Document Detail

Forum report: issues in the design of trials of drugs for the treatment of invasive aspergillosis.
MedLine Citation:
PMID:  12679894     Owner:  NLM     Status:  MEDLINE    
A recent trial of drugs for invasive aspergillosis was used as a background for discussing critical features in the design of antifungal trials. The study under discussion allowed stopping either drug without classifying the patient as having treatment failure, so the trial should be understood as a comparison of 2 treatment strategies, not just 2 drugs. Although the study was a noninferiority trial, the outcome permitted a claim of superiority. Use of the category of "probable" in addition to "proven" aspergillosis permitted inclusion of patients for whom the diagnosis was less certain but who were still early enough in the disease progression to respond to therapy. Different opinions still exist about some of the criteria for the diagnosis of "probable" aspergillosis. A blinded data review committee was helpful in evaluating efficacy in this unblinded trial but had limited value in assessing toxicity. An understanding of these features of design of antifungal drug trials is important in applying the results to clinical practice.
John E Bennett; John Powers; Ben de Pauw; William Dismukes; John Galgiani; Michel Glauser; Raoul Herbrecht; Carol Kauffman; Jeannette Lee; Peter Pappas; John Rex; Paul Verweij; Claudio Viscoli; Thomas Walsh
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Clinical infectious diseases : an official publication of the Infectious Diseases Society of America     Volume:  36     ISSN:  1537-6591     ISO Abbreviation:  Clin. Infect. Dis.     Publication Date:  2003 Apr 
Date Detail:
Created Date:  2003-04-07     Completed Date:  2003-04-22     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:  S113-6     Citation Subset:  IM    
Clinical Mycology Section, Laboratory of Clinical Investigation, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland 20892, USA.
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MeSH Terms
Antifungal Agents / therapeutic use*
Aspergillosis / diagnosis,  drug therapy*
Biomedical Research
Clinical Trials as Topic*
Patient Selection
Research Design*
Reg. No./Substance:
0/Antifungal Agents

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

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