Chlorproguanil-Dapsone-Artesunate (CDA) Versus Chlorproguanil-Dapsone (LAPDAP) For Uncomplicated Malaria

This is an interventional treatment trial for Malaria, Falciparum focused on measuring Malaria CDA LAPDAP Africa Read More

Inclusion criteria:

• Acute, uncomplicated P.falciparum malaria, microscopically confirmed infection.
• Temperature at screening of 37.5oC or over or confirmed history of fever within previous 24-hours.
• Weight 7.5kg or over , no upper weight limit.
• Screening haemoglobin (Hb) of 7g/dl, or more or haematocrit of 25% or over(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 obtained from subject, parent or guardian.
• Assent is given by a child aged 12 to <18years, 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), or excipients of the investigational products.
• Known allergy to biguanides, sulphones, sulphonamides or artemisinin derived products.
• Known history of G6PD deficiency.
• Infants with a history of hyperbilirubinaemia during the neonatal period.
• Evidence of any concomitant infection at the time of presentation (including P. vivax, P. ovale and P. malariae).
• Use of concomitant medications that may induce haemolysis or haemolytic anaemia from the WHO (World Health Organization) list of essential drugs.
• 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 atovaquone/proguanil, halofantrine; 14-days with chlorproguanil/dapsone, or 7-days with quinine (full course), proguanil, artemisinin, 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 potential who have had a positive pregnancy test at enrolment, 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.