A Randomized, Placebo-controlled Trial of Preemptive Antifungal Therapy for the Prevention of Invasive Candidiasis Following Gastrointestinal Surgery for Intra-abdominal Infections.

Détails

Ressource 1Télécharger: 26270686_BIB_89C88704E1A9.pdf (268.90 [Ko])
Etat: Serval
Version: Final published version
ID Serval
serval:BIB_89C88704E1A9
Type
Article: article d'un périodique ou d'un magazine.
Collection
Publications
Titre
A Randomized, Placebo-controlled Trial of Preemptive Antifungal Therapy for the Prevention of Invasive Candidiasis Following Gastrointestinal Surgery for Intra-abdominal Infections.
Périodique
Clinical Infectious Diseases
Auteur(s)
Knitsch W., Vincent J.L., Utzolino S., François B., Dinya T., Dimopoulos G., Özgüneş İ., Valía J.C., Eggimann P., León C., Montravers P., Phillips S., Tweddle L., Karas A., Brown M., Cornely O.A.
ISSN
1537-6591 (Electronic)
ISSN-L
1058-4838
Statut éditorial
Publié
Date de publication
2015
Peer-reviewed
Oui
Volume
61
Numéro
11
Pages
1671-1678
Langue
anglais
Notes
Publication types: Journal Article Publication Status: ppublish
Résumé
BACKGROUND: Patients undergoing emergency gastrointestinal surgery for intra-abdominal infection are at risk of invasive candidiasis (IC) and candidates for preemptive antifungal therapy.
METHODS: This exploratory, randomized, double-blind, placebo-controlled trial assessed a preemptive antifungal approach with micafungin (100 mg/d) in intensive care unit patients requiring surgery for intra-abdominal infection. Coprimary efficacy variables were the incidence of IC and the time from baseline to first IC in the full analysis set; an independent data review board confirmed IC. An exploratory biomarker analysis was performed using logistic regression.
RESULTS: The full analysis set comprised 124 placebo- and 117 micafungin-treated patients. The incidence of IC was 8.9% for placebo and 11.1% for micafungin (difference, 2.24%; [95% confidence interval, -5.52 to 10.20]). There was no difference between the arms in median time to IC. The estimated odds ratio showed that patients with a positive (1,3)-β-d-glucan (ßDG) result were 3.66 (95% confidence interval, 1.01-13.29) times more likely to have confirmed IC than those with a negative result.
CONCLUSIONS: This study was unable to provide evidence that preemptive administration of an echinocandin was effective in preventing IC in high-risk surgical intensive care unit patients with intra-abdominal infections. This may have been because the drug was administered too late to prevent IC coupled with an overall low number of IC events. It does provide some support for using ßDG to identify patients at high risk of IC.
CLINICAL TRIALS REGISTRATION: NCT01122368.
Pubmed
Web of science
Création de la notice
11/12/2015 12:18
Dernière modification de la notice
03/03/2018 19:08
Données d'usage