A randomized evaluation of ethambutol for prevention of relapse and drug resistance during treatment of Mycobacterium avium complex bacteremia with clarithromycin-based combination therapy. California Collaborative Treatment Group

J Infect Dis. 1997 Nov;176(5):1225-32. doi: 10.1086/514116.

Abstract

Patients with AIDS and Mycobacterium avium complex (MAC) bacteremia are at high risk for relapse and emergence of resistant isolates during monotherapy with clarithromycin. Ninety-five AIDS patients with MAC bacteremia received clarithromycin plus clofazimine, with or without ethambutol, in a prospective, multicenter, randomized open-label trial. Of 80 patients with positive baseline cultures, sterilization or a 2 log10 reduction in colony-forming units of MAC in two consecutive blood cultures occurred in 69% of both groups. There were nine relapses in the two-drug arm and three in the three-drug arm. Kaplan-Meier estimates of risk of relapse at 36 weeks were 68% and 12%, respectively (P = .004). All relapse isolates were resistant to clarithromycin. Median time to clarithromycin resistance was 16 weeks with two drugs and 40 weeks with three drugs (P = .004). Ethambutol reduced relapses and emergence of clarithromycin resistance and should be considered an essential component of clarithromycin-based therapies for MAC bacteremia.

Publication types

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

MeSH terms

  • Adult
  • Anti-Bacterial Agents / administration & dosage*
  • Antitubercular Agents / administration & dosage*
  • Bacteremia / drug therapy*
  • Clarithromycin / administration & dosage*
  • Clarithromycin / adverse effects
  • Drug Resistance, Microbial
  • Drug Therapy, Combination
  • Ethambutol / administration & dosage*
  • Ethambutol / adverse effects
  • Female
  • Humans
  • Male
  • Mycobacterium avium-intracellulare Infection / drug therapy*
  • Prospective Studies
  • Recurrence

Substances

  • Anti-Bacterial Agents
  • Antitubercular Agents
  • Ethambutol
  • Clarithromycin