Lapdap and Coartemether for Uncomplicated Malaria
Condition: Malaria
MeSH terms: Malaria
Study type: Interventional
Phase: Phase 3

Summary: 
      Lapdap (chlorproguanil-dapsone) is an affordable and effective drug, but patients with
      glucose-6-phosphate dehydrogenase (G6PD) A- deficiency are more susceptible to the haemolytic
      effects of the dapsone component of Lapdap; therefore there is a need to evaluate the extent
      to which the risks associated with the use of the drug in settings without G6PD screening
      might outweigh the benefits to malaria treatment. The investigators will evaluate, in
      operational settings, the safety and effectiveness of Lapdap and coartemether
      (lumefantrine-artemether) for treatment of uncomplicated malaria in patients 6 months to 10
      years of age.
    

Detailed description: 
      Patients with uncomplicated malaria will be recruited at three health centres in the Gambia.
      Children aged 6 months to 10 years presenting with a history of illness, who have a fever or
      recent history of fever, will be screened; those with uncomplicated malaria, a positive blood
      smear with a parasite density of 500 to 200,000 parasites/µl, monoinfection with P.
      falciparum, and a packed cell volume of >=20%, will be invited to enroll into the study and
      if consent is given, will be randomized to receive three daily doses of lapdap, or a six-dose
      course of Coartem. The first dose will be given by the mother under direct observation by the
      dispensing nurse; subsequent doses will be given at home unsupervised. Children will be
      followed up actively three times; on day 3, to assess adherence to the treatment regimen, and
      on days 14 and 28, to assess parasitological and haematological recovery. The
      mother/caregiver of the child will be encouraged to bring the child to the clinic if the
      child does not improve or if she is concerned about the child's health. On day 3, the
      parent/caregiver will be visited at home (after the last dose should have been taken) in
      order to check for any leftover medication, and to ask about compliance and adverse
      reactions. A finger prick blood sample will be taken for Hb measurement by haemocue in the
      field and for a filter paper sample for measurement of drug concentration. The investigators
      will employ a longitudinal randomized design, whereby subsequent episodes of malaria will be
      treated according to the original randomization. This will enable better assessment of
      cumulative effects of repeated treatments on anaemia and on tolerability. Since patients with
      glucose-6-phosphate dehydrogenase (G6PD) A- deficiency are more susceptible to the haemolytic
      effects of the dapsone component of Lapdap, the investigators will determine the G6PD
      genotype and enzymatic activity, in order to evaluate the extent to which the risks
      associated with the use of the drug in settings without G6PD screening might outweigh the
      benefits to malaria treatment.
    

Intervention name(s): Chlorproguanil-dapsone (Lapdap); Lumefantrine-artemether (Coartemether )
Intervention type(s): Drug; Drug
Intervention MeSH terms: Lumefantrine; Artemether; Dapsone; Chlorproguanil; Artemether, Lumefantrine Drug Combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: uncomplicated malaria; G6PD deficiency; haemolytic anaemia; Lapdap; Artemsinin based combination treatment; compliance; pragmatic trials