Randomized, double-blind, placebo-controlled trial of monthly versus bimonthly dihydroartemisinin-piperaquine chemoprevention in adults at high risk of malaria

Antimicrob Agents Chemother. 2012 Mar;56(3):1571-7. doi: 10.1128/AAC.05877-11. Epub 2012 Jan 17.

Abstract

Intermittent preventive treatment (IPT) is increasingly used to reduce malaria morbidity and mortality in children and pregnant women. The efficacy of IPT depends on the pharmacokinetic and pharmacodynamic properties of the antimalarial drugs used. Healthy adult male volunteers whose occupation put them at high risk of malaria on the Northwest border of Thailand were randomized to receive a 3-day-treatment dose of dihydroartemisinin-piperaquine monthly (DPm) or every 2 months (DPalt) or an identical placebo with or without fat (6.4 g/dose) over a 9-month period. All volunteers were monitored weekly. One thousand adults were recruited. Dihydroartemisinin-piperaquine was well tolerated. There were 114 episodes of malaria (49 Plasmodium falciparum, 63 P. vivax, and 2 P. ovale). The protective efficacy against all malaria at 36 weeks was 98% (95% confidence interval [CI], 96% to 99%) in the DPm group and 86% (95% CI, 81% to 90%) in the DPalt group (for both, P < 0.0001 compared to the placebo group). As a result, the placebo group also had lower hematocrits during the study (P < 0.0001). Trough plasma piperaquine concentrations were the main determinant of efficacy; no malaria occurred in participants with a trough concentration above 31 ng/ml. Neither plasma piperaquine concentration nor efficacy was influenced by the coadministration of fat. DPm is safe to use and is effective in the prevention of malaria in adult males living in an area where P. vivax and multidrug-resistant P. falciparum malaria are endemic.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Antimalarials / administration & dosage
  • Antimalarials / therapeutic use*
  • Artemisinins / administration & dosage
  • Artemisinins / therapeutic use*
  • Chemoprevention
  • Dietary Fats / administration & dosage
  • Double-Blind Method
  • Drug Administration Schedule
  • Drug Therapy, Combination
  • Hematocrit
  • Humans
  • Malaria, Falciparum / parasitology
  • Malaria, Falciparum / prevention & control*
  • Malaria, Vivax / parasitology
  • Malaria, Vivax / prevention & control*
  • Male
  • Middle Aged
  • Placebos
  • Plasmodium falciparum / drug effects*
  • Plasmodium falciparum / physiology
  • Plasmodium vivax / drug effects*
  • Plasmodium vivax / physiology
  • Quinolines / administration & dosage
  • Quinolines / therapeutic use*
  • Risk
  • Thailand

Substances

  • Antimalarials
  • Artemisinins
  • Dietary Fats
  • Placebos
  • Quinolines
  • artenimol
  • piperaquine

Associated data

  • ISRCTN/ISRCTN65524939