Mefloquine compared with doxycycline for the prophylaxis of malaria in Indonesian soldiers. A randomized, double-blind, placebo-controlled trial

Ann Intern Med. 1997 Jun 15;126(12):963-72. doi: 10.7326/0003-4819-126-12-199706150-00006.

Abstract

Background: Mefloquine and doxycycline are the two drugs recommended for prophylaxis of malaria for visitors to areas where Plasmodium falciparum is resistant to chloroquine.

Objective: To compare the efficacy and tolerability of mefloquine with those of doxycycline as prophylaxis for malaria.

Design: Randomized, double-blind, placebo-controlled field trial of chemoprophylaxis of malaria.

Setting: Northeastern Irian Jaya, Indonesia.

Participants: 204 Indonesian soldiers.

Intervention: After radical curative treatment, participants were randomly assigned to receive 100 mg of doxycycline per day and mefloquine placebo; 250 mg of mefloquine per week (preceded by a loading dose of 250 mg/d for 3 days) and doxycycline placebo; or placebos for both drugs. Prophylaxis lasted approximately 13 weeks.

Measurements: The primary end point for efficacy was the first occurrence of malaria, as documented by a positive malaria smear. Malaria smears were obtained weekly and when patients had symptoms suggesting malaria. Reported symptoms were recorded daily, and an exit study questionnaire was conducted.

Results: In the placebo group, 53 of 69 soldiers developed malaria (9.1 person-years), resulting in an attack rate of 5.8 cases per person-year (95% CI, 4.3 to 7.7 cases per person-year). Plasmodium falciparum accounted for 57% of cases, and P. vivax accounted for 43% of cases. No malaria occurred in the 68 soldiers (16.9 person-years) in the mefloquine group; thus, the protective efficacy of mefloquine was 100% (CI, 96% to 100%). In the doxycycline group, P. falciparum malaria occurred in 1 of 67 soldiers (16.0 person-years), yielding a protective efficacy of 99% (CI, 94% to 100%). Both drugs were very well tolerated.

Conclusions: Mefloquine and doxycycline were both highly efficacious and well tolerated as prophylaxis of malaria in Indonesian soldiers.

Publication types

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

MeSH terms

  • Adult
  • Antimalarials / administration & dosage
  • Antimalarials / adverse effects
  • Antimalarials / therapeutic use*
  • Double-Blind Method
  • Doxycycline / administration & dosage
  • Doxycycline / adverse effects
  • Doxycycline / therapeutic use*
  • Drug Packaging
  • Follow-Up Studies
  • Humans
  • Indonesia
  • Malaria / prevention & control*
  • Male
  • Mefloquine / administration & dosage
  • Mefloquine / adverse effects
  • Mefloquine / therapeutic use*
  • Patient Compliance
  • Placebos

Substances

  • Antimalarials
  • Placebos
  • Doxycycline
  • Mefloquine