Sulfadoxine-pyrimethamine plus artesunate compared with chloroquine for the treatment of vivax malaria in areas co-endemic for Plasmodium falciparum and P. vivax: a randomised non-inferiority trial in eastern Afghanistan

Trans R Soc Trop Med Hyg. 2007 Nov;101(11):1081-7. doi: 10.1016/j.trstmh.2007.06.015. Epub 2007 Aug 17.

Abstract

Chloroquine (CQ) is an effective treatment of choice for vivax malaria in most settings, but with the spread of CQ-resistant Plasmodium falciparum, many countries now use artemisinin-based combination therapy for treatment of falciparum malaria. In areas co-endemic for falciparum and vivax malaria incorrect differential diagnosis is always a risk. In Afghanistan the adoption of sulfadoxine-pyrimethamine plus artesunate (SP+AS) as first-line falciparum treatment raises the prospect of a significant proportion of vivax malaria being misdiagnosed and treated with the combination. SP is considered to have limited efficacy against vivax malaria, and the efficacy of SP+AS against Plasmodium vivax has not been established in areas that are using SP+AS. A randomised, non-inferiority trial comparing SP+AS with CQ monotherapy was undertaken on 190 vivax malaria patients in eastern Afghanistan. Standard WHO procedures for in vivo evaluation of antimalarial drugs were followed. A total of 180 individuals completed the trial to day 42. Using a per protocol analysis, both regimens resulted in > or =96% treatment success at 28 d, but significantly more cases failed in the CQ arm (46%) than in the SP+AS arm (24%) by day 42. In areas where vivax infections might be misdiagnosed as falciparum infections and treated with SP+AS, patient management would be as good, or better than, with the standard CQ treatment.

Trial registration: ClinicalTrials.gov NCT00486694.

Publication types

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

MeSH terms

  • Adolescent
  • Afghanistan / epidemiology
  • Antimalarials / therapeutic use*
  • Artemisinins / therapeutic use*
  • Artesunate
  • Child
  • Chloroquine / therapeutic use*
  • Drug Combinations
  • Drug Resistance
  • Drug Therapy, Combination
  • Endemic Diseases
  • Humans
  • Malaria, Falciparum / drug therapy*
  • Malaria, Falciparum / epidemiology
  • Malaria, Vivax / drug therapy*
  • Malaria, Vivax / epidemiology
  • Pyrimethamine / therapeutic use*
  • Sesquiterpenes / therapeutic use*
  • Sulfadoxine / therapeutic use*
  • Treatment Outcome

Substances

  • Antimalarials
  • Artemisinins
  • Drug Combinations
  • Sesquiterpenes
  • fanasil, pyrimethamine drug combination
  • Artesunate
  • Sulfadoxine
  • Chloroquine
  • Pyrimethamine

Associated data

  • ClinicalTrials.gov/NCT00486694