<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/NCT03241901</url>
  </required_header>
  <id_info>
    <org_study_id>No. 01.05.2017</org_study_id>
    <nct_id>NCT03241901</nct_id>
  </id_info>
  <brief_title>&quot;Prolonging the Therapeutic Life Span of Artemisinin-based Combination Therapies (ACT) in Bagamoyo District, Tanzania&quot;</brief_title>
  <acronym>ALU-PQ</acronym>
  <official_title>&quot;Aiming at Prolonging the Therapeutic Life Span of Artemisinin-based Combination Therapies (ACT) in an Era of Imminent Plasmodium Falciparum Resistance in Bagamoyo District, Tanzania - New Strategies With Old Tools&quot;</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Muhimbili University of Health and Allied Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Uppsala University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Karolinska Institutet</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The University of Western Australia</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Muhimbili University of Health and Allied Sciences</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This clinical trial evaluates the advantage of prolonging the therapeutic life span of&#xD;
      Artemether-lumefantrine from 3 days to 6 days, and addition of single low dose of Primaquine&#xD;
      0.25mg/kg. The study will have two arms, one that will receive standard treatment of&#xD;
      uncomplicated malaria with Artemether-lumefantrine, and the other arm will receive the&#xD;
      prolonged dose of 6 days together with single low dose primaquine. This approach is expected&#xD;
      to provide strategies for malaria control in an era of imminent Plasmodium falciparum&#xD;
      resistance.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Despite documented high cure rates of ACT in Tanzania, and Africa elsewhere, clinical trials&#xD;
      conducted in Tanzania with Swedish International Development cooperation Agency (SIDA) and&#xD;
      Swedish Research Council support, provide evidence for in vivo selection of lumefantrine&#xD;
      tolerant/resistant parasites among recurrent infections. Similarly, molecular epidemiology&#xD;
      studies from Bagamoyo District, Tanzania, have shown temporal selection of lumefantrine&#xD;
      associated genetic tolerance/resistance markers in the parasite population following wide&#xD;
      scale use of Artemether-lumefantrine, but without signs of compromised treatment efficacy.&#xD;
&#xD;
      During the last decade, and despite the documented rapid microscopy determined parasite&#xD;
      clearance of artemether-lumefantrine in Bagamoyo District, interest has developed in&#xD;
      understanding the observation of high residual polymerase chain reaction (PCR) determined&#xD;
      positivity rate on day 3 after supervised artemether-lumefantrine treatment in the magnitude&#xD;
      of almost 30% in previous assessments from 2015. Using deep sequencing approaches studies&#xD;
      have recently detected PCR determined delayed parasite clearance curves in P. falciparum&#xD;
      sub-populations in Bagamoyo District. The clearance times by PCR of these sub-populations&#xD;
      were similar to artemisinin resistant parasites in Myanmar as assessed by microscopy, but the&#xD;
      former did, importantly, not harbor any of the described mutations in Kelch13 propeller&#xD;
      associated with artemisinin resistance. However, these Tanzanian parasite sub-populations&#xD;
      need to be further studied and characterized since they may provide important clues to the&#xD;
      understanding of artemisinin survival strategies among the East African P. falciparum&#xD;
      parasite population.&#xD;
&#xD;
      Taken together, longitudinal clinical and molecular data described above from Tanzania, East&#xD;
      Africa, extending from pre-ACT implementation, (before 2006), to a decade of wide scale&#xD;
      artemether-lumefantrine use in Bagamoyo district, provide evidence for declining&#xD;
      susceptibility to ACT, both to artemether and lumefantrine, among the P. falciparum&#xD;
      population. These parasites (&quot;last man standing&quot;) that survived 10 years of ACT exposure have&#xD;
      indeed shown excellent survival instincts and may thus be particularly resistant prone.&#xD;
      However, if P. falciparum resistance to ACT develops in Africa, this will have devastating&#xD;
      effects on malaria morbidity and mortality and may swiftly ruin the improvements the global&#xD;
      malaria community achieved during the past decade with ACT as a key component for success.&#xD;
&#xD;
      Based on the above the investigators suggest prolonged treatment with ACT and addition of&#xD;
      transmission blocking treatment using a single low dose of primaquine administered on the&#xD;
      last day of ACT treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 27, 2017</start_date>
  <completion_date type="Actual">February 17, 2018</completion_date>
  <primary_completion_date type="Actual">December 28, 2017</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>Single (Participant)</masking>
    <masking_description>Due to the objectives of the study, the identity of test and control treatments will be known only to investigators, research staff, but NOT patients. The following study procedures will be in place to ensure single-blind administration of study treatments.&#xD;
Access to the randomization code will be strictly controlled.&#xD;
A taste-matching agent for the placebo.&#xD;
Packaging and labeling of test and control treatments will be identical to maintain the blind.&#xD;
During the study, the blind may be broken only in emergencies when knowledge of the patient's treatment group is necessary for further patient management. When possible, the Investigator should discuss the emergency with the Medical Monitor prior to un-blinding</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Parasite Clearance Times</measure>
    <time_frame>5 Days</time_frame>
    <description>Proportion of PCR detectable parasitemia on Day 5</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Parasite Clearance Times</measure>
    <time_frame>7 Days</time_frame>
    <description>Proportion of PCR detectable parasitemia on Day 7</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Gametocyte Clearance</measure>
    <time_frame>42 Days</time_frame>
    <description>PCR determined gametocyte carriage/clearance times</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cure Rate</measure>
    <time_frame>28 Days</time_frame>
    <description>Crude and PCR corrected cure rates by day 28</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Genetic Markers of Drug Resistance</measure>
    <time_frame>6 Days</time_frame>
    <description>Selection of genetic drug resistance markers during the early treatment phase</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics</measure>
    <time_frame>7 Days</time_frame>
    <description>Area under the plasma concentration versus time curve (AUC) of Artemether-lumefantrine</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Peak Plasma Concentration (Cmax)</measure>
    <time_frame>At hours, -1, 0 ,2 ,4 ,12, 24, 36, 40, 48, 52, 60, 72, 84, 88, 96, 100, 108,120, 132, 134, 136 ,144, 168, 192, 240, 336, 504 and 672</time_frame>
    <description>Peak Plasma Concentration (Cmax) of Lumefantrine measured for 28 days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Day 7 plasma lumefantrine</measure>
    <time_frame>7 Days</time_frame>
    <description>Day 7 plasma lumefantrine concentrations in the respective arms</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Fever Clearance Time</measure>
    <time_frame>7 Days</time_frame>
    <description>This will assess the rate of clearance of fever after initiation of treatment</description>
  </other_outcome>
  <other_outcome>
    <measure>Incidence of Treatment-Emergent Adverse Events (Safety and tolerability)</measure>
    <time_frame>Baseline and day 7</time_frame>
    <description>Incidence of prolonged Corrected QT interval in ECG measures at day 7</description>
  </other_outcome>
  <other_outcome>
    <measure>Incidence of Severe anemia</measure>
    <time_frame>baseline to day 7, 14, 28, 42</time_frame>
    <description>Proportion of Severe anemia as measured by hemoglobin baseline to day 7, 14, 28, 42</description>
  </other_outcome>
  <other_outcome>
    <measure>Incidence of Biochemistry parameters derangements</measure>
    <time_frame>Baseline and day 7</time_frame>
    <description>Proportions of biochemistry parameters (ALAT, ASAT, Bilirubin and Creatinine) outside the normal range .</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">280</enrollment>
  <condition>Malaria,Falciparum</condition>
  <arm_group>
    <arm_group_label>3 Days Artemether-Lumefantrine + Placebo</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Oral tablets of artemether-lumefantrine (20-120mg):&#xD;
tablet for 5-14kg;&#xD;
tablets for 15-24 kg;&#xD;
tables for 25 - 34kg and&#xD;
tablets for above 35 Kg. The full course of treatment is 6-doses for 3 days given twice daily, at 0, 8, 24, 36, 48, 60 with the dose being given as directly observed therapy.&#xD;
Oral placebo after completion of the standard 3 days-six dose regimen. A fatty snack (biscuits) will be administered together with all artemether-lumefantrine doses to optimize absorption.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>6Days Artemether/Lumefantrine+Primaquine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Artemether-lumefantrine (20-120mg) twice daily for 6 days according to body weight as in the active comparator arm.&#xD;
And in addition to that, , a single 0.25 mg/kg primaquine dose (Primaquine phosphate) will be administered concomitantly with the last (i.e. twelfth) artemether-lumefantrine dose. Primaquine will be prepared and administered in an aqueous solution.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Artemether-Lumefantrine Tab 20-120mg</intervention_name>
    <description>Artemether-Lumefantrine Tablet 20-120mg</description>
    <arm_group_label>3 Days Artemether-Lumefantrine + Placebo</arm_group_label>
    <arm_group_label>6Days Artemether/Lumefantrine+Primaquine</arm_group_label>
    <other_name>ALU</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Primaquine Phosphate 0.25 mg/kg</intervention_name>
    <description>Primaquine Phosphate 0.25 mg/kg</description>
    <arm_group_label>6Days Artemether/Lumefantrine+Primaquine</arm_group_label>
    <other_name>PQ</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Aqueous solution prepared to mimic the taste of the intervention drug.</description>
    <arm_group_label>3 Days Artemether-Lumefantrine + Placebo</arm_group_label>
    <other_name>Placebo for Artemether Lumefantrine + Primaquine Phosphate</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age more than 1 year and less than 65 years.&#xD;
&#xD;
          2. Weight 10 kg and above;&#xD;
&#xD;
          3. Body temperature ≥37.5°C or history of fever in the last 24 hours;&#xD;
&#xD;
          4. Microscopy determined asexual P. falciparum mono-infection regardless of parasitemia&#xD;
&#xD;
          5. Normal - corrected QT Interval in Baseline ECG of less than 440ms in male and 460ms in&#xD;
             females&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Symptoms/signs of severe malaria or danger signs;&#xD;
&#xD;
          2. Pregnancy, Breastfeeding or unwilling to practice birth control during participation&#xD;
             in the study.&#xD;
&#xD;
          3. Known allergy to study medications;&#xD;
&#xD;
          4. Hb &lt;8 g/dl;&#xD;
&#xD;
          5. Reported antimalarial intake within last 2 weeks;&#xD;
&#xD;
          6. On regular medication, which may interfere with antimalarial pharmacokinetics and&#xD;
&#xD;
          7. Blood transfusion within last 90 days.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Year</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lwidiko E Mhamilawa, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Muhimbili University of Health and Allied Sciences</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Andreas Martensson, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Uppsala University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Fukayosi Dispensary</name>
      <address>
        <city>Bagamoyo</city>
        <state>Pwani</state>
        <zip>+255</zip>
        <country>Tanzania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yombo Dispensary</name>
      <address>
        <city>Bagamoyo</city>
        <state>Yombo</state>
        <zip>+255</zip>
        <country>Tanzania</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Tanzania</country>
  </location_countries>
  <link>
    <url>http://apps.who.int/iris/bitstream/10665/200018/1/9789241565158_eng.pdf</url>
    <description>&quot;WHO World Malaria Report 2015,&quot; Geneva, Switzerland, 2015</description>
  </link>
  <link>
    <url>http://apps.who.int/iris/bitstream/10665/162441/1/9789241549127_eng.pdf</url>
    <description>WHO guidelines for the treatment of malaria 2015, 3rd Edition. Geneva, Switzerland, 2015</description>
  </link>
  <link>
    <url>http://www.uio.no/studier/emner/matnat/ifi/INF5761/v16/timeplan/example-bagamoyo-district-profile-tanzania.pdf</url>
    <description>BAGAMOYO DISTRICT HEALTH PROFILE</description>
  </link>
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  <verification_date>March 2018</verification_date>
  <study_first_submitted>July 5, 2017</study_first_submitted>
  <study_first_submitted_qc>August 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 8, 2017</study_first_posted>
  <last_update_submitted>March 24, 2018</last_update_submitted>
  <last_update_submitted_qc>March 24, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">March 27, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Muhimbili University of Health and Allied Sciences</investigator_affiliation>
    <investigator_full_name>Dr. Lwidiko Edward</investigator_full_name>
    <investigator_title>Medical Doctor</investigator_title>
  </responsible_party>
  <keyword>Artemether-Lumefantrine, Primaquine</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Malaria, Falciparum</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lumefantrine</mesh_term>
    <mesh_term>Artemether</mesh_term>
    <mesh_term>Primaquine</mesh_term>
    <mesh_term>Artemether, Lumefantrine Drug Combination</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol, Statistical Analysis Plan, and Informed Consent Form</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>July 4, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/01/NCT03241901/Prot_SAP_ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03241901
org study id: No. 01.05.2017
nct id: NCT03241901
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This clinical trial evaluates the advantage of prolonging the therapeutic life span of
      Artemether-lumefantrine from 3 days to 6 days, and addition of single low dose of Primaquine
      0.25mg/kg. The study will have two arms, one that will receive standard treatment of
      uncomplicated malaria with Artemether-lumefantrine, and the other arm will receive the
      prolonged dose of 6 days together with single low dose primaquine. This approach is expected
      to provide strategies for malaria control in an era of imminent Plasmodium falciparum
      resistance.
Despite documented high cure rates of ACT in Tanzania, and Africa elsewhere, clinical trials
      conducted in Tanzania with Swedish International Development cooperation Agency (SIDA) and
      Swedish Research Council support, provide evidence for in vivo selection of lumefantrine
      tolerant/resistant parasites among recurrent infections. Similarly, molecular epidemiology
      studies from Bagamoyo District, Tanzania, have shown temporal selection of lumefantrine
      associated genetic tolerance/resistance markers in the parasite population following wide
      scale use of Artemether-lumefantrine, but without signs of compromised treatment efficacy.

      During the last decade, and despite the documented rapid microscopy determined parasite
      clearance of artemether-lumefantrine in Bagamoyo District, interest has developed in
      understanding the observation of high residual polymerase chain reaction (PCR) determined
      positivity rate on day 3 after supervised artemether-lumefantrine treatment in the magnitude
      of almost 30% in previous assessments from 2015. Using deep sequencing approaches studies
      have recently detected PCR determined delayed parasite clearance curves in P. falciparum
      sub-populations in Bagamoyo District. The clearance times by PCR of these sub-populations
      were similar to artemisinin resistant parasites in Myanmar as assessed by microscopy, but the
      former did, importantly, not harbor any of the described mutations in Kelch13 propeller
      associated with artemisinin resistance. However, these Tanzanian parasite sub-populations
      need to be further studied and characterized since they may provide important clues to the
      understanding of artemisinin survival strategies among the East African P. falciparum
      parasite population.

      Taken together, longitudinal clinical and molecular data described above from Tanzania, East
      Africa, extending from pre-ACT implementation, (before 2006), to a decade of wide scale
      artemether-lumefantrine use in Bagamoyo district, provide evidence for declining
      susceptibility to ACT, both to artemether and lumefantrine, among the P. falciparum
      population. These parasites ("last man standing") that survived 10 years of ACT exposure have
      indeed shown excellent survival instincts and may thus be particularly resistant prone.
      However, if P. falciparum resistance to ACT develops in Africa, this will have devastating
      effects on malaria morbidity and mortality and may swiftly ruin the improvements the global
      malaria community achieved during the past decade with ACT as a key component for success.

      Based on the above the investigators suggest prolonged treatment with ACT and addition of
      transmission blocking treatment using a single low dose of primaquine administered on the
      last day of ACT treatment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
masking description: Due to the objectives of the study, the identity of test and control treatments will be known only to investigators, research staff, but NOT patients. The following study procedures will be in place to ensure single-blind administration of study treatments.
Access to the randomization code will be strictly controlled.
A taste-matching agent for the placebo.
Packaging and labeling of test and control treatments will be identical to maintain the blind.
During the study, the blind may be broken only in emergencies when knowledge of the patient's treatment group is necessary for further patient management. When possible, the Investigator should discuss the emergency with the Medical Monitor prior to un-blinding
measure: Parasite Clearance Times
time frame: 5 Days
description: Proportion of PCR detectable parasitemia on Day 5
measure: Parasite Clearance Times
time frame: 7 Days
description: Proportion of PCR detectable parasitemia on Day 7
measure: Gametocyte Clearance
time frame: 42 Days
description: PCR determined gametocyte carriage/clearance times
measure: Cure Rate
time frame: 28 Days
description: Crude and PCR corrected cure rates by day 28
measure: Genetic Markers of Drug Resistance
time frame: 6 Days
description: Selection of genetic drug resistance markers during the early treatment phase
measure: Pharmacokinetics
time frame: 7 Days
description: Area under the plasma concentration versus time curve (AUC) of Artemether-lumefantrine
measure: Peak Plasma Concentration (Cmax)
time frame: At hours, -1, 0 ,2 ,4 ,12, 24, 36, 40, 48, 52, 60, 72, 84, 88, 96, 100, 108,120, 132, 134, 136 ,144, 168, 192, 240, 336, 504 and 672
description: Peak Plasma Concentration (Cmax) of Lumefantrine measured for 28 days
measure: Day 7 plasma lumefantrine
time frame: 7 Days
description: Day 7 plasma lumefantrine concentrations in the respective arms
measure: Fever Clearance Time
time frame: 7 Days
description: This will assess the rate of clearance of fever after initiation of treatment
measure: Incidence of Treatment-Emergent Adverse Events (Safety and tolerability)
time frame: Baseline and day 7
description: Incidence of prolonged Corrected QT interval in ECG measures at day 7
measure: Incidence of Severe anemia
time frame: baseline to day 7, 14, 28, 42
description: Proportion of Severe anemia as measured by hemoglobin baseline to day 7, 14, 28, 42
measure: Incidence of Biochemistry parameters derangements
time frame: Baseline and day 7
description: Proportions of biochemistry parameters (ALAT, ASAT, Bilirubin and Creatinine) outside the normal range .
arm group label: 3 Days Artemether-Lumefantrine + Placebo
arm group type: Active Comparator
description: Oral tablets of artemether-lumefantrine (20-120mg):
tablet for 5-14kg;
tablets for 15-24 kg;
tables for 25 - 34kg and
tablets for above 35 Kg. The full course of treatment is 6-doses for 3 days given twice daily, at 0, 8, 24, 36, 48, 60 with the dose being given as directly observed therapy.
Oral placebo after completion of the standard 3 days-six dose regimen. A fatty snack (biscuits) will be administered together with all artemether-lumefantrine doses to optimize absorption.
arm group label: 6Days Artemether/Lumefantrine+Primaquine
arm group type: Experimental
description: Artemether-lumefantrine (20-120mg) twice daily for 6 days according to body weight as in the active comparator arm.
And in addition to that, , a single 0.25 mg/kg primaquine dose (Primaquine phosphate) will be administered concomitantly with the last (i.e. twelfth) artemether-lumefantrine dose. Primaquine will be prepared and administered in an aqueous solution.
intervention type: Drug
intervention name: Artemether-Lumefantrine Tab 20-120mg
description: Artemether-Lumefantrine Tablet 20-120mg
arm group label: 3 Days Artemether-Lumefantrine + Placebo
arm group label: 6Days Artemether/Lumefantrine+Primaquine
other name: ALU
intervention type: Drug
intervention name: Primaquine Phosphate 0.25 mg/kg
description: Primaquine Phosphate 0.25 mg/kg
arm group label: 6Days Artemether/Lumefantrine+Primaquine
other name: PQ
intervention type: Other
intervention name: Placebo
description: Aqueous solution prepared to mimic the taste of the intervention drug.
arm group label: 3 Days Artemether-Lumefantrine + Placebo
other name: Placebo for Artemether Lumefantrine + Primaquine Phosphate
criteria: 
gender: All
minimum age: 1 Year
maximum age: 65 Years
healthy volunteers: No
last name: Lwidiko E Mhamilawa, MD
role: Principal Investigator
affiliation: Muhimbili University of Health and Allied Sciences
last name: Andreas Martensson, PhD
role: Study Chair
affiliation: Uppsala University
facility: 
facility: 
country: Tanzania
url: http://apps.who.int/iris/bitstream/10665/200018/1/9789241565158_eng.pdf
description: "WHO World Malaria Report 2015," Geneva, Switzerland, 2015
url: http://apps.who.int/iris/bitstream/10665/162441/1/9789241549127_eng.pdf
description: WHO guidelines for the treatment of malaria 2015, 3rd Edition. Geneva, Switzerland, 2015
url: http://www.uio.no/studier/emner/matnat/ifi/INF5761/v16/timeplan/example-bagamoyo-district-profile-tanzania.pdf
description: BAGAMOYO DISTRICT HEALTH PROFILE
citation: Sisowath C, Stromberg J, Martensson A, Msellem M, Obondo C, Bjorkman A, Gil JP. In vivo selection of Plasmodium falciparum pfmdr1 86N coding alleles by artemether-lumefantrine (Coartem). J Infect Dis. 2005 Mar 15;191(6):1014-7. doi: 10.1086/427997. Epub 2005 Feb 8.
PMID: 15717281
citation: Martensson A, Stromberg J, Sisowath C, Msellem MI, Gil JP, Montgomery SM, Olliaro P, Ali AS, Bjorkman A. Efficacy of artesunate plus amodiaquine versus that of artemether-lumefantrine for the treatment of uncomplicated childhood Plasmodium falciparum malaria in Zanzibar, Tanzania. Clin Infect Dis. 2005 Oct 15;41(8):1079-86. doi: 10.1086/444460. Epub 2005 Sep 13.
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citation: Malmberg M, Ngasala B, Ferreira PE, Larsson E, Jovel I, Hjalmarsson A, Petzold M, Premji Z, Gil JP, Bjorkman A, Martensson A. Temporal trends of molecular markers associated with artemether-lumefantrine tolerance/resistance in Bagamoyo district, Tanzania. Malar J. 2013 Mar 18;12:103. doi: 10.1186/1475-2875-12-103.
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citation: Mideo N, Bailey JA, Hathaway NJ, Ngasala B, Saunders DL, Lon C, Kharabora O, Jamnik A, Balasubramanian S, Bjorkman A, Martensson A, Meshnick SR, Read AF, Juliano JJ. A deep sequencing tool for partitioning clearance rates following antimalarial treatment in polyclonal infections. Evol Med Public Health. 2016 Jan 27;2016(1):21-36. doi: 10.1093/emph/eov036.
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citation: Mwaiswelo R, Ngasala BE, Jovel I, Gosling R, Premji Z, Poirot E, Mmbando BP, Bjorkman A, Martensson A. Safety of a single low-dose of primaquine in addition to standard artemether-lumefantrine regimen for treatment of acute uncomplicated Plasmodium falciparum malaria in Tanzania. Malar J. 2016 Jun 10;15:316. doi: 10.1186/s12936-016-1341-3.
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responsible party type: Principal Investigator
investigator affiliation: Muhimbili University of Health and Allied Sciences
investigator full name: Dr. Lwidiko Edward
investigator title: Medical Doctor
mesh term: Malaria, Falciparum
mesh term: Lumefantrine
mesh term: Artemether
mesh term: Primaquine
mesh term: Artemether, Lumefantrine Drug Combination
sharing ipd: No
provided document: 