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.
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.
Hopewell
P
P
Chest Service, San Francisco General Hospital, California 94110.
Cynamon
M
M
Starke
J
J
Iseman
M
M
O'Brien
R
R
D000890:Anti-Infective Agents / Q000627:therapeutic use*; D002985:Clinical Protocols / Q000592:standards; D002986:Clinical Trials as Topic / Q000592:standards*; D017321:Clinical Trials, Phase I as Topic / Q000592:standards; D017322:Clinical Trials, Phase II as Topic / Q000592:standards; D017326:Clinical Trials, Phase III as Topic / Q000592:standards; D006801:Humans; D009165:Mycobacterium Infections, Nontuberculous / Q000188:drug therapy*; D012107:Research Design
D000890:Anti-Infective Agents