#xD;
&#xD;
        -  In February 2005, Burkina Faso changed its national drug policy from Chloroquine to&#xD;
           Amodiaquine-Artesunate (ASAQ) and Artemether-Lumefantrine (AL)&#xD;
&#xD;
        -  the country has also implemented the strategy of using the Rapid Diagnosis Tests (RDTs)&#xD;
           for the diagnosis of malaria prior to treatment&#xD;
&#xD;
        -  Though endemic countries are being encouraged to implement RDTs, choosing a particular&#xD;
           RDT is not easy as several brands are available on the market.&#xD;
&#xD;
        -  In addition, little information on the performance of RDTs in Africa is available and&#xD;
           recently quality problems have been reported with some RDTs.&#xD;
&#xD;
        -  In this context, it is important to locally assess the performance of RDTs compared with&#xD;
           the microscopy, which is the gold standard for the malaria diagnosis and to assess the&#xD;
           efficacy of the new drugs used for malaria treatment&#xD;
&#xD;
      This is a phase IV two-arm randomized open-label study aiming at recruiting 150 patients to&#xD;
      assess the efficacy of ASAQ and AL in patients with a microscopy positive diagnosis of&#xD;
      malaria in Nanoro, Burkina Faso and assess the performance of the RDT compared to the&#xD;
      microscopy&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">September 2014</completion_date>
  <primary_completion_date type="Actual">September 2014</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Rate of treatment failures</measure>
    <time_frame>28 days</time_frame>
    <description>The rate of the two ACTs treatment failures at day 28: all treatment failures, both parasitological and clinical (positive blood slide at day 28)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>RDT performance Vs microscopy</measure>
    <time_frame>28 days</time_frame>
    <description>The proportion of discrepancies between the RDT and the microscopy results</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Fever clearance time (FCT) Fever Clearance Time</measure>
    <time_frame>28 days</time_frame>
    <description>Fever clearance time will be defined as the time (in days) from the time of the drug administration to the first two consecutive measurements on 2 different days of axillary temperature below 37.5°C</description>
  </other_outcome>
  <other_outcome>
    <measure>Gametocytes carriage</measure>
    <time_frame>28 days</time_frame>
    <description>Gametocytes carriage including the estimation of the prevalence and density</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">150</enrollment>
  <condition>Malaria</condition>
  <arm_group>
    <arm_group_label>Amodiaquine-Artesunate</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>ASAQ is produced by Sanofi-Aventis as CoarsucamTM and as artesunate-amodiaquine Winthrop®</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Artemether-Lumefantrine</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>AL (tablets containing 20 mg of artemether and 120 mg of lumefantrine) is produced by Novartis</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Amodiaquine-Artesunate</intervention_name>
    <description>If necessary, the study drug will be crushed, dissolved in water and squirted into the mouth using a spoonful. Administration of the treatments will be directly observed. After drug administration, patients will be kept for at least 30 minutes in the clinic. A dose will be repeated in full if vomiting occurs within 30 minutes of administration and halved if vomiting is between 30 minutes and 1 hour post dosing.</description>
    <arm_group_label>Amodiaquine-Artesunate</arm_group_label>
    <other_name>ASAQ Winthrop, Coarsucam</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Artemether-lumefantrine</intervention_name>
    <description>If necessary, the study drug will be crushed, dissolved in water and squirted into the mouth using a spoonful. Administration of the treatments will be directly observed. After drug administration, patients will be kept for at least 30 minutes in the clinic. A dose will be repeated in full if vomiting occurs within 30 minutes of administration and halved if vomiting is between 30 minutes and 1 hour post dosing.</description>
    <arm_group_label>Artemether-Lumefantrine</arm_group_label>
    <other_name>Coartem, Riamet</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age above 6 months,&#xD;
&#xD;
          -  eight above 5 kg;&#xD;
&#xD;
          -  Positive blood slide (parasitaemia ≥ 2,000/μL to 200,000/μL) with Plasmodium&#xD;
             falciparum monospecific infection ;&#xD;
&#xD;
          -  Fever (axillary temperature above 37.5 °C) or history of fever in the preceding 24&#xD;
             hours;&#xD;
&#xD;
          -  Haemoglobin value above or equal 5.0 g/dL&#xD;
&#xD;
          -  Signed informed consent;&#xD;
&#xD;
          -  Willingness and ability to comply with the study protocol for the duration of the&#xD;
             trial.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participation in any other investigational drug study (antimalarial or others) during&#xD;
             the previous 30 days&#xD;
&#xD;
          -  Known hypersensitivity to the study drugs&#xD;
&#xD;
          -  Severe malaria&#xD;
&#xD;
          -  Danger signs: not able to drink or breast-feed, vomiting (&gt; twice in 24hours), recent&#xD;
             history of convulsions (more than 1 in 24h), unconscious state, unable to sit or&#xD;
             stand;&#xD;
&#xD;
          -  Known intercurrent illness or any condition (cardiac, renal, hepatic diseases) which&#xD;
             would place the subject at undue risk or interfere with the results of the study.&#xD;
&#xD;
          -  Severe malnutrition (defined as weight for height less than 70% of the median NCHS/WHO&#xD;
             reference)&#xD;
&#xD;
          -  Known pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Months</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Halidou Tinto, PharmD, PhD</last_name>
    <role>Study Director</role>
    <affiliation>IRSS/Centre Muraz</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Clinical Reaserch Unit</name>
      <address>
        <city>Nanoro</city>
        <state>Boulkiemdé</state>
        <zip>218</zip>
        <country>Burkina Faso</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Burkina Faso</country>
  </location_countries>
  <verification_date>July 2015</verification_date>
  <study_first_submitted>September 29, 2012</study_first_submitted>
  <study_first_submitted_qc>October 1, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 2, 2012</study_first_posted>
  <last_update_submitted>July 29, 2015</last_update_submitted>
  <last_update_submitted_qc>July 29, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 31, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Centre Muraz</investigator_affiliation>
    <investigator_full_name>Tinto Halidou</investigator_full_name>
    <investigator_title>PharmD, PhD</investigator_title>
  </responsible_party>
  <keyword>Treatment, diagnosis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Malaria</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Artesunate</mesh_term>
    <mesh_term>Lumefantrine</mesh_term>
    <mesh_term>Artemether</mesh_term>
    <mesh_term>Artemether, Lumefantrine Drug Combination</mesh_term>
    <mesh_term>Amodiaquine</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/NCT01697787
org study id: CM/CRUN0012
nct id: NCT01697787
lead sponsor: 
collaborator: 
has dmc: No
This is a two-arm study aiming at recruiting 150 patients to assess the efficacy of
      Amodiaquine-Artesunate (ASAQ) and Artemether-Lumefantrine (AL) in patients with a microscopy
      positive diagnosis of malaria in Nanoro, Burkina Faso and assess the performance of the Rapid
      Diagnosis Tests (RDTs) compared to the microscopy.
Study background and purpose

        -  Resistance to usual drugs was widespread and has required a change of the malaria
           treatment by several countries

        -  Several countries have changed their first-line treatments to ACTs; mainly AL and ASAQ.
           & have adopted the use of RDTs prior to treatment

        -  Indeed, this contributes to decrease the number of unnecessary treatments and thus
           improve the management of malaria cases.

        -  In February 2005, Burkina Faso changed its national drug policy from Chloroquine to
           Amodiaquine-Artesunate (ASAQ) and Artemether-Lumefantrine (AL)

        -  the country has also implemented the strategy of using the Rapid Diagnosis Tests (RDTs)
           for the diagnosis of malaria prior to treatment

        -  Though endemic countries are being encouraged to implement RDTs, choosing a particular
           RDT is not easy as several brands are available on the market.

        -  In addition, little information on the performance of RDTs in Africa is available and
           recently quality problems have been reported with some RDTs.

        -  In this context, it is important to locally assess the performance of RDTs compared with
           the microscopy, which is the gold standard for the malaria diagnosis and to assess the
           efficacy of the new drugs used for malaria treatment

      This is a phase IV two-arm randomized open-label study aiming at recruiting 150 patients to
      assess the efficacy of ASAQ and AL in patients with a microscopy positive diagnosis of
      malaria in Nanoro, Burkina Faso and assess the performance of the RDT compared to the
      microscopy
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Rate of treatment failures
time frame: 28 days
description: The rate of the two ACTs treatment failures at day 28: all treatment failures, both parasitological and clinical (positive blood slide at day 28)
measure: RDT performance Vs microscopy
time frame: 28 days
description: The proportion of discrepancies between the RDT and the microscopy results
measure: Fever clearance time (FCT) Fever Clearance Time
time frame: 28 days
description: Fever clearance time will be defined as the time (in days) from the time of the drug administration to the first two consecutive measurements on 2 different days of axillary temperature below 37.5°C
measure: Gametocytes carriage
time frame: 28 days
description: Gametocytes carriage including the estimation of the prevalence and density
arm group label: Amodiaquine-Artesunate
arm group type: Other
description: ASAQ is produced by Sanofi-Aventis as CoarsucamTM and as artesunate-amodiaquine Winthrop®
arm group label: Artemether-Lumefantrine
arm group type: Other
description: AL (tablets containing 20 mg of artemether and 120 mg of lumefantrine) is produced by Novartis
intervention type: Drug
intervention name: Amodiaquine-Artesunate
description: If necessary, the study drug will be crushed, dissolved in water and squirted into the mouth using a spoonful. Administration of the treatments will be directly observed. After drug administration, patients will be kept for at least 30 minutes in the clinic. A dose will be repeated in full if vomiting occurs within 30 minutes of administration and halved if vomiting is between 30 minutes and 1 hour post dosing.
arm group label: Amodiaquine-Artesunate
other name: ASAQ Winthrop, Coarsucam
intervention type: Drug
intervention name: Artemether-lumefantrine
description: If necessary, the study drug will be crushed, dissolved in water and squirted into the mouth using a spoonful. Administration of the treatments will be directly observed. After drug administration, patients will be kept for at least 30 minutes in the clinic. A dose will be repeated in full if vomiting occurs within 30 minutes of administration and halved if vomiting is between 30 minutes and 1 hour post dosing.
arm group label: Artemether-Lumefantrine
other name: Coartem, Riamet
criteria: 
gender: All
minimum age: 6 Months
maximum age: 90 Years
healthy volunteers: No
last name: Halidou Tinto, PharmD, PhD
role: Study Director
affiliation: IRSS/Centre Muraz
facility: 
country: Burkina Faso
responsible party type: Principal Investigator
investigator affiliation: Centre Muraz
investigator full name: Tinto Halidou
investigator title: PharmD, PhD
mesh term: Malaria
mesh term: Artesunate
mesh term: Lumefantrine
mesh term: Artemether
mesh term: Artemether, Lumefantrine Drug Combination
mesh term: Amodiaquine