A Randomized Controlled Trial on the Efficacy of Alternative Treatment Regimens for Uncomplicated Falciparum Malaria in a Multidrug-Resistant Falciparum Area of Bangladesh--narrowing the Options for the National Malaria Control Programme?

Trans R Soc Trop Med Hyg. Nov-Dec 2001;95(6):661-7. doi: 10.1016/s0035-9203(01)90108-7.

Abstract

We performed an open, randomized chemotherapy trial comparing the recommended first-, second- and third-line drug regimens, as well as mefloquine, for uncomplicated falciparum malaria in Bangladesh in 1996-97. The regimens were chloroquine for 3 days (CQ, Group I), quinine sulphate for 3 days followed by single-dose sulfadoxine-pyrimethamine (Q3 + SP, Group II), quinine for 7 days (Q7, Group III), and mefloquine 20 mg/kg single dose (MEF, Group IV). Subjects were symptomatic patients, aged > or = 12 years, with parasite density 500-250,000/mm3 and no history of taking antimalarials during the previous week. Drug administration was supervised and subjects were followed clinically and with blood slides in the hospital for 8 days, then as outpatients on days 14, 21 and 28. A total of 413 subjects (149, 145, 49 and 70 in Groups I-IV, respectively) completed the study. Early treatment failures (persistent or worsening clinical manifestations by day 3 confirmed with parasitological examinations) occurred only in the chloroquine group. RII and RIII parasitological failures occurred in 56%, 12%, 8% and 14% in Group I-IV, respectively. There were significantly more clinical and parasitological failures with chloroquine than with Q3 + SP, which we now recommend as a better (but far from ideal) choice for first-line therapy. The alternative compounds show parasitogical evidence of Plasmodium falciparum resistance. Further studies are needed to determine the optimum treatment for malaria in Bangladesh.

Publication types

  • Clinical Trial
  • Comparative Study
  • Randomized Controlled Trial

MeSH terms

  • Adolescent
  • Adult
  • Analysis of Variance
  • Antimalarials / administration & dosage*
  • Bangladesh
  • Child
  • Chloroquine / administration & dosage
  • Dose-Response Relationship, Drug
  • Drug Combinations
  • Drug Resistance, Multiple
  • Drug Therapy, Combination
  • Female
  • Hemoglobins / analysis
  • Humans
  • Malaria, Falciparum / blood
  • Malaria, Falciparum / prevention & control*
  • Male
  • Mefloquine / administration & dosage
  • Middle Aged
  • Pyrimethamine / administration & dosage
  • Quinine / administration & dosage
  • Sulfadoxine / administration & dosage
  • Treatment Outcome

Substances

  • Antimalarials
  • Drug Combinations
  • Hemoglobins
  • fanasil, pyrimethamine drug combination
  • Sulfadoxine
  • Chloroquine
  • Quinine
  • Mefloquine
  • Pyrimethamine