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RECRUITING
NCT03538912
NA

Early Discontinuation of Empirical Antifungal Therapy and Biomarkers

Sponsor: University Hospital, Lille

View on ClinicalTrials.gov

Summary

Empirical antifungal therapy (EAT) is frequently prescribed to septic critically ill patients with risk factors for invasive Candida infections (ICI). However, among patients without subsequent proven ICI, antifungal discontinuation is rarely performed, resulting in unnecessary antifungal overuse. The investigators postulate that the use of fungal biomarkers could increase the percentage of early discontinuation of EAT among critically ill patients suspected of ICI, as compared with a standard strategy, without negative impact on day 28-mortality. To test this hypothesis, the investigators designed a randomized controlled open-label parallel-group study.

Official title: Impact of the Use of Biomarkers on Early Discontinuation of Empirical Antifungal Therapy in Critically Ill Patients: a Randomized Controlled Study.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

194

Start Date

2018-06-06

Completion Date

2025-06

Last Updated

2024-05-16

Healthy Volunteers

No

Interventions

OTHER

Biomarker strategy

EAT duration is determined by β-D-1,3-glucan and mannan serum assays, performed at day 0 (day of EAT initiation) and day 3.

OTHER

Routine strategy

EAT duration is based on IDSA guidelines, which recommend 14 days of treatment for patients without subsequent proven ICI, and who improve under antifungal treatment, or less in other situations.

Locations (10)

CH ARRAS

Arras, France

CH de DOUAI

Douai, France

CH Dunkerque

Dunkirk, France

Centre Hospitalier Dr Schaffner

Lens, France

Ch Dr.Schaffner de Lens

Lens, France

Hôpital Roger Salengro, CHU

Lille, France

CH Roubaix

Roubaix, France

CHU de Rouen

Rouen, France

Ch Tourcoing

Tourcoing, France

Centre hospitalier de valenciennes

Valenciennes, France