Skip to main content
. 2005 Oct 19;2005(4):CD004529. doi: 10.1002/14651858.CD004529.pub2

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%)
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
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