Randomized trial of artesunate-amodiaquine, atovaquone-proguanil, and artesunate-atovaquone-proguanil for the treatment of uncomplicated falciparum malaria in children

J Infect Dis. 2014 Dec 15;210(12):1962-71. doi: 10.1093/infdis/jiu341. Epub 2014 Jun 18.

Abstract

Background: Artemisinin-based combination therapies (ACTs) are recommended for the treatment of acute uncomplicated falciparum malaria in many malaria-endemic countries. Despite the emergence of artemisinin resistance, few alternative non-ACTs, including atovaquone-proguanil, are currently available.

Methods: Plasmodium falciparum-infected Cameroonian children ≤5 years old (n = 338) were randomly assigned to artesunate-amodiaquine, atovaquone-proguanil, or artesunate-atovaquone-proguanil treatment groups and followed for 28 days, according to the standard World Health Organization protocol. In vitro response to atovaquone and cytochrome b sequence of clinical isolates were determined.

Results: Eight late failures and 16 failures (8 late and 8 early failures) were observed after artesunate-amodiaquine and atovaquone-proguanil therapies, respectively. Most late failures were due to reinfections. Artesunate-atovaquone-proguanil was not associated with any failure. After correction by genotyping, per-protocol analysis showed no difference in the efficacy of 3 drugs. However, the proportion of atovaquone-proguanil-treated patients with positive smears on day 3 was much higher (36.0%; P < .05) than that of the artesunate-amodiaquine (2.9%) and artesunate-atovaquone-proguanil (1.0%) groups. In vitro response and cytochrome b sequence did not indicate atovaquone resistance.

Conclusions: Atovaquone-proguanil was characterized by a slow blood schizontocidal action and resulted in early treatment failure in a few patients. Artesunate-atovaquone-proguanil was a highly effective alternative treatment.

Clinical trials registration: UMIN000003813.

Keywords: Plasmodium falciparum; artemisinin; cytochrome b; drug resistance; molecular epidemiology.

Publication types

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

MeSH terms

  • Amodiaquine / therapeutic use*
  • Antimalarials / therapeutic use*
  • Artemisinins / therapeutic use*
  • Atovaquone / therapeutic use*
  • Cameroon
  • Child, Preschool
  • Cytochromes b / genetics
  • Drug Combinations
  • Drug Therapy, Combination
  • Female
  • Humans
  • Infant
  • Malaria, Falciparum / drug therapy*
  • Male
  • Parasitic Sensitivity Tests
  • Plasmodium falciparum / drug effects
  • Plasmodium falciparum / enzymology
  • Proguanil / therapeutic use*
  • Treatment Outcome

Substances

  • Antimalarials
  • Artemisinins
  • Drug Combinations
  • amodiaquine, artesunate drug combination
  • atovaquone, proguanil drug combination
  • Amodiaquine
  • Cytochromes b
  • Proguanil
  • Atovaquone