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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03538912
Other study ID # 2017_07
Secondary ID 2017-003793-13
Status Recruiting
Phase N/A
First received
Last updated
Start date June 6, 2018
Est. completion date June 2025

Study information

Verified date May 2024
Source University Hospital, Lille
Contact Anahita Rouze, MD
Phone 03 20 44 40 84
Email anahita.rouze@chru-lille.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 194
Est. completion date June 2025
Est. primary completion date June 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patient older than 18 years - Who require EAT for the first time in the ICU (this treatment is prescribed based on the presence of risk factors and clinical suspicion of ICI) - With an expected ICU length of stay of at least 6 days after EAT initiation - Informed written consent Exclusion Criteria: - Neutropenia (neutrophil count <500 cells /µL) - Active malignant hemopathy - Bone marrow transplantation in the last 6 months - Polyvalent immunoglobulins in the past months - Documented ICI in the past 3 months - Pregnancy or breastfeeding

Study Design


Related Conditions & MeSH terms


Intervention

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

Country Name City State
France CH ARRAS Arras
France CH de DOUAI Douai
France CH Dunkerque Dunkerque
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

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary percentage of patients receiving early discontinuation of EAT, defined as a discontinuation strictly before day 7 after EAT initiation This trial is designed to demonstrate whether, in critically ill patients suspected for ICI, the biomarker strategy, as compared with a standard strategy, is at the same time:
superior in terms of antifungal use and
Non-inferior in terms of death
day 7 after EAT initiation
Secondary death from any cause This trial is designed to demonstrate whether, in critically ill patients suspected for ICI, the biomarker strategy, as compared with a standard strategy, is at the same time:
superior in terms of antifungal use and
Non-inferior in terms of death
day 28 after EAT initiation
Secondary percentage of patients who presented a proven ICI after EAT discontinuation at day 28 or ICU discharge, if it occurs before day 28
Secondary percentage of patients who received at least two periods of antifungal treatment (prescribed for separate episodes of suspected or proven ICI) at day 28 or ICU discharge, if it occurs before day 28
Secondary intensity of Candida colonization during ICU stay Five body sites (among urine, anal swabs, pharyngeal swabs, nasal swabs, axillary swabs, gastric aspirates if patients have a nasogastric tube, and tracheal aspirates if patients are intubated or have a tracheotomy) are sampled on day 0 and then once per week for the semi-quantitative determination of yeast colonisation. The number of colony-forming units is scored as follows: score 1, <10 colony-forming units; score 2, 10 to 50 colony-forming units; score 3, >50 colony-forming units; score 4, >50 colony-forming units confluent. Intensity of colonization is determined for each date of sampling, by dividing the sum score for each colonized site by the number of sites sampled giving a mean Candida load. An overall score of >4 is possible in the case of isolation of several Candida species. at day 28 or ICU discharge, if it occurs before day 28
Secondary percentage of patients colonized with a resistant strain of Candida at day 28 or ICU discharge, if it occurs before day 28
Secondary antifungal-free days at day 28 or ICU discharge, if it occurs before day 28
Secondary ventilator-free days at day 28 or ICU discharge, if it occurs before day 28
Secondary ICU-free days at day 28 or ICU discharge, if it occurs before day 28
Secondary ICU mortality at day 28 or ICU discharge, if it occurs before day 28
Secondary day 90 mortality at day 90
Secondary Characterization of the fungal intestinal microbiota studied by standard mycology at baseline, at Day 7, day 14 day 21 and day 28
Secondary Characterization of the fungal intestinal microbiota studied by metagenomics at baseline, at Day 7, day 14 day 21 and day 28
Secondary Characterization of the bacterial intestinal microbiota studied by culture bacteriology at baseline, at Day 7, day 14 day 21 and day 28
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