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

Détails

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Etat: Public
Version: Final published version
Licence: Non spécifiée
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ID Serval
serval:BIB_01F1CF8A0F47
Type
Article: article d'un périodique ou d'un magazine.
Sous-type
Synthèse (review): revue aussi complète que possible des connaissances sur un sujet, rédigée à partir de l'analyse exhaustive des travaux publiés.
Collection
Publications
Institution
Titre
Forum report: issues in the design of trials of drugs for the treatment of invasive aspergillosis
Périodique
Clinical Infectious Diseases : An Official Publication of the Infectious Diseases Society of America
Auteur⸱e⸱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
Statut éditorial
Publié
Date de publication
2003
Volume
36
Numéro
Suppl 3
Pages
S113-S116
Langue
anglais
Notes
Publication types: Journal Article
Publication Status: ppublish
Résumé
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.
Mots-clé
Antifungal Agents/therapeutic use, Aspergillosis/diagnosis, Aspergillosis/drug therapy
Pubmed
Web of science
Open Access
Oui
Création de la notice
13/07/2018 10:00
Dernière modification de la notice
25/09/2019 7:08
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