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Randomized Trial of Piperaquine with Sulfadoxine-Pyrimethamine or Dihydroartemisinin for Malaria Intermittent Preventive Treatment in Children

Author

Listed:
  • Badara Cisse
  • Matthew Cairns
  • Ernest Faye
  • Ousmane NDiaye
  • Babacar Faye
  • Cecile Cames
  • Yue Cheng
  • Maguette NDiaye
  • Aminata Collé Lô
  • Kirsten Simondon
  • Jean-Francois Trape
  • Oumar Faye
  • Jean Louis NDiaye
  • Oumar Gaye
  • Brian Greenwood
  • Paul Milligan

Abstract

Background: The long terminal half life of piperaquine makes it suitable for intermittent preventive treatment for malaria but no studies of its use for prevention have been done in Africa. We did a cluster randomized trial to determine whether piperaquine in combination with either dihydroartemisin (DHA) or sulfadoxine-pyrimethamine (SP) is as effective, and better tolerated, than SP plus amodiaquine (AQ), when used for intermittent preventive treatment in children delivered by community health workers in a rural area of Senegal. Methods: Treatments were delivered to children 3–59 months of age in their homes once per month during the transmission season by community health workers. 33 health workers, each covering about 60 children, were randomized to deliver either SP+AQ, DHA+PQ or SP+PQ. Primary endpoints were the incidence of attacks of clinical malaria, and the incidence of adverse events. Results: 1893 children were enrolled. Coverage of monthly rounds and compliance with daily doses was similar in all groups; 90% of children received at least 2 monthly doses. Piperaquine combinations were better tolerated than SP+AQ with a significantly lower risk of common, mild adverse events. 103 episodes of clinical malaria were recorded during the course of the trial. 68 children had malaria with parasitaemia >3000/µL, 29/671 (4.3%) in the SP+AQ group, compared with 22/604 (3.6%) in the DHA+PQ group (risk difference 0.47%, 95%CI −2.3%,+3.3%), and 17/618 (2.8%) in the SP+PQ group (risk difference 1.2%, 95%CI −1.3%,+3.6%). Prevalences of parasitaemia and the proportion of children carrying Pfdhfr and Pfdhps mutations associated with resistance to SP were very low in all groups at the end of the transmission season. Conclusions: Seasonal IPT with SP+PQ in children is highly effective and well tolerated; the combination of two long-acting drugs is likely to impede the emergence of resistant parasites. Trial Registration: ClinicalTrials.gov NCT00529620

Suggested Citation

  • Badara Cisse & Matthew Cairns & Ernest Faye & Ousmane NDiaye & Babacar Faye & Cecile Cames & Yue Cheng & Maguette NDiaye & Aminata Collé Lô & Kirsten Simondon & Jean-Francois Trape & Oumar Faye & Jean, 2009. "Randomized Trial of Piperaquine with Sulfadoxine-Pyrimethamine or Dihydroartemisinin for Malaria Intermittent Preventive Treatment in Children," PLOS ONE, Public Library of Science, vol. 4(9), pages 1-10, September.
    • Handle: RePEc:plo:pone00:0007164
    DOI: 10.1371/journal.pone.0007164
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    References listed on IDEAS

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    1. Cheikh Sokhna & Badara Cissé & El Hadj Bâ & Paul Milligan & Rachel Hallett & Colin Sutherland & Oumar Gaye & Denis Boulanger & Kirsten Simondon & François Simondon & Geoffrey Targett & Jo Lines & Bria, 2008. "A Trial of the Efficacy, Safety and Impact on Drug Resistance of Four Drug Regimens for Seasonal Intermittent Preventive Treatment for Malaria in Senegalese Children," PLOS ONE, Public Library of Science, vol. 3(1), pages 1-9, January.
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