Forum report: issues in the design of trials of drugs for the treatment of invasive aspergillosis

Details

Ressource 1Download: 483.pdf (59.98 [Ko])
State: Public
Version: author
License: Not specified
It was possible to publish this article open access thanks to a Swiss National Licence with the publisher.
Serval ID
serval:BIB_01F1CF8A0F47
Type
Article: article from journal or magazin.
Publication sub-type
Review (review): journal as complete as possible of one specific subject, written based on exhaustive analyses from published work.
Collection
Publications
Institution
Title
Forum report: issues in the design of trials of drugs for the treatment of invasive aspergillosis
Journal
Clinical Infectious Diseases : An Official Publication of the Infectious Diseases Society of America
Author(s)
Bennett J.E., Powers J., de Pauw B., Dismukes W., Galgiani J., Glauser M., Herbrecht R., Kauffman C., Lee J., Pappas P., Rex J., Verweij P., Viscoli C., Walsh T.
ISSN
1537-6591 (Electronic)
ISSN-L
1058-4838
Publication state
Published
Issued date
2003
Volume
36
Number
Suppl 3
Pages
S113-S116
Language
english
Notes
Publication types: Journal Article
Publication Status: ppublish
Abstract
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.
Keywords
Antifungal Agents/therapeutic use, Aspergillosis/diagnosis, Aspergillosis/drug therapy
Pubmed
Web of science
Open Access
Yes
Create date
13/07/2018 10:00
Last modification date
25/09/2019 7:08
Usage data