Informations générales (source: ClinicalTrials.gov)
Impact of the Use of Biomarkers on Early Discontinuation of Empirical Antifungal Therapy in Critically Ill Patients: a Randomized Controlled Study. (SEAT)
Interventional
N/A
University Hospital, Lille (Voir sur ClinicalTrials)
juin 2018
juin 2025
29 juin 2024
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.
Etablissements
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| Centre Hospitalier Dr Schaffner - Lens - France | Contact (sur clinicalTrials) | ||||
| CH ARRAS - Arras - France | Contact (sur clinicalTrials) | ||||
| CH de DOUAI - Douai - France | Contact (sur clinicalTrials) | ||||
| Ch Dr.Schaffner de Lens - Lens - France | Contact (sur clinicalTrials) | ||||
| CH Dunkerque - Dunkerque - France | Contact (sur clinicalTrials) | ||||
| CH Roubaix - Roubaix - France | Contact (sur clinicalTrials) | ||||
| Ch Tourcoing - Tourcoing - France | Contact (sur clinicalTrials) | ||||
| CHU de Rouen - Rouen - France | Contact (sur clinicalTrials) | ||||
| Hôpital Roger Salengro, CHU - Lille - France | Contact (sur clinicalTrials) | ||||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre hospitalier de valenciennes - Valenciennes - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
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
- 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
- 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