Work

Evaluation of New Anti-Infective Drugs for the Treatment and Prevention of Tuberculosis

Year: 1992

Type: article

Abstract: This guideline addresses the evaluation of new antimycobacterial drugs in the treatment and prevention (secondary prophylaxis) of infection by M. tuberculosis. Patients may be enrolled in clinical trials on the basis of clinical and/or microbiological criteria. A therapeutic regimen will likely include a combination of drugs; a randomized, active-control, comparative clinical trial is recommended. If appropriate samples can be obtained for culture during follow-up without placing the patient at unwarranted risk, the assessment of microbiological outcome is paramount. Prophylaxis will probably require a single drug, and a similar study design is preferred.

Source: Clinical Infectious Diseases

DOI: 10.1093/clind/15.supplement_1.s282

Authors: Philip Hopewell, Michael Cynamon, Jeffrey Starke, Michael Iseman, Richard O'Brien

Institutions: Centers for Disease Control and Prevention, San Francisco General Hospital, Baylor College of Medicine, National Jewish Health, Syracuse VA Medical Center

Language: English

Topic: Tuberculosis Research and Epidemiology

Subfield: Infectious Diseases

Field: Medicine

Domain: Health Sciences

SDG: Good health and well-being

Open Access status: bronze

Funders: U.S. Food and Drug Administration, Agency for Healthcare Research and Quality