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Efficacy, Safety, and Tolerability of Three Regimens for Prevention of Malaria: A Randomized, Placebo-Controlled Trial in Ugandan Schoolchildren

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  • Joaniter Nankabirwa
  • Bonnie Cundill
  • Sian Clarke
  • Narcis Kabatereine
  • Philip J Rosenthal
  • Grant Dorsey
  • Simon Brooker
  • Sarah G Staedke

Abstract

Background: Intermittent preventive treatment (IPT) is a promising malaria control strategy; however, the optimal regimen remains unclear. We conducted a randomized, single-blinded, placebo-controlled trial to evaluate the efficacy, safety, and tolerability of a single course of sulfadoxine-pyrimethamine (SP), amodiaquine + SP (AQ+SP) or dihydroartemisinin-piperaquine (DP) among schoolchildren to inform IPT. Methods: Asymptomatic girls aged 8 to 12 years and boys aged 8 to 14 years enrolled in two primary schools in Tororo, Uganda were randomized to receive one of the study regimens or placebo, regardless of presence of parasitemia at enrollment, and followed for 42 days. The primary outcome was risk of parasitemia at 42 days. Survival analysis was used to assess differences between regimens. Results: Of 780 enrolled participants, 769 (98.6%) completed follow-up and were assigned a treatment outcome. The risk of parasitemia at 42 days varied significantly between DP (11.7% [95% confidence interval (CI): 7.9, 17.1]), AQ+SP (44.3% [37.6, 51.5]), and SP (79.7% [95% CI: 73.6, 85.2], p

Suggested Citation

  • Joaniter Nankabirwa & Bonnie Cundill & Sian Clarke & Narcis Kabatereine & Philip J Rosenthal & Grant Dorsey & Simon Brooker & Sarah G Staedke, 2010. "Efficacy, Safety, and Tolerability of Three Regimens for Prevention of Malaria: A Randomized, Placebo-Controlled Trial in Ugandan Schoolchildren," PLOS ONE, Public Library of Science, vol. 5(10), pages 1-9, October.
    • Handle: RePEc:plo:pone00:0013438
    DOI: 10.1371/journal.pone.0013438
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    1. Moses R Kamya & Adoke Yeka & Hasifa Bukirwa & Myers Lugemwa & John B Rwakimari & Sarah G Staedke & Ambrose O Talisuna & Bryan Greenhouse & François Nosten & Philip J Rosenthal & Fred Wabwire-Mangen & , 2007. "Artemether-Lumefantrine versus Dihydroartemisinin-Piperaquine for Treatment of Malaria: A Randomized Trial," PLOS Clinical Trials, Public Library of Science, vol. 2(5), pages 1-9, May.
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    Cited by:

    1. Emmanuel Arinaitwe & Veronica Ades & Andrew Walakira & Boaz Ninsiima & Olive Mugagga & Teja S Patil & Alanna Schwartz & Moses R Kamya & Sussann Nasr & Michelle Chang & Scott Filler & Grant Dorsey, 2013. "Intermittent Preventive Therapy with Sulfadoxine-Pyrimethamine for Malaria in Pregnancy: A Cross-Sectional Study from Tororo, Uganda," PLOS ONE, Public Library of Science, vol. 8(9), pages 1-6, September.

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