Knitsch, Wolfgang, Vincent, Jean-Louis ORCID: 0000-0001-6011-6951, Utzolino, Stefan, Francois, Bruno ORCID: 0000-0002-2531-1652, Dinya, Tamas, Dimopoulos, George ORCID: 0000-0002-3784-3103, Oezguenes, Ilhan, Carlos Valia, Juan, Eggimann, Philippe, Leon, Cristobal, Montravers, Philippe, Phillips, Stephen, Tweddle, Lorraine, Karas, Andreas, Brown, Malcolm and Cornely, Oliver A. (2015). A Randomized, Placebo-controlled Trial of Preemptive Antifungal Therapy for the Prevention of Invasive Candidiasis Following Gastrointestinal Surgery for Intra-abdominal Infections. Clin. Infect. Dis., 61 (11). S. 1671 - 1679. CARY: OXFORD UNIV PRESS INC. ISSN 1537-6591

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Abstract

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)-beta-D-glucan (beta DG) 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 beta DG to identify patients at high risk of IC.

Item Type: Journal Article
Creators:
CreatorsEmailORCIDORCID Put Code
Knitsch, WolfgangUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Vincent, Jean-LouisUNSPECIFIEDorcid.org/0000-0001-6011-6951UNSPECIFIED
Utzolino, StefanUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Francois, BrunoUNSPECIFIEDorcid.org/0000-0002-2531-1652UNSPECIFIED
Dinya, TamasUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Dimopoulos, GeorgeUNSPECIFIEDorcid.org/0000-0002-3784-3103UNSPECIFIED
Oezguenes, IlhanUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Carlos Valia, JuanUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Eggimann, PhilippeUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Leon, CristobalUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Montravers, PhilippeUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Phillips, StephenUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Tweddle, LorraineUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Karas, AndreasUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Brown, MalcolmUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Cornely, Oliver A.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
URN: urn:nbn:de:hbz:38-385795
DOI: 10.1093/cid/civ707
Journal or Publication Title: Clin. Infect. Dis.
Volume: 61
Number: 11
Page Range: S. 1671 - 1679
Date: 2015
Publisher: OXFORD UNIV PRESS INC
Place of Publication: CARY
ISSN: 1537-6591
Language: English
Faculty: Unspecified
Divisions: Unspecified
Subjects: no entry
Uncontrolled Keywords:
KeywordsLanguage
CRITICALLY-ILL PATIENTS; INTENSIVE-CARE-UNIT; SURGICAL-PATIENTS; DOUBLE-BLIND; HIGH-RISK; FLUCONAZOLE PROPHYLAXIS; CANDIDAL INFECTIONS; SPECIES INFECTIONS; COLONIZATION; DIAGNOSISMultiple languages
Immunology; Infectious Diseases; MicrobiologyMultiple languages
URI: http://kups.ub.uni-koeln.de/id/eprint/38579

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