Malaria
Conditions
Sponsors
Kwame Nkrumah University of Science and Technology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Adults and adolescents aged 15 years and older • Body weight =40kg • Fever (=37.5°C axillary body temperature) or history of fever in the preceding 24 hours • Uncomplicated P. falciparum monoinfection with equal or more than 1,000 and less than 200,000 asexual P. falciparum parasites per µl of blood. • Signed written informed consent • Ability to comply with study procedures and follow-up schedules • Ability to take oral medication
Exclusion criteria
Exclusion criteria: • Reported intake of any antimalarial drug including halofantrine within the previous month • Intake of drugs with some antimalarial activity or that interference with tolerability assessment (including cotrimoxazole/bactrim, tetracyclines, quinolones and fluoroquinolones, and azithromycin) within the previous month • Presence of severe malaria following WHO definition (see Annex 2: WHO definitions for severe malaria) • Known history or evidence of clinically significant medical disorders • Severe malnutrition assessed by BMI • Previous participation in a malaria vaccine study • Screening haemoglobin level <7 g/dL • Known hypersensitivity or contraindications to any AL+AP components • Administration of strong inducers of CYP3A4 such as rifampin, carbamazepine, phenytoin, millepertuis/St. John’s wort (hypericum perforatum) • Known QT prolongation (e.g. hypokalaemia, hypomagnesemia) • Pregnant or lactating women • Participation in other interventional studies
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Frequency and severity of adverse events by treatment arm in general and related to the administered study drugs in adolescents and adults aged 15 years and older | — |
Secondary
| Measure | Time frame |
|---|---|
| Exploratory efficacy in terms of Adequate Clinical and Parasitological Response (ACPR) of participants treated with artemether-lumefantrine+atovaquone-proguanil and participants treated with artemether-lumefantrine for uncomplicated P. falciparum malaria | — |
Countries
Gabon
Contacts
Public ContactJohn Amuasi
KCCR KNUST
Outcome results
None listed