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Search / Trial NCT03538912

Early Discontinuation of Empirical Antifungal Therapy and Biomarkers

Launched by UNIVERSITY HOSPITAL, LILLE · May 24, 2018

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Empirical Antifungal Therapy Invasive Candidiasis Biomarkers De Escalation Icu

ClinConnect Summary

This clinical trial is studying whether using special tests called fungal biomarkers can help doctors decide when to stop giving antifungal medications to critically ill patients who are suspected of having a serious fungal infection called invasive candidiasis. Currently, many patients receive these medications, but they may not actually need them, leading to unnecessary treatment. The goal is to see if using these biomarkers allows for safely stopping antifungal therapy earlier, without affecting the patients' chances of survival after 28 days.

To participate in this trial, patients must be over 18 years old, be starting antifungal treatment for the first time in the ICU, and be expected to stay in the ICU for at least six days after starting the treatment. Patients who have certain health conditions, such as very low white blood cell counts or recent cancer treatments, will not be eligible to participate. If enrolled, participants can expect to be randomly assigned to either the group that uses biomarkers to guide treatment decisions or a standard treatment group. This study aims to improve patient care while ensuring safety and effectiveness in treating potential infections.

Gender

ALL

Eligibility 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

About University Hospital, Lille

University Hospital Lille is a leading academic medical institution dedicated to advancing healthcare through innovative clinical research and patient-centered care. As a prominent sponsor of clinical trials, the hospital leverages its extensive resources, multidisciplinary expertise, and state-of-the-art facilities to facilitate groundbreaking studies across various medical fields. Committed to enhancing therapeutic options and improving patient outcomes, University Hospital Lille collaborates with researchers, healthcare professionals, and industry partners to ensure rigorous scientific standards and ethical practices in all clinical trials.

Locations

Rouen, , France

Valenciennes, , France

Dunkerque, , France

Arras, , France

Douai, , France

Lens, , France

Tourcoing, , France

Roubaix, , France

Lens, , France

Lille, , France

Patients applied

0 patients applied

Trial Officials

Anahita Rouze, MD

Principal Investigator

University Hospital, Lille

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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