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Dihydroartemisinin-Piperaquine and Artemether-Lumefantrine for Treating Uncomplicated Malaria in African Children: A Randomised, Non-Inferiority Trial

Author

Listed:
  • Quique Bassat
  • Modest Mulenga
  • Halidou Tinto
  • Patrice Piola
  • Steffen Borrmann
  • Clara Menéndez
  • Michael Nambozi
  • Innocent Valéa
  • Carolyn Nabasumba
  • Philip Sasi
  • Antonella Bacchieri
  • Marco Corsi
  • David Ubben
  • Ambrose Talisuna
  • Umberto D'Alessandro

Abstract

Background: Artemisinin combination therapies (ACTs) are currently the preferred option for treating uncomplicated malaria. Dihydroartemisinin-piperaquine (DHA-PQP) is a promising fixed-dose ACT with limited information on its safety and efficacy in African children. Methodology/Principal Findings: The non-inferiority of DHA-PQP versus artemether-lumefantrine (AL) in children 6–59 months old with uncomplicated P. falciparum malaria was tested in five African countries (Burkina Faso, Kenya, Mozambique, Uganda and Zambia). Patients were randomised (2∶1) to receive either DHA-PQP or AL. Non-inferiority was assessed using a margin of −5% for the lower limit of the one-sided 97.5% confidence interval on the treatment difference (DHA-PQP vs. AL) of the day 28 polymerase chain reaction (PCR) corrected cure rate. Efficacy analysis was performed in several populations, and two of them are presented here: intention-to-treat (ITT) and enlarged per-protocol (ePP). 1553 children were randomised, 1039 receiving DHA-PQP and 514 AL. The PCR-corrected day 28 cure rate was 90.4% (ITT) and 94.7% (ePP) in the DHA-PQP group, and 90.0% (ITT) and 95.3% (ePP) in the AL group. The lower limits of the one-sided 97.5% CI of the difference between the two treatments were −2.80% and −2.96%, in the ITT and ePP populations, respectively. In the ITT population, the Kaplan-Meier estimate of the proportion of new infections up to Day 42 was 13.55% (95% CI: 11.35%–15.76%) for DHA-PQP vs 24.00% (95% CI: 20.11%–27.88%) for AL (p

Suggested Citation

  • Quique Bassat & Modest Mulenga & Halidou Tinto & Patrice Piola & Steffen Borrmann & Clara Menéndez & Michael Nambozi & Innocent Valéa & Carolyn Nabasumba & Philip Sasi & Antonella Bacchieri & Marco Co, 2009. "Dihydroartemisinin-Piperaquine and Artemether-Lumefantrine for Treating Uncomplicated Malaria in African Children: A Randomised, Non-Inferiority Trial," PLOS ONE, Public Library of Science, vol. 4(11), pages 1-10, November.
    • Handle: RePEc:plo:pone00:0007871
    DOI: 10.1371/journal.pone.0007871
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    1. Tanilu Grande & Andrea Bernasconi & Annette Erhart & Dioni Gamboa & Martin Casapia & Christopher Delgado & Kathy Torres & Caterina Fanello & Alejandro Llanos-Cuentas & Umberto D'Alessandro, 2007. "A Randomised Controlled Trial to Assess the Efficacy of Dihydroartemisinin-Piperaquine for the Treatment of Uncomplicated Falciparum Malaria in Peru," PLOS ONE, Public Library of Science, vol. 2(10), pages 1-7, October.
    2. 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.
    3. Adoke Yeka & Grant Dorsey & Moses R Kamya & Ambrose Talisuna & Myers Lugemwa & John Bosco Rwakimari & Sarah G Staedke & Philip J Rosenthal & Fred Wabwire-Mangen & Hasifa Bukirwa, 2008. "Artemether-Lumefantrine versus Dihydroartemisinin-Piperaquine for Treating Uncomplicated Malaria: A Randomized Trial to Guide Policy in Uganda," PLOS ONE, Public Library of Science, vol. 3(6), pages 1-7, June.
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