Invasive Candidiasis Clinical Trial
— SEATOfficial title:
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Lille |
France,
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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