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  3. Effectiveness of quinine versus artemether-lumefantrine for treating uncomplicated falciparum malaria in Ugandan children: randomised trial
Research

Effectiveness of quinine versus artemether-lumefantrine for treating uncomplicated falciparum malaria in Ugandan children: randomised trial

BMJ 2009; 339 doi: https://doi.org/10.1136/bmj.b2763 (Published 21 July 2009) Cite this as: BMJ 2009;339:b2763
  1. Jane Achan, lecturer1,
  2. James K Tibenderana, epidemiologist2,
  3. Daniel Kyabayinze, epidemiologist3,
  4. Fred Wabwire Mangen, professor4,
  5. Moses R Kamya, professor4,
  6. Grant Dorsey, professor5,
  7. Umberto D’Alessandro, professor6,
  8. Philip J Rosenthal, professor5,
  9. Ambrose O Talisuna, epidemiologist46
  1. 1Makerere University School of Health Sciences, PO Box 7475, Kampala, Uganda
  2. 2Malaria Consortium, Uganda, London School of Hygiene and Tropical Medicine
  3. 3COMDIS Research Programme Consortium, Malaria Consortium, Uganda
  4. 4Makerere University School of Health Sciences, Uganda Malaria Surveillance Project
  5. 5Department of Medicine University of California San Francisco
  6. 6Institute of Tropical Medicine, Antwerp, Belgium
  1. Correspondence to: J Achan achanj{at}yahoo.co.uk
  • Accepted 8 April 2009

Abstract

Objective To compare the effectiveness of oral quinine with that of artemether-lumefantrine in treating uncomplicated malaria in children.

Design Randomised, open label effectiveness study.

Setting Outpatient clinic of Uganda’s 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.

Footnotes

  • We thank the care givers for giving consent, the children for their cooperation, the study team, and Vinay Gupta and Bryan Greenhouse for assistance with genotyping of clinical samples.

  • Contributors: AJ devised the study, was involved in protocol development, implementation of the trial, data analysis, and drafting the manuscript. JKT devised the study, obtained funding, and was involved in protocol development and manuscript production. DK was involved in protocol development, implementation of the trial, and reviewing the manuscript. AOT devised the study, was involved in protocol development and manuscript production and is the guarantor. PJR was involved in implementation of the trial, interpretation of data, and drafting and reviewing the manuscript. GD was involved in data analysis and interpretation and reviewing the manuscript. UD’A was involved in protocol development and reviewing the manuscript. MRK and FWM were involved in reviewing the manuscript. JA and PJR wrote the first draft of the manuscript and all authors contributed to the final version of the paper.

  • Funding: This study received funding from the Department for International Development (DFID), UK, through the Malaria Consortium (contract No CNTR 04 5432). The sponsors of the study had no role in study design, data collection, data analysis, data interpretation or writing of this report. The corresponding author had full access to study data and had final responsibility for submission for publication. All authors reviewed the manuscript and agreed to its content.

  • Competing interests: None declared.

  • Ethical approval: This study was approved by the Makerere University Faculty of Medicine research and ethics committee and Uganda National Council for Science and Technology. All primary care givers provided written informed consent.

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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