Using biomarkers to guide antifungal therapy in critically ill patients
Impact of the Use of Biomarkers on Early Discontinuation of Empirical Antifungal Therapy in Critically Ill Patients: a Randomized Controlled Study.
NA · University Hospital, Lille · NCT03538912
This study is testing if using blood tests to check for fungal infections can help critically ill patients get the right amount of antifungal treatment without taking too much.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 194 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Lille (other) |
| Locations | 10 sites (Arras and 9 other locations) |
| Trial ID | NCT03538912 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of using fungal biomarkers to determine the duration of empirical antifungal therapy (EAT) in critically ill patients suspected of invasive candidiasis. Patients will be randomly assigned to either a biomarker-guided strategy, which allows for early discontinuation of EAT based on serum assays, or a standard care approach that follows international guidelines. The goal is to reduce unnecessary antifungal use without negatively impacting patient mortality rates. The study aims to provide evidence on whether biomarker utilization can improve treatment outcomes in the ICU setting.
Who should consider this trial
Good fit: Ideal candidates are critically ill patients over 18 years old who require empirical antifungal therapy for the first time in the ICU.
Not a fit: Patients with neutropenia, active malignant hemopathy, or those who have had recent bone marrow transplants may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to reduced antifungal overuse and improved patient management in critically ill patients.
How similar studies have performed: Other studies have shown promise in using biomarkers for guiding antifungal therapy, but this specific approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Arras and 9 other locations
- CH ARRAS — Arras, France (RECRUITING)
- CH de DOUAI — Douai, France (RECRUITING)
- CH Dunkerque — Dunkirk, France (RECRUITING)
- Centre Hospitalier Dr Schaffner — Lens, France (RECRUITING)
- Ch Dr.Schaffner de Lens — Lens, France (RECRUITING)
- Hôpital Roger Salengro, CHU — Lille, France (RECRUITING)
- CH Roubaix — Roubaix, France (RECRUITING)
- CHU de Rouen — Rouen, France (RECRUITING)
- Ch Tourcoing — Tourcoing, France (RECRUITING)
- Centre hospitalier de valenciennes — Valenciennes, France (RECRUITING)
Study contacts
- Principal investigator: Anahita Rouze, MD — University Hospital, Lille
- Study coordinator: Anahita Rouze, MD
- Email: anahita.rouze@chru-lille.fr
- Phone: 03 20 44 40 84
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Invasive Candidiasis, empirical antifungal therapy, invasive candidiasis, biomarkers, de-escalation, ICU