| Evaluation of new anti-infective drugs for the treatment and prevention of tuberculosis. Infectious Diseases Society of America and the Food and Drug Administration. | |
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MedLine Citation:
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PMID: 1477244 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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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. |
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Authors:
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P Hopewell; M Cynamon; J Starke; M Iseman; R O'Brien |
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Publication Detail:
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Type: Guideline; Journal Article; Practice Guideline; Research Support, U.S. Gov't, P.H.S. |
Journal Detail:
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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:
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Created Date: 1993-02-05 Completed Date: 1993-02-05 Revised Date: 2007-11-15 |
Medline Journal Info:
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Nlm Unique ID: 9203213 Medline TA: Clin Infect Dis Country: UNITED STATES |
Other Details:
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Languages: eng Pagination: S282-95 Citation Subset: IM |
Affiliation:
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Chest Service, San Francisco General Hospital, California 94110. |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Adult Antitubercular Agents / therapeutic use* Child 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 Research Design Tuberculosis / drug therapy* |
| Grant Support | |
ID/Acronym/Agency:
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HHS 223-88-1301/HS/AHRQ HHS |
| Chemical | |
Reg. No./Substance:
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0/Antitubercular Agents |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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