Malaria Infections and Infestations Plasmodium falciparum malaria
Conditions
Interventions
Patients will be equally randomised into the following treatment groups:
1. Artesunate-amodiaquine fixed dose combination (AS/AQ FDC) (artesunate amodiaquine Winthrop® Sanofi Aventis):
1.1. Artesunat
Sponsors
Drugs for Neglected Diseases initiative (DNDi) (Switzerland)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age group of 6 and 59 months, either sex 2. Weight greater than or equal to 5 kg 3. Slide-confirmed infection with Plasmodium falciparum only (no mixed infections) 4. Asexual parasite density between 2,000 and 200,000/µl of blood, and 5. Measured axillary temperature greater than or equal to 37.5°C or history of fever in the last 48 hours, and 6. High probability of respecting the follow-up visits (residence within 1 hour walking distance from the OPD, no upcoming travel plans, etc.), and 7. Informed consent from a parent or guardian aged at least 18 years
Exclusion criteria
Exclusion criteria: 1. General danger signs according to the World Health Organization (WHO) definition 2. Signs of severe/complicated malaria according to the WHO definition 3. Severe anaemia (haemoglobin less than 5 g/dL) 4. Known history of hypersensitivity to any of the study drugs 5. Severe malnutrition (as defined by a weight-for-height below 70% of median and/or symmetrical oedemas involving at least the feet) 6. Concomitant febrile illness judged as due to causes other than malaria with the potential to confound study outcome (measles, acute lower tract respiratory infection, otitis media, tonsillitis, abscesses, severe diarrhoea with dehydration, etc; mild flu shouldn't lead to exclusion) 7. Having received already a full course of the treatment (or one of the treatments) under study in the previous 10 days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. To evaluate the efficacy of both drugs uncorrected by PCR genotyping at day 42 and to compare the re-infection rates 2. To evaluate the PCR corrected and uncorrected efficacy of amodiaquine-artesunate and artemether-lumefantrine on day 28 of follow up | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To assess the safety of amodiaquine-artesunate and artemether-lumefantrine treatment among children between 6 and 59 months old suffering from uncomplicated malaria by documenting adverse events that occurred during the study, before: 1.1. Day 28 1.2. Day 42 1.3. By documenting serious adverse events (SAE) 2. To assess inter patient absorption differences possibly influencing efficacy by measuring the pharmacokinetic (PK) of amodiaquine and lumefantrine at day 0 and day 7 | — |
Countries
Liberia
Outcome results
None listed