Malaria Infections and Infestations Plasmodium falciparum malaria
Conditions
Interventions
Patients will be equally randomised into the following treatment groups:
1. Artesunate-amodiaquine (AS-AQ Winthrop®, Sanofi-Aventis): tablet strength AS/AQ 100/270 mg. Participants will be dosed accor
Sponsors
Drugs for Neglected Diseases initiative (DNDi) (Switzerland)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged greater than or equal to 6 years, either sex 2. Weight greater than or equal to 18 kg 3. Symptoms of malaria defined as fever (axillary temperature greater than or equal to 37.5°C), or history of fever in previous 48 hours 4. Microscopic confirmation of asexual stages of P. falciparum or mixed infection 5. Willingness to attend for follow-up 6. Signed informed consent by patient or responsible caregiver
Exclusion criteria
Exclusion criteria: 1. Pregnancy (pregnancy test to be performed in women of childbearing age) 2. Severe malaria 3. AS-AQ or AL treatment at appropriate dose or more than two doses of another antimalarial in the previous 4 weeks 4. Known hypersensitivity to artemisinin derivates or amodiaquine, or artemether-lumefantrine 5. Severe anaemia (less than 5 g/dl haemoglobin) 6. Concomitant febrile illness if additional medication is required other than antipyretics
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To describe clinical tolerability of a fixed dose of AS-AQ (Winthrop® FDC) in adults and children over 6 years with uncomplicated P. falciparum malaria compared to a non-AQ containing reference therapy, i.e. artemether-lumefantrine. The clinical tolerability will be defined as the occurrence of most common adverse events. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To describe serious adverse and drug related adverse events occurring within 1 month of drug administration for both treatment 2. To assess efficacy of treatment at 28 days (polymerase chain reaction [PCR] genotyping corrected) 3. To describe day 0 and day 7 blood levels of desethyl-amodiaquine and lumefantrine | — |
Countries
Liberia
Outcome results
None listed