Evaluation of new anti-infective drugs for the treatment of disease caused by Mycobacterium kansasii and other mycobacteria. Infectious Diseases Society of America and the Food and Drug Administration

Clin Infect Dis. 1992 Nov:15 Suppl 1:S307-12. doi: 10.1093/clind/15.supplement_1.s307.

Abstract

Mycobacterium kansasii is a photochromogenic nontuberculous mycobacterium that usually causes infections of the respiratory tract in humans. Although spontaneous resolution of infection has been reported, most patients require antimycobacterial therapy. A three- or four-drug combination--isoniazid, rifampin, and ethambutol and/or streptomycin--usually is prescribed. For evaluation of a new drug, a randomized, double-blind or evaluator-blinded, active-control comparative study design is recommended. Treatment should continue for 18-24 months, and follow-up evaluations should be conducted every 6 months for 3 years. Microbiological outcome is paramount.

Publication types

  • Guideline
  • Practice Guideline
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Anti-Infective Agents / therapeutic use*
  • Clinical Protocols / standards
  • Clinical Trials as Topic / standards*
  • Clinical Trials, Phase I as Topic / standards
  • Clinical Trials, Phase II as Topic / standards
  • Clinical Trials, Phase III as Topic / standards
  • Humans
  • Mycobacterium Infections, Nontuberculous / drug therapy*
  • Research Design

Substances

  • Anti-Infective Agents