Borrmann 2003.
| Methods | Randomized controlled trial Length of follow up: 28 d Generation of allocation sequence: blocks of 10 and sequentially assigned to groups Allocation concealment: sealed envelopes Blinding: none Inclusion of all randomized participants in the final analysis: 170 analysed/200 randomized (85%) |
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| Participants | Number: 200 enrolled; 170 analysed, 92 for the atovaquone‐proguanil group and 78 for amodiaquine group Gender: male and female Age range: 3 to 43 months Inclusion criteria: documented uncomplicated falciparum malaria with parasitaemia between 1000 and 200,000 parasites/µL; weight between 5 kg and 11 kg; written or verbal informed consent by parent or guardian Exclusion criteria: administration of antimalarials or medications with antimalarials or haemolytic effects with previous 7 d; underlying severe diseases or concomitant infections causing fever; hypersensitivity to atovaquone, proguanil, or amodiaquine; predefined abnormal laboratory values at screening; symptoms and signs of severe malaria |
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| Interventions | 1. Atovaquone‐proguanil (fixed dose combination containing 62.5 mg atovaquone and 25 mg proguanil for 3 d) 2. Amodiaquine (10 mg/kg of a 1% suspension of amodiaquine chlorohydrate once daily for 3 d) | |
| Outcomes | 1. 28‐d cure rate 2. Parasite clearance time 3. Fever clearance time 4. Adverse events | |
| Notes | Location: Gabon Drug resistance: not stated |
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