<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/NCT01722539</url>
  </required_header>
  <id_info>
    <org_study_id>PIP-IPT</org_study_id>
    <nct_id>NCT01722539</nct_id>
  </id_info>
  <brief_title>Impact IPT With Sulfadoxine-pyrimethamine or Sulfadoxine-pyrimethamine Plus Piperaquine in Schoolchildren</brief_title>
  <acronym>PIP-IPT</acronym>
  <official_title>Efficacy and Safety of Sulfadoxine-pyrimethamine or Sulfadoxine-pyrimethamine Plus Piperaquine Regimens Delivered Through Intermittent Preventive Treatment in Schoolchildren of Democratic Republic of Congo: A Randomised Control Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universiteit Antwerpen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Fund for Scientific Research, Flanders, Belgium</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Kinshasa</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Universiteit Antwerpen</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Considering the facts that: (i) IPT of malaria provides substantial protection against&#xD;
      anaemia and malaria in school children (ii); SP resistance has no significant impact on the&#xD;
      prophylactic efficacy (iii) SP-PQ is safe and as efficacious as SP: the investigators&#xD;
      hypothesize that antimalarial IPT with SP and SP-PQ will improve haemoglobin concentration,&#xD;
      reduce anaemia prevalence, malaria incidence and parasitaemia, and improve malnutrition and&#xD;
      school performance in school-aged children of Congo.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      STUDY RATIONAL The education sector represents a reliable system for malaria control.&#xD;
      Intermittent preventive therapy in schoolchildren (IPTsc) is likely the most feasible and&#xD;
      appropriate chemoprevention in stable and endemic areas because schoolchildren are usually&#xD;
      asymptomatic to malaria infection and are consequently untreated in practice. Therefore, if&#xD;
      proven effective, IPTsc would be of direct benefit for the schoolchild, contribute to malaria&#xD;
      control at school, and facilitate community-wide the implementation of other control&#xD;
      interventions i.e. vector control, Intermittent preventive therapy in infants (IPTi), and&#xD;
      prompt diagnosis and treatment (PDT). Nevertheless, evidence about use of IPTsc is not yet&#xD;
      substantiated as only two clinical studies have so far been performed on IPTsc in hyper&#xD;
      endemic areas. Further clinical trials are warranted in other settings. Through a randomised&#xD;
      controlled trial (RCT) we will assess the efficacy and safety, of two IPT regimens versus&#xD;
      controls in school children of the DRCongo.&#xD;
&#xD;
      STUDY DRUGS Favourable drugs for use as IPT should balance long half-life against efficacy,&#xD;
      safety, tolerability and potentiality for cross-resistance selection.(16) Use of long-acting&#xD;
      drugs would result in fewer intake and higher treatment compliance. Sulfadoxine-pyrimethamine&#xD;
      is an established used product in the indication of IPT in pregnancy. The drug has further&#xD;
      proven safety and tolerability in children in clinical trials. SP is slowly eliminated and&#xD;
      allows 60 days antimalaria protection for fully sensitive P. falciparum. Other long-acting&#xD;
      drugs available are mefloquine, amodiaquine, and piperaquine. However, due safety concern&#xD;
      mefloquine might not be optimal for IPT. Amodiaquine is not suitable for IPT due to its 3&#xD;
      days treatment regimen that may be a concern regarding compliance. Piperaquine has been&#xD;
      extensively used for mass prophylaxis and treatment since 1978 in China and other malaria&#xD;
      endemic countries of Asia.(20) Piperaquine has a long half-live and points as good IPT&#xD;
      candidate in endemic country with SP resistance. For this study sulfadoxine-pyrimethamine&#xD;
      combined with piperaquine (SP-PQ) plus will be used. SP and SP-PQ will be given at 4 months&#xD;
      intervals in line with the long half-lives (around 20 days) in paediatric patients and for&#xD;
      higher treatment compliance,&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">November 2013</completion_date>
  <primary_completion_date type="Actual">November 2013</primary_completion_date>
  <phase>Phase 3</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>Hemoglobin change</measure>
    <time_frame>Month 0-Month 12</time_frame>
    <description>Change in mean Hb concentration at month 12 of follow-up and anaemia prevalence one year after initial preventive treatment;</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in mean Hb concentration at month 4 and 8 of follow-up</measure>
    <time_frame>Month 0 - Month 4 - Month 8</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prevalence of asymptomatic and clinical malaria at baseline &amp; one year after enrolment;</measure>
    <time_frame>Month 0 Month 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prevalence of P. falciparum dihydrofolate reductase (dhfr) and dihydropteroate synthase (dhps) gene mutations at baseline and at month 12 follow-up</measure>
    <time_frame>Month 0 - Month 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical (severe) malaria incidence and parasitaemia at month 4, 8, 12;</measure>
    <time_frame>Month 4, 8 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentages of acute and severe malnourished at month 0, 4, 8, 12 through z-scores, W/H, H/A, and skinfolds</measure>
    <time_frame>Month 0 - Month 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Educational achievement, at end of follow-up, and school attendance;</measure>
    <time_frame>Month 0 - Month 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prevalence and risk of environmental and host-related predictors for malaria (re)infections;</measure>
    <time_frame>Month 0- Month 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>adverse events</measure>
    <time_frame>Month 0- Months 12</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">616</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Sulfadoxine-Pyrimethamine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Sulfadoxine-Pyrimethamine every Four months Tablets 500 mg sulfadoxine - 25 mg pyrimethamine will be given as single oral dose of ½ tablets per 10 kg of weigh: 1 tablet for weigh less than 20 kg, 1.5 tablets in 20-29 kg, and 2 tablets for children of weigh 30 or more; Albendazole oral 200 mg will be given to children of 1-2 years and one oral dose of 400 mg to children older than 2 years. The treatment will be repeated at 4-months in the follow-up in accordance with the WHO guideline.&#xD;
Praziquantel is a tremacide used for treatment of infections due to schistosomes. Praziquantel will be given as one dose of 40 mg/kg at enrolment and at 12 months follow up.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sulfadoxine-Pyrimethamine+Piperaquine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Sulfadoxine-Pyrimethamine every 4 months Tablets 500 mg sulfadoxine - 25 mg pyrimethamine will be given as single oral dose of ½ tablets per 10 kg of weigh: 1 tablet for weigh less than 20 kg, 1.5 tablets in 20-29 kg, and 2 tablets for children of weigh 30 or more; Piperaquine every four months Piperaquine tablet 320 mg manufactured by Sigma Tau will be used at two treatment doses of 16-24 mg/kg at 24 hours intervals as follows: 1 tablets for weigh 15-19 kg, 1.5 tablets for 20-29 kg, and 2 tablets for 30-39 kg, and 2.5 tablets for 40 kg or more.&#xD;
Albendazole oral 200 mg will be given to children of 1-2 years and one oral dose of 400 mg to children older than 2 years. The treatment will be repeated at 4-months in the follow-up in accordance with the WHO guideline.&#xD;
Praziquantel is a tremacide used for treatment of infections due to schistosomes. Praziquantel will be given as one dose of 40 mg/kg at enrolment and at 12 months follow up.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Albendazole oral 200 mg will be given to children of 1-2 years and one oral dose of 400 mg to children older than 2 years. The treatment will be repeated at 4-months in the follow-up in accordance with the WHO guideline.&#xD;
Praziquantel is a tremacide used for treatment of infections due to schistosomes. Praziquantel will be given as one dose of 40 mg/kg at enrolment and at 12 months follow up.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sulfadoxine-pyrimethamine</intervention_name>
    <description>Tablets 500 mg sulfadoxine - 25 mg pyrimethamine will be given as single oral dose of ½ tablets per 10 kg of weigh: 1 tablet for weigh less than 20 kg, 1.5 tablets in 20-29 kg, and 2 tablets for children of weigh 30 or more</description>
    <arm_group_label>Sulfadoxine-Pyrimethamine</arm_group_label>
    <other_name>Fansidar</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Piperaquine</intervention_name>
    <description>Piperaquine tablet 320 mg manufactured by Sigma Tau will be used at two treatment doses of 16-24 mg/kg at 24 hours intervals as follows: 1 tablets for weigh 15-19 kg, 1.5 tablets for 20-29 kg, and 2 tablets for 30-39 kg, and 2.5 tablets for 40 kg or more.</description>
    <arm_group_label>Sulfadoxine-Pyrimethamine</arm_group_label>
    <arm_group_label>Sulfadoxine-Pyrimethamine+Piperaquine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Albendazole</intervention_name>
    <description>One oral 200 mg will be given to children of 1-2 years and one oral dose of 400 mg to children older than 2 years. The treatment will be repeated at 4-months in the follow-up in accordance with the WHO guideline.</description>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>Sulfadoxine-Pyrimethamine</arm_group_label>
    <arm_group_label>Sulfadoxine-Pyrimethamine+Piperaquine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Praziquantel</intervention_name>
    <description>Praziquantel is a tremacide used for treatment of infections due to schistosomes. Praziquantel will be given as one dose of 40 mg/kg at enrolment and at 12 months follow up.</description>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>Sulfadoxine-Pyrimethamine</arm_group_label>
    <arm_group_label>Sulfadoxine-Pyrimethamine+Piperaquine</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  males and females in primary school children,&#xD;
&#xD;
          -  anticipated local residence for the study duration,&#xD;
&#xD;
          -  signed or thumb-printed informed consent by the parents or guardians and witnessed by&#xD;
             an impartial witness (whenever parents/guardians are illiterate)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Children of the 6th primary school year&#xD;
&#xD;
          -  Participation in any other investigational drug study (antimalarial or others) during&#xD;
             the previous 30 days.&#xD;
&#xD;
          -  Known hypersensitivity or serious adverse drug reaction (ADR) to the study drugs.&#xD;
&#xD;
          -  Clinical malaria at baseline irrespectively of the severity (World Health Organisation&#xD;
             malaria treatment guideline 2010) (Annex III).&#xD;
&#xD;
          -  Febrile conditions caused by diseases other than malaria at first visit.&#xD;
&#xD;
          -  Clinical symptoms of severe anaemia&#xD;
&#xD;
          -  Illness or conditions like hematologic, cardiac, renal, hepatic diseases which in the&#xD;
             judgement of the investigator would place the subject at undue risk or interfere with&#xD;
             the results of the study, including known Glucose 6 phospahate dehydrogenase (G6PD)&#xD;
             deficiency and sickle cell (SS form).&#xD;
&#xD;
          -  Body weight &lt; 14 kg Children with major chronic infectious diseases (HIV,&#xD;
             Tuberculosis, ...)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>5 Years</minimum_age>
    <maximum_age>14 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Junior Matangila, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Kinshasa</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Pascal Lutumba, MD PhD</last_name>
    <role>Study Director</role>
    <affiliation>University of Kinshasa</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Joachim Doua, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universiteit Antwerpen</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mokali health area of Biyela health zone, in Kinshasa province.</name>
      <address>
        <city>Kinshasa</city>
        <state>Kinshasa province</state>
        <country>Congo</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Congo</country>
  </location_countries>
  <verification_date>February 2014</verification_date>
  <study_first_submitted>November 3, 2012</study_first_submitted>
  <study_first_submitted_qc>November 6, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 7, 2012</study_first_posted>
  <last_update_submitted>February 3, 2014</last_update_submitted>
  <last_update_submitted_qc>February 3, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 4, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universiteit Antwerpen</investigator_affiliation>
    <investigator_full_name>Jean-Pierre Van geertruyden</investigator_full_name>
    <investigator_title>Prof</investigator_title>
  </responsible_party>
  <keyword>intermittent</keyword>
  <keyword>preventive</keyword>
  <keyword>treatment</keyword>
  <keyword>malaria</keyword>
  <keyword>soil transmitted helminths</keyword>
  <keyword>schistosomiasis</keyword>
  <keyword>schoolchildren</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pyrimethamine</mesh_term>
    <mesh_term>Piperaquine</mesh_term>
    <mesh_term>Sulfadoxine</mesh_term>
    <mesh_term>Fanasil, pyrimethamine drug combination</mesh_term>
    <mesh_term>Albendazole</mesh_term>
    <mesh_term>Praziquantel</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/NCT01722539
org study id: PIP-IPT
nct id: NCT01722539
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
Considering the facts that: (i) IPT of malaria provides substantial protection against
      anaemia and malaria in school children (ii); SP resistance has no significant impact on the
      prophylactic efficacy (iii) SP-PQ is safe and as efficacious as SP: the investigators
      hypothesize that antimalarial IPT with SP and SP-PQ will improve haemoglobin concentration,
      reduce anaemia prevalence, malaria incidence and parasitaemia, and improve malnutrition and
      school performance in school-aged children of Congo.
STUDY RATIONAL The education sector represents a reliable system for malaria control.
      Intermittent preventive therapy in schoolchildren (IPTsc) is likely the most feasible and
      appropriate chemoprevention in stable and endemic areas because schoolchildren are usually
      asymptomatic to malaria infection and are consequently untreated in practice. Therefore, if
      proven effective, IPTsc would be of direct benefit for the schoolchild, contribute to malaria
      control at school, and facilitate community-wide the implementation of other control
      interventions i.e. vector control, Intermittent preventive therapy in infants (IPTi), and
      prompt diagnosis and treatment (PDT). Nevertheless, evidence about use of IPTsc is not yet
      substantiated as only two clinical studies have so far been performed on IPTsc in hyper
      endemic areas. Further clinical trials are warranted in other settings. Through a randomised
      controlled trial (RCT) we will assess the efficacy and safety, of two IPT regimens versus
      controls in school children of the DRCongo.

      STUDY DRUGS Favourable drugs for use as IPT should balance long half-life against efficacy,
      safety, tolerability and potentiality for cross-resistance selection.(16) Use of long-acting
      drugs would result in fewer intake and higher treatment compliance. Sulfadoxine-pyrimethamine
      is an established used product in the indication of IPT in pregnancy. The drug has further
      proven safety and tolerability in children in clinical trials. SP is slowly eliminated and
      allows 60 days antimalaria protection for fully sensitive P. falciparum. Other long-acting
      drugs available are mefloquine, amodiaquine, and piperaquine. However, due safety concern
      mefloquine might not be optimal for IPT. Amodiaquine is not suitable for IPT due to its 3
      days treatment regimen that may be a concern regarding compliance. Piperaquine has been
      extensively used for mass prophylaxis and treatment since 1978 in China and other malaria
      endemic countries of Asia.(20) Piperaquine has a long half-live and points as good IPT
      candidate in endemic country with SP resistance. For this study sulfadoxine-pyrimethamine
      combined with piperaquine (SP-PQ) plus will be used. SP and SP-PQ will be given at 4 months
      intervals in line with the long half-lives (around 20 days) in paediatric patients and for
      higher treatment compliance,
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Hemoglobin change
time frame: Month 0-Month 12
description: Change in mean Hb concentration at month 12 of follow-up and anaemia prevalence one year after initial preventive treatment;
measure: Change in mean Hb concentration at month 4 and 8 of follow-up
time frame: Month 0 - Month 4 - Month 8
measure: Prevalence of asymptomatic and clinical malaria at baseline & one year after enrolment;
time frame: Month 0 Month 12
measure: Prevalence of P. falciparum dihydrofolate reductase (dhfr) and dihydropteroate synthase (dhps) gene mutations at baseline and at month 12 follow-up
time frame: Month 0 - Month 12
measure: Clinical (severe) malaria incidence and parasitaemia at month 4, 8, 12;
time frame: Month 4, 8 12
measure: Percentages of acute and severe malnourished at month 0, 4, 8, 12 through z-scores, W/H, H/A, and skinfolds
time frame: Month 0 - Month 12
measure: Educational achievement, at end of follow-up, and school attendance;
time frame: Month 0 - Month 12
measure: Prevalence and risk of environmental and host-related predictors for malaria (re)infections;
time frame: Month 0- Month 12
measure: adverse events
time frame: Month 0- Months 12
arm group label: Sulfadoxine-Pyrimethamine
arm group type: Experimental
description: Sulfadoxine-Pyrimethamine every Four months Tablets 500 mg sulfadoxine - 25 mg pyrimethamine will be given as single oral dose of ½ tablets per 10 kg of weigh: 1 tablet for weigh less than 20 kg, 1.5 tablets in 20-29 kg, and 2 tablets for children of weigh 30 or more; Albendazole oral 200 mg will be given to children of 1-2 years and one oral dose of 400 mg to children older than 2 years. The treatment will be repeated at 4-months in the follow-up in accordance with the WHO guideline.
Praziquantel is a tremacide used for treatment of infections due to schistosomes. Praziquantel will be given as one dose of 40 mg/kg at enrolment and at 12 months follow up.
arm group label: Sulfadoxine-Pyrimethamine+Piperaquine
arm group type: Experimental
description: Sulfadoxine-Pyrimethamine every 4 months Tablets 500 mg sulfadoxine - 25 mg pyrimethamine will be given as single oral dose of ½ tablets per 10 kg of weigh: 1 tablet for weigh less than 20 kg, 1.5 tablets in 20-29 kg, and 2 tablets for children of weigh 30 or more; Piperaquine every four months Piperaquine tablet 320 mg manufactured by Sigma Tau will be used at two treatment doses of 16-24 mg/kg at 24 hours intervals as follows: 1 tablets for weigh 15-19 kg, 1.5 tablets for 20-29 kg, and 2 tablets for 30-39 kg, and 2.5 tablets for 40 kg or more.
Albendazole oral 200 mg will be given to children of 1-2 years and one oral dose of 400 mg to children older than 2 years. The treatment will be repeated at 4-months in the follow-up in accordance with the WHO guideline.
Praziquantel is a tremacide used for treatment of infections due to schistosomes. Praziquantel will be given as one dose of 40 mg/kg at enrolment and at 12 months follow up.
arm group label: Control
arm group type: Active Comparator
description: Albendazole oral 200 mg will be given to children of 1-2 years and one oral dose of 400 mg to children older than 2 years. The treatment will be repeated at 4-months in the follow-up in accordance with the WHO guideline.
Praziquantel is a tremacide used for treatment of infections due to schistosomes. Praziquantel will be given as one dose of 40 mg/kg at enrolment and at 12 months follow up.
intervention type: Drug
intervention name: Sulfadoxine-pyrimethamine
description: Tablets 500 mg sulfadoxine - 25 mg pyrimethamine will be given as single oral dose of ½ tablets per 10 kg of weigh: 1 tablet for weigh less than 20 kg, 1.5 tablets in 20-29 kg, and 2 tablets for children of weigh 30 or more
arm group label: Sulfadoxine-Pyrimethamine
other name: Fansidar
intervention type: Drug
intervention name: Piperaquine
description: Piperaquine tablet 320 mg manufactured by Sigma Tau will be used at two treatment doses of 16-24 mg/kg at 24 hours intervals as follows: 1 tablets for weigh 15-19 kg, 1.5 tablets for 20-29 kg, and 2 tablets for 30-39 kg, and 2.5 tablets for 40 kg or more.
arm group label: Sulfadoxine-Pyrimethamine
arm group label: Sulfadoxine-Pyrimethamine+Piperaquine
intervention type: Drug
intervention name: Albendazole
description: One oral 200 mg will be given to children of 1-2 years and one oral dose of 400 mg to children older than 2 years. The treatment will be repeated at 4-months in the follow-up in accordance with the WHO guideline.
arm group label: Control
arm group label: Sulfadoxine-Pyrimethamine
arm group label: Sulfadoxine-Pyrimethamine+Piperaquine
intervention type: Drug
intervention name: Praziquantel
description: Praziquantel is a tremacide used for treatment of infections due to schistosomes. Praziquantel will be given as one dose of 40 mg/kg at enrolment and at 12 months follow up.
arm group label: Control
arm group label: Sulfadoxine-Pyrimethamine
arm group label: Sulfadoxine-Pyrimethamine+Piperaquine
criteria: 
gender: All
minimum age: 5 Years
maximum age: 14 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Junior Matangila, MD
role: Principal Investigator
affiliation: University of Kinshasa
last name: Pascal Lutumba, MD PhD
role: Study Director
affiliation: University of Kinshasa
last name: Joachim Doua, MD
role: Principal Investigator
affiliation: Universiteit Antwerpen
facility: 
country: Congo
responsible party type: Principal Investigator
investigator affiliation: Universiteit Antwerpen
investigator full name: Jean-Pierre Van geertruyden
investigator title: Prof
mesh term: Pyrimethamine
mesh term: Piperaquine
mesh term: Sulfadoxine
mesh term: Fanasil, pyrimethamine drug combination
mesh term: Albendazole
mesh term: Praziquantel