Mockenhaupt 2005.
Methods | Randomized placebo controlled trial Generation of allocation sequence: computer‐generated block randomization Allocation concealment: not mentioned Blinding: participants, not clear whom else Inclusion of all randomized participants: no (264/293) Length of follow up: 28 days |
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Participants | Number: 293 enrolled, 273 analysed at day 14, and 264 analysed at day 28 Inclusion criteria: children 6 to 59 months attending Bulpeila Health Centre; mono‐infection with Plasmodium falciparum; parasitaemia 2000 to 100,000 asexual parasites/µL of blood; axillary temperature at least 37.5 ºC; body weight > 5 kg; absence of severe malnutrition; no other causes of febrile illness; no danger signs and no severe and complicated malaria; haemoglobin at least 5 g/dL; and parent or guardian written informed consent Exclusion criteria: known hypersensitivity to study drugs; detection during follow up of mixed malarial infections; and development of concomitant disease which would interfere with classification of treatment outcome |
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Interventions | 1. Sulfadoxine‐pyrimethamine (SP) plus amodiaquine (AQ)
2. SP plus artesunate (AS) AQ: 10 mg/kg/day for 3 days plus AS placebo AS: 4 mg/kg/day for 3 days plus AQ placebo SP: 25 mg/kg sulfadoxine and 1.25 mg/kg pyrimethamine; single dose Third arm not relevant to review: SP alone (plus AQ and AS placebos once a day for 3 days) |
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Outcomes | 1. Treatment failure according to the World Health Organization (WHO) classification; at day 28 both adjusted and unadjusted for new infections 2. Presence of malaria parasites at various time points up to day 28 3. Presence of fever at various time points up to day 28 4. Gametocyte prevalence at day 7 | |
Notes | Location: Tamale, Northern Region, Ghana Date: August to December 2002 Funding: World Health Organization; Dafra Pharma (Belgium) and Park‐Davis (Senegal) provided study medication |