Document Detail

Evaluation of new anti-infective drugs for the treatment and prevention of tuberculosis. Infectious Diseases Society of America and the Food and Drug Administration.
MedLine Citation:
PMID:  1477244     Owner:  NLM     Status:  MEDLINE    
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.
P Hopewell; M Cynamon; J Starke; M Iseman; R O'Brien
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Publication Detail:
Type:  Guideline; Journal Article; Practice Guideline; Research Support, U.S. Gov't, P.H.S.    
Journal Detail:
Title:  Clinical infectious diseases : an official publication of the Infectious Diseases Society of America     Volume:  15 Suppl 1     ISSN:  1058-4838     ISO Abbreviation:  Clin. Infect. Dis.     Publication Date:  1992 Nov 
Date Detail:
Created Date:  1993-02-05     Completed Date:  1993-02-05     Revised Date:  2007-11-15    
Medline Journal Info:
Nlm Unique ID:  9203213     Medline TA:  Clin Infect Dis     Country:  UNITED STATES    
Other Details:
Languages:  eng     Pagination:  S282-95     Citation Subset:  IM    
Chest Service, San Francisco General Hospital, California 94110.
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MeSH Terms
Antitubercular 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
Research Design
Tuberculosis / drug therapy*
Grant Support
HHS 223-88-1301/HS/AHRQ HHS
Reg. No./Substance:
0/Antitubercular Agents

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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