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

Rwagacondo 2003.

Methods Randomized open trial
Generation of allocation sequence: not mentioned
Allocation concealment: not mentioned
Blinding: not mentioned
Inclusion of all randomized participants: no (275/276)
Length of follow up: 28 days
Participants Number: 276 children enrolled
Inclusion criteria: children 6 to 59 months old; fever, temperature at least 37.5 ºC; weight at least 5 kg; parasitaemia 1000 to 100,000 asexual parasites/µL of blood; Plasmodium falciparum pure infection; parent or guardian written informed consent
Exclusion criteria: danger signs (not able to drink or breastfeed; vomiting > 2 times in 24 hours; recent history of convulsions; unconscious state or unable to sit or stand; signs of severe malaria; a packed cell volume < 15%; a clear history of adequate malaria treatment in the preceding 72 h; or evidence of chronic disease
Interventions 1. Sulfadoxine‐pyrimethamine (SP) plus amodiaquine (AQ)
 2. SP plus artesunate (AS)
AQ: 10 mg/kg/day for 3 days
AS: 4 mg/kg/day for 3 days
SP: 25 mg/kg sulfadoxine and 1.25 mg/kg pyrimethamine
Third arm not relevant to review: AQ alone
Outcomes 1. Treatment failure at day 28 both adjusted and unadjusted for new infections 
 2. Mentions adverse events but did not report any
Notes Location: Rwanda in 3 sites of Kicukiro, Rukara and Mashesha health centres
Date: May to August 2001
Funding: Belgian Development Co‐operation (DGIS) in collaboration with the Prince Leopold Institute of Tropical Medicine (Antwerp, Belgium)