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 |
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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 |
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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 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 |
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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) |