Malaria Infections and Infestations Plasmodium falciparum malaria
Conditions
Interventions
Subjects will be randomized to receive either artemether-lumefantrine (AL) or artesunate-amodiaquine (ASAQ). Subjects who fail initial therapy will receive quinine which is the standard treatment for
Sponsors
National Malaria Control Program (Burkina Faso)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age > 6 months 2. Weight > 5 kg 3. Fever (> 37.5ºC axillary) or history of fever in the previous 24 hours 4. Absence of any history of serious side effects to study medications 5. No evidence of a concomitant febrile illness 6. Provision of informed consent and agreement to follow-up for 28 days 7. No evidence of severe malaria or danger signs 8. Absence of repeated vomiting of study medications on day 0 9. P. falciparum mono-infection 10. Parasite density > 2000/ul and < 200,000/ul
Exclusion criteria
Exclusion criteria: 1. Severe malaria 2. Unable to respect the follow-up schedule 3. Known allergy to the study medication 4. Other chronic disease requiring care
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Risk of treatment failure unadjusted and adjusted by genotyping at day 28 and tolerability | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Prevalence of fever on days 1-3 2. Prevalence of parasitemia on days 2 and 3 3. Change in mean hemoglobin level between days 0 and 28 (or day of treatment failure) 4. Prevalence of gametocytes during follow-up 5. Risk of serious adverse events during follow-up 6. Risk of adverse events of moderate or greater severity, at least possibly related to the study medications, excluding patients requiring quinine therapy 7. Selection of molecular markers associated with drug resistance | — |
Countries
Burkina Faso
Outcome results
None listed