Comparative study of the effectiveness and pharmacokinetics of two rectal artesunate/oral mefloquine combination regimens for the treatment of uncomplicated childhood falciparum malaria

Ann Trop Paediatr. 2007 Mar;27(1):17-24. doi: 10.1179/146532807X170466.

Abstract

Background: Rectal artesunate has been shown to be an effective treatment for falciparum malaria and is useful in patients who cannot take medicine orally or when parenteral medication is inconvenient. A combination with mefloquine can decrease the duration of treatment, increase compliance and delay development of resistance. There are no clear data on whether a higher dosage of rectal artesunate results in a better clinical response.

Aim: To assess two rectal artesunate/oral mefloquine regimens for treating uncomplicated multi-drug-resistant childhood falciparum malaria.

Methods: Seventy children aged 1-14 years with uncomplicated falciparum malaria were randomly assigned to receive either 10 (range 8-12) or 20 (range 16-24) mg/kg/day rectal artesunate for 3 days followed by 25 mg/kg oral mefloquine. The study endpoints were fever clearance time, parasite clearance time and proportion of patients with recrudescence. Serum levels of artesunate and dihydro-artemisinin were measured after the first dose of rectal artesunate in 16 subjects.

Results: Both regimens were safe and effective. The cure rate was 100% in the 53 patients who completed 28-day follow-up. All of the study endpoints were comparable between both treatment groups.

Conclusion: A regimen of rectal artesunate 10 mg/kg/day for 3 days followed by mefloquine 25 mg/kg is optimal for the treatment of uncomplicated falciparum malaria. There was no definite benefit from increasing the dosage of rectal artesunate from 10 to 20 mg/kg/day.

Publication types

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

MeSH terms

  • Administration, Oral
  • Administration, Rectal
  • Adolescent
  • Antimalarials / administration & dosage*
  • Antimalarials / adverse effects
  • Antimalarials / blood
  • Artemisinins / administration & dosage*
  • Artemisinins / adverse effects
  • Artemisinins / blood
  • Artesunate
  • Body Weight
  • Child
  • Child, Preschool
  • Drug Administration Schedule
  • Drug Therapy, Combination
  • Female
  • Humans
  • Infant
  • Malaria, Falciparum / blood
  • Malaria, Falciparum / drug therapy*
  • Malaria, Falciparum / parasitology
  • Male
  • Mefloquine / administration & dosage*
  • Mefloquine / adverse effects
  • Mefloquine / blood
  • Sesquiterpenes / administration & dosage*
  • Sesquiterpenes / adverse effects
  • Sesquiterpenes / blood
  • Single-Blind Method
  • Treatment Outcome

Substances

  • Antimalarials
  • Artemisinins
  • Sesquiterpenes
  • Artesunate
  • Mefloquine