Chlorproguanil-Dapsone-Artesunate Versus COARTEM For Uncomplicated Malaria
Malaria, Falciparum
About this trial
This is an interventional treatment trial for Malaria, Falciparum focused on measuring Malaria CDA COARTEM Africa pediatrics children
Eligibility Criteria
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
Sites / Locations
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
Arms of the Study
Arm 1
Experimental
Arm 1