<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/NCT01669941</url>
  </required_header>
  <id_info>
    <org_study_id>STOPMiP-KENYA</org_study_id>
    <nct_id>NCT01669941</nct_id>
  </id_info>
  <brief_title>Efficacy of Intermittent Screening and Treatment or Intermittent Preventive Treatment (IPT) With Dihydroartemisinin-Piperaquine, Versus IPT With Sulfadoxine-Pyrimethamine for the Control of Malaria in Pregnancy in Kenya</brief_title>
  <acronym>STOP MiP KENYA</acronym>
  <official_title>Intermittent Screening and Treatment (IST) or Intermittent Preventive Treatment (IPT) With Dihydroartemisinin-Piperaquine, Versus IPT With Sulfadoxine-Pyrimethamine for the Control of Malaria in Pregnancy in Kenya: a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kenya Medical Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Centers for Disease Control and Prevention</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
    <collaborator>
      <agency>Liverpool School of Tropical Medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>London School of Hygiene and Tropical Medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Kenya Medical Research Institute</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Malaria in pregnancy (MiP) due to Plasmodium falciparum infection is a major cause of&#xD;
      maternal morbidity and poor birth outcomes. Intermittent preventive treatment in pregnancy&#xD;
      (IPTp) with Sulfadoxine pyrimethamine (SP), the administration of SP at predefined intervals&#xD;
      in the second and third trimesters of pregnancy irrespective of the presence of malaria&#xD;
      parasitemia, is currently recommended for HIV-negative women in all areas with stable&#xD;
      moderate to high transmission of malaria. Due to increasing resistance to SP, it is no longer&#xD;
      used as a treatment for symptomatic malaria, and the efficacy of IPTp-SP seems to be&#xD;
      decreased. This study aims to look at a new drug, Dihydroartemisinin-Piperaquine (DP) for&#xD;
      IPTp, as well as to explore the strategy of intermittent screening and treatment in pregnancy&#xD;
      (ISTp) with DP. This strategy uses increased screening at time of focused antenatal care&#xD;
      (FANC) with treatment of women who screen positive.&#xD;
&#xD;
      The hypothesis is that the efficacy of both IPTp-DP and ISTp-DP will be associated with a&#xD;
      reduction in malaria infection at delivery among HIV(-) women when compared to IPTp-SP, in an&#xD;
      area with decreasing malaria transmission and high levels of SP resistance in Kenya.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Malaria in pregnancy (MiP) due to Plasmodium falciparum infection is a major cause of&#xD;
      maternal morbidity and poor birth outcomes. Pregnant women are at increased risk of more&#xD;
      frequent and severe malaria infections than are non-pregnant women. Intermittent preventive&#xD;
      treatment in pregnancy (IPTp), the administration of treatment doses of an antimalarial at&#xD;
      predefined intervals in the second and third trimesters of pregnancy irrespective of the&#xD;
      presence of malaria parasitemia, is currently recommended for HIV-negative women in all areas&#xD;
      with stable moderate to high transmission of malaria. The strategy is thought to work by&#xD;
      providing intermittent clearance or suppression of parasites in the placenta, and preventing&#xD;
      new infections from occurring through the prophylactic effect of the recommended drug for&#xD;
      IPTp, sulfadoxine-pyrimethamine (SP).&#xD;
&#xD;
      SP is the only drug currently used for IPTp. Due to increasing resistance to SP, it is no&#xD;
      longer used as a treatment for symptomatic malaria, however, IPTp with SP remains effective&#xD;
      even in areas where SP resistance in children under five (determined by in vivo efficacy&#xD;
      studies) is up to 26%. SP therefore continues to be used for IPTp in many countries where it&#xD;
      is no longer used for treatment of symptomatic malaria. However, more recent data from&#xD;
      northern Tanzania and Malawi indicate that at higher rates of resistance, IPTp-SP may no&#xD;
      longer be effective, and could potentially be harmful.&#xD;
&#xD;
      In view of this data, a search for alternatives to IPTp-SP is warranted. One strategy would&#xD;
      be to choose a different drug for IPTp. Of the available combinations,&#xD;
      Dihydroartemisinin-Piperaquine (DP) remains one of the most attractive options because of the&#xD;
      long half-life of piperaquine (PQ) and the demonstrated efficacy and safety in pregnancy.&#xD;
      Another strategy to consider is intermittent screening and treatment in pregnancy (ISTp),&#xD;
      whereby there is increased screening at time of focused antenatal care (FANC) with treatment&#xD;
      of women who screen positive. The same properties (long half-life, tolerability, safety, once&#xD;
      daily dosing) which make DP a good choice for IPTp also make it one of the best available&#xD;
      options for ISTp.&#xD;
&#xD;
      This study aims to compare the efficacy of IPTp-SP against that of IPTp-DP and ISTp-DP to&#xD;
      determine if these alternate strategies are associated with a reduction in malaria infection&#xD;
      at delivery among HIV(-) women in an area with decreasing malaria transmission and high&#xD;
      levels of SP resistance in Kenya.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">December 2015</completion_date>
  <primary_completion_date type="Actual">October 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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Maternal malaria at delivery</measure>
    <time_frame>Delivery</time_frame>
    <description>Active or recent infection at delivery measured as the composite of peripheral and placental malaria, detected by: positive peripheral blood smear or RDT or positive placental smear, RDT, or histopathology</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Decreased fetal morbidity</measure>
    <time_frame>Delivery</time_frame>
    <description>Decreased fetal morbidity, defined as the composite of any of the following:&#xD;
Preterm birth (birth before 37 weeks gestation)&#xD;
Low-birth-weight (birth weight under 2,500 grams)&#xD;
Small for gestational age (SGA) defined as a binary outcome of &lt;10th percentile of fetal weight for attained gestational age using the Landis fetal weight nomogram from the Democratic Republic of Congo</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of fetal congenital malformations</measure>
    <time_frame>At delivery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics- piperaquine level</measure>
    <time_frame>At baseline, and day 2 and day 7 following dosing.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>level of antibodies to variant surface antigens (VSAs)</measure>
    <time_frame>At delivery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of maternal adverse events</measure>
    <time_frame>At each ANC visit and at delivery</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">1546</enrollment>
  <condition>Pregnancy</condition>
  <condition>Malaria</condition>
  <arm_group>
    <arm_group_label>IPTp-DP</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>At each ANC visit, women will be given treatment with Dihydroartemisinin-piperaquine for three days, with the daily number of tablets depending on the weight of the woman; two tablets for women weighing 24- 35.9kg, three tablets for women weighing 36 to 74.9 kg, and four tablets for women weighing 75kg or more. The first dose will be observed; the woman will be given the additional 2 doses to take at home and there may be a home visit to confirm that the tablets were taken.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ISTp-DP</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>At each ANC visit, women will be screened for malaria using a combined HRP-2/ pLDH (P. falciparum/ pan-malaria) rapid diagnostic test, and if they test positive, will be treated with dihydroartemisinin-piperaquine (DP). Each tablet will contain 40 mg dihydroartemisinin and 320 mg piperaquine. Treatment will be given for three days, with the daily number of tablets depending on the weight of the woman; two tablets for women weighing 24- 35.9kg, three tablets for women weighing 36 to 74.9 kg, and four tablets for women weighing 75kg or more. The first dose will be observed; the woman will be given the additional 2 doses to take at home</description>
  </arm_group>
  <arm_group>
    <arm_group_label>IPTp-SP</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Treatment with a single dose of three tablets of sulfadoxine-pyrimethamine, each containing sulfadoxine (500 mg) and pyrimethamine (25 mg) at each FANC visit. This is the standard regimen.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>IPTp-SP</intervention_name>
    <description>3 tablets of sulfadoxine (500 mg) and pyrimethamine (25 mg) given at each ANC visit</description>
    <arm_group_label>IPTp-SP</arm_group_label>
    <other_name>Fansidar</other_name>
    <other_name>SP</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>IPTp-DP</intervention_name>
    <description>At each ANC visit: treatment with Dihydroartemisinin-piperaquine for three days, with the daily number of tablets depending on the weight of the woman; two tablets for women weighing 24- 35.9kg, three tablets for women weighing 36 to 74.9 kg, and four tablets for women weighing 75kg or more. The first dose will be observed; the woman will be given the additional 2 doses to take at home and there may be a home visit to confirm that the tablets were taken.</description>
    <arm_group_label>IPTp-DP</arm_group_label>
    <other_name>Eurartesim</other_name>
    <other_name>Duocotexin</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ISTp-DP</intervention_name>
    <description>At each ANC visit, women will be screened for malaria using a combined HRP-2/ pLDH (P. falciparum/ pan-malaria) rapid diagnostic test, and if positive, treated with dihydroartemisinin-piperaquine. Each tablet will contain 40 mg dihydroartemisinin and 320 mg piperaquine. Treatment will be given for three days, with the daily number of tablets depending on the weight of the woman; two tablets for women weighing 24- 35.9kg, three tablets for women weighing 36 to 74.9 kg, and four tablets for women weighing 75kg or more. The first dose will be observed; the woman will be given the additional 2 doses to take at home</description>
    <arm_group_label>ISTp-DP</arm_group_label>
    <other_name>Eurartesim</other_name>
    <other_name>Duocotexin</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Viable pregnancy assessed by Doppler&#xD;
&#xD;
          2. Gestational age 16 to 32 weeks (inclusive) by fundal height&#xD;
&#xD;
          3. No history of IPTp use during this pregnancy&#xD;
&#xD;
          4. Willing to participate and complete the study schedule&#xD;
&#xD;
          5. Willing to sign or thumb print informed consent&#xD;
&#xD;
          6. Resident of study area and intending to stay in the area for the duration of the&#xD;
             follow-up&#xD;
&#xD;
          7. Willing to deliver in the labor ward of the study clinic or hospital&#xD;
&#xD;
          8. HIV negative at enrolment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. HIV positive or unknown&#xD;
&#xD;
          2. Residence outside study area or planning to move out in the 12 months following&#xD;
             enrolment&#xD;
&#xD;
          3. High risk pregnancy, including any pre-existing illness likely to cause complication&#xD;
             of pregnancy (hypertension, diabetes, asthma, epilepsy, renal disease, liver disease,&#xD;
             fistula repair, leg or spine deformity)&#xD;
&#xD;
          4. Severe anemia requiring blood transfusion (Hb ≤ 7.0 g/dL) at enrolment&#xD;
&#xD;
          5. Known allergy or previous adverse reaction to any of the study drugs&#xD;
&#xD;
          6. Unable to give informed consent (for example due to mental disability)&#xD;
&#xD;
          7. Previous inclusion in the same study&#xD;
&#xD;
          8. Gestational age &gt;32 weeks&#xD;
&#xD;
          9. Previous IPTp during the current pregnancy&#xD;
&#xD;
         10. Participating in other malaria intervention studies&#xD;
&#xD;
         11. Known or suspected cardiac disease&#xD;
&#xD;
         12. Patients taking drugs in any of the following classes: antiarrhythmic agents,&#xD;
             neuroleptics, macrolides, and certain antimalarial drugs such as mefloquine,&#xD;
             chloroquine, halofantrine and lumefantrine.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Meghna Desai, PhD MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Centers for Disease Control and Prevention</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Abraham Katana, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Kenya Medical Research Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Lwak Mission Hospital</name>
      <address>
        <city>Rarieda</city>
        <state>Nyanza</state>
        <country>Kenya</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Siaya District Hospital</name>
      <address>
        <city>Siaya</city>
        <state>Nyanza</state>
        <zip>40600</zip>
        <country>Kenya</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bondo District Hospital</name>
      <address>
        <city>Bondo</city>
        <zip>40601</zip>
        <country>Kenya</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Madiany sub-District Hospital</name>
      <address>
        <city>Madiany</city>
        <country>Kenya</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Kenya</country>
  </location_countries>
  <link>
    <url>https://www.ncbi.nlm.nih.gov/pubmed/26429700</url>
    <description>Publication</description>
  </link>
  <verification_date>March 2017</verification_date>
  <study_first_submitted>August 15, 2012</study_first_submitted>
  <study_first_submitted_qc>August 17, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 21, 2012</study_first_posted>
  <last_update_submitted>March 3, 2017</last_update_submitted>
  <last_update_submitted_qc>March 3, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">March 6, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Kenya Medical Research Institute</investigator_affiliation>
    <investigator_full_name>Abraham Katana, MD</investigator_full_name>
    <investigator_title>Medical Officer</investigator_title>
  </responsible_party>
  <keyword>Pregnancy</keyword>
  <keyword>Plasmodium</keyword>
  <keyword>Malaria</keyword>
  <keyword>Prevention</keyword>
  <keyword>Kenya</keyword>
  <keyword>Piperaquine</keyword>
  <keyword>Dihydroartemisinin-Piperaquine</keyword>
  <keyword>Sulfadoxine Pyrimethamine</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>Fanasil, pyrimethamine drug combination</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/NCT01669941
org study id: STOPMiP-KENYA
nct id: NCT01669941
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
Malaria in pregnancy (MiP) due to Plasmodium falciparum infection is a major cause of
      maternal morbidity and poor birth outcomes. Intermittent preventive treatment in pregnancy
      (IPTp) with Sulfadoxine pyrimethamine (SP), the administration of SP at predefined intervals
      in the second and third trimesters of pregnancy irrespective of the presence of malaria
      parasitemia, is currently recommended for HIV-negative women in all areas with stable
      moderate to high transmission of malaria. Due to increasing resistance to SP, it is no longer
      used as a treatment for symptomatic malaria, and the efficacy of IPTp-SP seems to be
      decreased. This study aims to look at a new drug, Dihydroartemisinin-Piperaquine (DP) for
      IPTp, as well as to explore the strategy of intermittent screening and treatment in pregnancy
      (ISTp) with DP. This strategy uses increased screening at time of focused antenatal care
      (FANC) with treatment of women who screen positive.

      The hypothesis is that the efficacy of both IPTp-DP and ISTp-DP will be associated with a
      reduction in malaria infection at delivery among HIV(-) women when compared to IPTp-SP, in an
      area with decreasing malaria transmission and high levels of SP resistance in Kenya.
Malaria in pregnancy (MiP) due to Plasmodium falciparum infection is a major cause of
      maternal morbidity and poor birth outcomes. Pregnant women are at increased risk of more
      frequent and severe malaria infections than are non-pregnant women. Intermittent preventive
      treatment in pregnancy (IPTp), the administration of treatment doses of an antimalarial at
      predefined intervals in the second and third trimesters of pregnancy irrespective of the
      presence of malaria parasitemia, is currently recommended for HIV-negative women in all areas
      with stable moderate to high transmission of malaria. The strategy is thought to work by
      providing intermittent clearance or suppression of parasites in the placenta, and preventing
      new infections from occurring through the prophylactic effect of the recommended drug for
      IPTp, sulfadoxine-pyrimethamine (SP).

      SP is the only drug currently used for IPTp. Due to increasing resistance to SP, it is no
      longer used as a treatment for symptomatic malaria, however, IPTp with SP remains effective
      even in areas where SP resistance in children under five (determined by in vivo efficacy
      studies) is up to 26%. SP therefore continues to be used for IPTp in many countries where it
      is no longer used for treatment of symptomatic malaria. However, more recent data from
      northern Tanzania and Malawi indicate that at higher rates of resistance, IPTp-SP may no
      longer be effective, and could potentially be harmful.

      In view of this data, a search for alternatives to IPTp-SP is warranted. One strategy would
      be to choose a different drug for IPTp. Of the available combinations,
      Dihydroartemisinin-Piperaquine (DP) remains one of the most attractive options because of the
      long half-life of piperaquine (PQ) and the demonstrated efficacy and safety in pregnancy.
      Another strategy to consider is intermittent screening and treatment in pregnancy (ISTp),
      whereby there is increased screening at time of focused antenatal care (FANC) with treatment
      of women who screen positive. The same properties (long half-life, tolerability, safety, once
      daily dosing) which make DP a good choice for IPTp also make it one of the best available
      options for ISTp.

      This study aims to compare the efficacy of IPTp-SP against that of IPTp-DP and ISTp-DP to
      determine if these alternate strategies are associated with a reduction in malaria infection
      at delivery among HIV(-) women in an area with decreasing malaria transmission and high
      levels of SP resistance in Kenya.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Maternal malaria at delivery
time frame: Delivery
description: Active or recent infection at delivery measured as the composite of peripheral and placental malaria, detected by: positive peripheral blood smear or RDT or positive placental smear, RDT, or histopathology
measure: Decreased fetal morbidity
time frame: Delivery
description: Decreased fetal morbidity, defined as the composite of any of the following:
Preterm birth (birth before 37 weeks gestation)
Low-birth-weight (birth weight under 2,500 grams)
Small for gestational age (SGA) defined as a binary outcome of <10th percentile of fetal weight for attained gestational age using the Landis fetal weight nomogram from the Democratic Republic of Congo
measure: Frequency of fetal congenital malformations
time frame: At delivery
measure: Pharmacokinetics- piperaquine level
time frame: At baseline, and day 2 and day 7 following dosing.
measure: level of antibodies to variant surface antigens (VSAs)
time frame: At delivery
measure: Frequency of maternal adverse events
time frame: At each ANC visit and at delivery
arm group label: IPTp-DP
arm group type: Experimental
description: At each ANC visit, women will be given treatment with Dihydroartemisinin-piperaquine for three days, with the daily number of tablets depending on the weight of the woman; two tablets for women weighing 24- 35.9kg, three tablets for women weighing 36 to 74.9 kg, and four tablets for women weighing 75kg or more. The first dose will be observed; the woman will be given the additional 2 doses to take at home and there may be a home visit to confirm that the tablets were taken.
arm group label: ISTp-DP
arm group type: Experimental
description: At each ANC visit, women will be screened for malaria using a combined HRP-2/ pLDH (P. falciparum/ pan-malaria) rapid diagnostic test, and if they test positive, will be treated with dihydroartemisinin-piperaquine (DP). Each tablet will contain 40 mg dihydroartemisinin and 320 mg piperaquine. Treatment will be given for three days, with the daily number of tablets depending on the weight of the woman; two tablets for women weighing 24- 35.9kg, three tablets for women weighing 36 to 74.9 kg, and four tablets for women weighing 75kg or more. The first dose will be observed; the woman will be given the additional 2 doses to take at home
arm group label: IPTp-SP
arm group type: Active Comparator
description: Treatment with a single dose of three tablets of sulfadoxine-pyrimethamine, each containing sulfadoxine (500 mg) and pyrimethamine (25 mg) at each FANC visit. This is the standard regimen.
intervention type: Drug
intervention name: IPTp-SP
description: 3 tablets of sulfadoxine (500 mg) and pyrimethamine (25 mg) given at each ANC visit
arm group label: IPTp-SP
other name: Fansidar
other name: SP
intervention type: Drug
intervention name: IPTp-DP
description: At each ANC visit: treatment with Dihydroartemisinin-piperaquine for three days, with the daily number of tablets depending on the weight of the woman; two tablets for women weighing 24- 35.9kg, three tablets for women weighing 36 to 74.9 kg, and four tablets for women weighing 75kg or more. The first dose will be observed; the woman will be given the additional 2 doses to take at home and there may be a home visit to confirm that the tablets were taken.
arm group label: IPTp-DP
other name: Eurartesim
other name: Duocotexin
intervention type: Drug
intervention name: ISTp-DP
description: At each ANC visit, women will be screened for malaria using a combined HRP-2/ pLDH (P. falciparum/ pan-malaria) rapid diagnostic test, and if positive, treated with dihydroartemisinin-piperaquine. Each tablet will contain 40 mg dihydroartemisinin and 320 mg piperaquine. Treatment will be given for three days, with the daily number of tablets depending on the weight of the woman; two tablets for women weighing 24- 35.9kg, three tablets for women weighing 36 to 74.9 kg, and four tablets for women weighing 75kg or more. The first dose will be observed; the woman will be given the additional 2 doses to take at home
arm group label: ISTp-DP
other name: Eurartesim
other name: Duocotexin
criteria: 
gender: Female
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Meghna Desai, PhD MPH
role: Principal Investigator
affiliation: Centers for Disease Control and Prevention
last name: Abraham Katana, MD
role: Principal Investigator
affiliation: Kenya Medical Research Institute
facility: 
facility: 
facility: 
facility: 
country: Kenya
url: https://www.ncbi.nlm.nih.gov/pubmed/26429700
description: Publication
responsible party type: Principal Investigator
investigator affiliation: Kenya Medical Research Institute
investigator full name: Abraham Katana, MD
investigator title: Medical Officer
mesh term: Malaria
mesh term: Fanasil, pyrimethamine drug combination