Chloroquine and Coartem for Treatment of Symptomatic Children With Plasmodium Falciparum in Guinea Bissau
Condition: Malaria, Falciparum
MeSH terms: Malaria; Malaria, Falciparum
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will evaluate the efficacy of treatment with artemether-lumefantrine as compared
      to chloroquine in the dose of 50 mg/kg for treatment of malaria in children in Guinea-Bissau.
      The genetic basis of the parasites for developing resistance will be examined. Children
      coming to one of the Health Centres with symptoms of malaria and a positive malaria test will
      be included. The children will be followed weekly until day 70. In case of reappearance of
      parasites the child will be re-treated with the opposite study drug.
    

Detailed description: 
      This study compares treatment of uncomplicated malaria in children in Guinea-Bissau with
      artemether-lumefantrine (Coartem) with that of treatment with chloroquine 50 mg/kg.
      Furthermore, the genetic basis of anti-malarial resistance in Guinea-Bissau will be studied
      by analyzing specific single nucleotide polymorphisms in pfcrt and pfmdr1 in blood samples
      from this in vivo trial. We also intend to study whether the recent report that chloroquine
      sensitive parasites are selected at recrudescence after Coartem is confirmed in Bissau.

      Following consent to participate, children visiting one of the Health Centres in the study
      area with mono-infection with Plasmodium falciparum are by block-randomization allocated to
      one of the treatment groups. The treatment is given supervised by one of the health workers
      and malaria film taken on day 2 and 3. The children are visited and malaria films obtained
      once weekly until day 70. On day seven, 100 microliter of capillary blood are drawn for
      analyses of analyses of drug concentrations in whole blood. On inclusion and whenever a child
      has recurrent parasitaemia, a filter-paper blood-sample is collected for later PCR analysis.
      On the day of inclusion, on day 42 and on day 70 the haemoglobin level is measured.

      If parasites reappear in 50% or more of at least 40 children in one of the treatment groups
      this treatment arm should be terminated. During the study parents are recommended to bring
      the child to the health centre in case of any illness. Participating children will be
      examined and treated free of charge. The opposite study drug will be used for re-treatment of
      children in case of recrudescence, and the child will be followed as previously planned.

      The results from this study could be used for the planning of the recommendations for
      treatment of malaria in Guinea-Bissau. It will provide the National Malaria Programme with
      information of the efficacy of Coartem before it is implemented.
    

Intervention name(s): Chloroquine; Artemether-lumefantrine (Coartem)
Intervention type(s): Drug; Drug
Intervention description(s): Chloroquine tablets gives as 50 mg/kg divided into 6 doses giver twice a day for 3 days.; Will be dosed according to the recommendations of WHO. Will be given at time: 0 h, 8 h, 24 h, 36 h,48 h and 60 h. The dosage will be according to bodyweight of the child as follows: 5-14 kg: 1 tablet, 15-24 kg: 2 tablets, 25-34 kg: 3 tablets, < 34 kg: 4 tablets.
Other intervention name(s): Brand name: Coartem.
Intervention MeSH terms: Chloroquine; Lumefantrine; Artemether; Artemether, Lumefantrine Drug Combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: malaria; Plasmodium falciparum; children; Guinea-Bissau; artemether; lumefantrine; chloroquine; Coartem