A randomised, controlled, open-label, parallel-group study comparing the efficacy and safety of an oral artesunate-amodiaquine fixed-dose combination therapy over 3 subsequent days to an equivalent dose regimen of the individual drugs for the treatment of children with Plasmodium falciparum
- Conditions
- MalariaInfections and Infestations
- Registration Number
- ISRCTN07576538
- Lead Sponsor
- Drugs for Neglected Diseases initiative (DNDi) (Switzerland)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 890
1. Patient between 6 months and <5 years old
2. Bodyweight >= 5 kg (to help the assay of artesunate)
3. P. falciparum single-species infection with positive parasitemia (asexual forms) greater than 1,000 parasites per microlitre of blood
4. Fever (uncorrected axillary temperature >37.5°C) on Day 0 in children
5. No other obvious cause for the fever (e.g., respiratory [ear, nose and/or throat] infection)
6. Consent of the child's family or guardian
1. Signs of life threatening and/or severe malaria
2. Other underlying diseases (cardiac, renal, hepatic, severe malnutrition)
3. Allergy to the study drugs
4. Treatment with amodiaquine within the past 7 days, or with artemisinin derivatives within the past 3 days (72 h)
5. Complete cure with an antimalarial within the past 7 days (with the exception of chloroquine)
6. On-going treatment with an antibiotic with antimalarial action (e.g. co-trimoxazole, tetracycline, or macrolide)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method