Malaria
Conditions
Sponsors
Kwame Nkrumah University of Science and Technology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Children in 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
Exclusion criteria
Exclusion criteria: 1. Presence of severe malaria following WHO definition (see Annex 2: WHO definitions for severe falciparum malaria and danger signs) 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Day-28 efficacy of AL+AP and AL+placebo for the treatment of uncomplicated P. falciparum malaria in African children aged 6 to 59 months defined as PCR-adjusted adequate clinical and parasitological response (ACPR) excluding reinfections, in the per-protocol (PP) population. ;Day-28 efficacy of AL+AP and AL+placebo for the treatment of uncomplicated P. falciparum malaria in African children aged 6 to 59 months defined as PCR-adjusted adequate clinical and parasitological response (ACPR) excluding reinfections, in the modified intention-to-treat (mITT) population. | — |
Secondary
| Measure | Time frame |
|---|---|
| to assess types, proportion, severity and causality of adverse events (AEs) during treatment follow-up by treatment arm as measures of tolerability and safety; ;to assess day-7 lumefantrine and desbutyl-lumefantrine plasma concentrations by treatment arm; ;to estimate day-7 atovaquone, proguanil and its metabolite (cycloguanil) plasma concentrations when the treatment is AL +AP ;to assess day 3 positivity rate by treatment arm in both PP and mITT; day 3 positivity rate is defined as the proportion of patients who were still parasitaemic on day 3 after initiation of treatment;to assess PCR-unadjusted day-28 ACPR by treatment arm in both the PP and the mITT population; ;to assess PCR- adjusted and unadjusted day-42 ACPR by treatment arm in both the PP and in the mITT population; ;to assess cure rate at days 14, 21, 28, 35 and 42 by treatment arm to evaluate post-treatment prophylactic efficacy in both PP and mITT populations; | — |
Countries
Benin, Gabon, Ghana, Mali
Contacts
Public ContactJohn Amuasi
KCCR KNUST
Outcome results
None listed