Chlorproguanil-Dapsone-Artesunate Versus COARTEM For Uncomplicated Malaria

Inclusion criteria:

• Acute, uncomplicated P.falciparum malaria, microscopically confirmed
• Temperature at screening of 37.5oC or or more or confirmed history of fever within previous 24 hours
• Weigh 7.5kg or over
• Screening haemoglobin (Hb) of 7g/dl or over, or haematocrit of 25% or more(If Hb not available at screening)
• Willingness to comply with the study visits and procedures, as outlined in the informed consent form
• Written or oral witnessed consent has been obtained from parent or guardian
• Assent is given by a child aged 12 years or over, in addition to the consent of their parent or guardian

Exclusion criteria:

• Features of severe/complicated falciparum malaria
• Hypersensitivity to active substances (chlorproguanil, dapsone, artesunate, artemether, lumefantrine)
• Known allergy to biguanides, sulphones, sulphonamides, artemisinin derived products or aminoalcohol drugs
• Known history of G6PD deficiency
• Infants with a history of hyperbilirubinaemia during the neonatal period
• Use of concomitant medications that may induce haemolysis or haemolytic anaemia from the WHO (World Health Organization) list of essential drugs
• Evidence of any concomitant infection at the time of presentation (including P. vivax, P. ovale and P. malariae)
• Any other underlying disease that may compromise the diagnosis and the evaluation of the response to the study medication (including clinical symptoms of immunosuppression, tuberculosis, bacterial infection; cardiac or pulmonary disease)
• Malnutrition, defined as a child whose weight-for-height is below -3 standard deviations or less than 70% of the median of the NCHS/WHO normalised reference values
• Treatment within the past three months with mefloquine or mefloquine-sulphadoxine-pyrimethamine; twenty-eight days with sulphadoxine/pyrimethamine, sulfalene/pyrimethamine, lumefantrine or artemether/lumefantrine, amodiaquine, atovaquone or atovoquone/proguanil, halofantrine; 14-days with chlorproguanil/dapsone, or 7-days with quinine (full course), proguanil, artemisinins, tetracycline doxycycline or clindamycin
• Positive sulphadoxine/pyrimethamine urine screen for 'unknown' antimalarial drug use in prior 28-days
• Use of an investigational drug within 30 days or 5 half-lives whichever is the longer
• Previous participation in this study
• Female subjects of child-bearing age, who have had a positive pregnancy test at screening, or do not give their consent to take a pregnancy test
• Female subjects who will be breast-feeding an infant for the duration of the study