Artemisinin-based combination therapy for ... - The Cochrane Library

Dorsey 2006 UGA
Methods Trial design: A 3-arm, single blind (outcome assessors) randomized controlled trial. An
unusual design where participants were randomized to a treatment and followed up
through however many episodes of malaria happened to occur during the time period.
Follow up: Days 0, 1, 2, 3, 7, 14, and 28 or any other day they became ill, for a
standardized history, examination and malaria film. Anthelminthics, iron sulphate, and
vitamin A were prescribed as per IMCI guidelines.
Participants with P. vivax during follow up were censored on day of occurrence
Adverse event monitoring: Assessed at each follow-up visit, an adverse event defined as
any untoward medical occurrence. Complete blood count and alanine aminotransferase
on day 0 and 14.
Participants Number: 329 children randomized to a treatment group
Inclusion criteria: Age 1 to 10 yrs, weight >10 kg, agreement to remain in Kampala,
agreement to attend the study clinic for any febrile illness, agreement to avoid medications
outside of the study, informed consent
Exclusion criteria: Known adverse reactions to study meds, severe malnutrition, known
serious chronic disease, life threatening lab results on screening
Interventions 1. Artemether-lumefantrine, fixed dose combination, 20 mg/120 mg tablets
• 5 to 14 kg 1 tablet twice daily for 3 days
• 15 to 24 kg 2 tablets twice daily for 3 days
• 25 to 34 kg 3 tablets twice daily for 3 days
2. Artesunate plus amodiaquine, loose combination
• AS 4 mg/kg once daily for 3 days
• AQ 10 mg/kg on days 0 and 1 and 5 mg/kg on day 2
• Plus placebo in the evenings
3. Amodiaquine plus sulfadoxine-pyrimethamine, loose combination
• AQ 10 mg/kg on days 0 and 1 and 5 mg/kg on day 2
• SP 25/1.25 mg/kg on day 1
• Plus placebo in the evenings
Only the first dose was supervized each day
Outcomes 1. Risk of treatment failure at day 28, PCR adjusted and unadjusted
2. Recurrent malaria caused by non-falciparum species
3. Gametocyte carriage by day of follow up
4. Mean change in haemoglobin from baseline to day 14
5. Adverse events
Not included in the review:
1. Fever clearance
2. Parasite clearance
Notes Country: Uganda
Setting: Urban clinic
Transmission: Mesoendemic with peaks during the 2 rainy seasons
Resistance: CQ, AQ and SP resistance
Dates: Nov 2004 to June 2006
Funding: National Institutes of Health, Doris Duke Charitable Foundation
Risk of bias
Artemisinin-based combination therapy for treating uncomplicated malaria (Review)
Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
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