Document Detail

Evaluation of new anti-infective drugs for the treatment and prevention of infections caused by the Mycobacterium avium complex. Infectious Diseases Society of America and the Food and Drug Administration.
MedLine Citation:
PMID:  1477245     Owner:  NLM     Status:  MEDLINE    
The bacteria of the Mycobacterium avium complex are ubiquitous; thus it is often difficult to distinguish environmental contamination from colonization or infection. Patients with either pulmonary or disseminated infection may be enrolled in clinical trials. Disseminated disease occurs mostly in patients infected with the human immunodeficiency virus. In general, a randomized, active-control, double-blinded clinical trial is preferred; there should at least be a blinded evaluator. With regard to immunosuppressed populations, new antimycobacterial drugs need to be evaluated not only for the treatment but also for the prevention of disease. For trials of prophylaxis a placebo-controlled design is ethical until a drug is proven effective; then the use of an active-control regimen is appropriate. Since no regimen has been approved by the U.S. Food and Drug Administration for treatment or prevention of disease caused by the M. avium complex, demonstration of the superiority of the study regimen to the control regimen should be the objective of the clinical trial.
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:  S296-306     Citation Subset:  IM; X    
Chest Service, San Francisco General Hospital, California 94110.
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MeSH Terms
Anti-Bacterial Agents
Anti-Infective Agents / therapeutic use*
Clinical Protocols
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
Mycobacterium avium Complex / isolation & purification
Mycobacterium avium-intracellulare Infection / drug therapy*,  prevention & control
Research Design
Grant Support
HHS 223-88-1301/HS/AHRQ HHS
Reg. No./Substance:
0/Anti-Bacterial Agents; 0/Anti-Infective Agents

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

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