Early Discontinuation of Empirical Antifungal Therapy and Biomarkers

Last updated: May 18, 2026
Sponsor: University Hospital, Lille
Overall Status: Completed

Phase

N/A

Condition

Sexually Transmitted Diseases (Stds)

Gynecological Infections

Yeast Infections

Treatment

Routine strategy

Biomarker strategy

Clinical Study ID

NCT03538912
2017_07
2017-003793-13
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patient older than 18 years

  • Who require EAT for the first time in the ICU (this treatment is prescribed based onthe 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

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

Total Participants: 192
Treatment Group(s): 2
Primary Treatment: Routine strategy
Phase:
Study Start date:
June 06, 2018
Estimated Completion Date:
September 03, 2024

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.

Connect with a study center

  • CH ARRAS

    Arras,
    France

    Site Not Available

  • CH de DOUAI

    Douai,
    France

    Site Not Available

  • CH Dunkerque

    Dunkerque,
    France

    Site Not Available

  • CH Dunkerque

    Dunkirk,
    France

    Site Not Available

  • Centre Hospitalier Dr Schaffner

    Lens,
    France

    Site Not Available

  • Ch Dr.Schaffner de Lens

    Lens,
    France

    Site Not Available

  • Hôpital Roger Salengro, CHU

    Lille,
    France

    Site Not Available

  • CH Roubaix

    Roubaix,
    France

    Site Not Available

  • CHU de Rouen

    Rouen,
    France

    Site Not Available

  • Ch Tourcoing

    Tourcoing,
    France

    Site Not Available

  • Centre hospitalier de valenciennes

    Valenciennes,
    France

    Site Not Available

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