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. 2006 Jan 25;2006(1):CD004966. doi: 10.1002/14651858.CD004966.pub2

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
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
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)
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