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Published 21 July 2009, doi:10.1136/bmj.b2763
Cite this as: BMJ 2009;339:b2763
Jane Achan, lecturer1, James K Tibenderana, epidemiologist2, Daniel Kyabayinze, epidemiologist3, Fred Wabwire Mangen, professor4, Moses R Kamya, professor4, Grant Dorsey, professor5, Umberto DAlessandro, professor6, Philip J Rosenthal, professor5, Ambrose O Talisuna, epidemiologist4,6
1 Makerere University School of Health Sciences, PO Box 7475, Kampala, Uganda, 2 Malaria Consortium, Uganda, London School of Hygiene and Tropical Medicine, 3 COMDIS Research Programme Consortium, Malaria Consortium, Uganda, 4 Makerere University School of Health Sciences, Uganda Malaria Surveillance Project, 5 Department of Medicine University of California San Francisco, 6 Institute of Tropical Medicine, Antwerp, Belgium
Correspondence to: J Achan achanj{at}yahoo.co.uk
Design Randomised, open label effectiveness study.
Setting Outpatient clinic of Ugandas national referral hospital in Kampala.
Participants 175 children aged 6 to 59 months with uncomplicated malaria.
Interventions Participants were randomised to receive oral quinine or artemether-lumefantrine administered by care givers at home.
Main outcome measures Primary outcomes were parasitological cure rates after 28 days of follow-up unadjusted and adjusted by genotyping to distinguish recrudescence from new infections. Secondary outcomes were adherence to study drug, presence of gametocytes, recovery of haemoglobin concentration from baseline at day 28, and safety profiles.
Results Using survival analysis the cure rate unadjusted by genotyping was 96% for the artemether-lumefantrine group compared with 64% for the quinine group (hazard ratio 10.7, 95% confidence interval 3.3 to 35.5, P=0.001). In the quinine group 69% (18/26) of parasitological failures were due to recrudescence compared with none in the artemether-lumefantrine group. The mean adherence to artemether-lumefantrine was 94.5% compared with 85.4% to quinine (P=0.0008). Having adherence levels of 80% or more was associated with a decreased risk of treatment failure (0.44, 0.19 to 1.02, P=0.06). Adverse events did not differ between the two groups.
Conclusions The effectiveness of a seven day course of quinine for the treatment of uncomplicated malaria in Ugandan children was significantly lower than that of artemether-lumefantrine. These findings question the advisability of the recommendation for quinine therapy for uncomplicated malaria in Africa.
Trial registration ClinicalTrials.gov NCT00540202 [ClinicalTrials.gov] .
© Achan et al 2009
This is an open-access article distributed under the terms of the Creative Commons Attribution Non-commercial License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
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