Loading clinical trials...
Loading clinical trials...
Impact of the Use of Biomarkers on Early Discontinuation of Empirical Antifungal Therapy in Critically Ill Patients: a Randomized Controlled Study.
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.
Patients requiring EAT will be randomly assigned to: * intervention group: a strategy in which EAT duration is determined by (1,3)-B-Dglucan and mannan serum assays, performed on day 0 (day of EAT initiation) and day 3. Early stop recommendation, provided before day 7, will be determined using an algorithm based on the results of biomarkers. * control group: a routine care strategy, based on international guidelines, which recommend 14 days of treatment for patients without subsequent proven ICI, and who improve under antifungal treatment, or less in other situations.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
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
Start Date
June 6, 2018
Primary Completion Date
June 1, 2024
Completion Date
June 1, 2025
Last Updated
May 16, 2024
194
ESTIMATED participants
Biomarker strategy
OTHER
Routine strategy
OTHER
Lead Sponsor
University Hospital, Lille
NCT02801682
NCT01666769
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT00250432