Malaria (P.falciparum) Infections and Infestations Malaria (P. falciparum)
Conditions
Interventions
Subjects will be randomised to treatment with AL or DP. Subjects in the DP arm will also receive placebo tablets to ensure that the number of doses received is identical in the two treatment groups.
Sponsors
Uganda Malaria Surveillance Project (Uganda)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged six months to ten years 2. Weight more than 5 kg 3. Fever (more than 37.5°C axillary) or history of fever in the previous 24 hours 4. Provision of informed consent and agreement to follow-up for 42 days 5. Plasmodium falciparum mono-infection 6. Parasite density more than 2000/µl and less than 200,000/µl
Exclusion criteria
Exclusion criteria: 1. Previously enrolled in this study 2. History of serious side effects to study medications 3. Evidence of a concomitant febrile illness 4. Evidence of severe malaria or danger signs 5. Repeated vomiting of study medications on day zero
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Risk of treatment failure unadjusted and adjusted by genotyping at day 42 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Prevalence of fever on days one to three 2. Prevalence of parasitemia on days two and three 3. Change in mean hemoglobin level between days zero and 42 (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
Uganda, United States of America
Outcome results
None listed