A multicentre phase III trial to evaluate the safety, tolerabilty, and efficacy of a combination of three antimalaria drugs (artemether-lumefantrine+atovaquone-proguanil) versus two malaria drugs (artemether-lumefantrine) +placebo in African children aged 6-59months with an uncomplicated malaria infectio
- Conditions
- Treatment of uncomplicated malaria in African children aged 6 to 59 monthsInfections and Infestations
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 1664
1. Children between the age of 6 to 59 months
2. Body weight =5.0kg
3. Fever (=37.5°C axillary or 38.0°C oral, rectal or tympanic body temperature) or history of fever in the preceding 24 hours
4. Uncomplicated P. falciparum mono-infection with equal or more than 1,000 and less than 200,000 asexual P. falciparum parasites per microliter of blood.
5. Signed written informed consent from the child’s legal representative
6. Ability to comply with study procedures and follow-up schedules
7. Willing to stay in study area during the period of follow-up
8. Ability to take oral medication
1. Presence of severe malaria following WHO definition
2. Reported intake of any antimalarial drug within the previous 28 days
3. Intake of drugs with antimalarial activity or contraindicated drugs within the previous 28 days
4. Administration of strong inducers or inhibitors of CYP3A4 such as rifampin, carbamazepine, phenytoin, millepertuis/St. John’s wort/
hypericum perforatum, grapefruit within the previous 28 days
5. Known history or evidence of clinically significant medical disorders as determined by the investigator
6. Severe malnutrition assessed by middle upper arm circumference (< 115 mm) according to WHO standard
7. Screening hemoglobin level <7 g/dL
8. Known hypersensitivity or contraindications to any AL and/or AP components
9. Known QT prolongation
10. Previous participation in a malaria vaccine study
11. Participation in the ASAAP study during the previous 42 days
12. Participation in other interventional studies within the previous 28 days
13. Patients that the investigator considers would be at particular risk if participating in the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Day-28 efficacy of treatment defined as PCR-adjusted adequate clinical and parasitological response (ACPR) excluding reinfections, in the per-protocol (PP) population. 2. Day-28 efficacy of treatment defined as PCR-adjusted ACPR excluding reinfections, in the modified intention-to-treat (mITT) population.
- Secondary Outcome Measures
Name Time Method