NCT03538912

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
194

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

10 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 25, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 29, 2018

Completed
8 days until next milestone

Study Start

First participant enrolled

June 6, 2018

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

May 16, 2024

Status Verified

May 1, 2024

Enrollment Period

6 years

First QC Date

April 25, 2018

Last Update Submit

May 14, 2024

Conditions

Invasive Candidiasis

Keywords

empirical antifungal therapyinvasive candidiasisbiomarkersde-escalationICU

Outcome Measures

Primary Outcomes (1)

  • 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: 1. superior in terms of antifungal use and 2. Non-inferior in terms of death

    day 7 after EAT initiation

Secondary Outcomes (13)

  • death from any cause

    day 28 after EAT initiation

  • percentage of patients who presented a proven ICI after EAT discontinuation

    at day 28 or ICU discharge, if it occurs before day 28

  • 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

  • intensity of Candida colonization during ICU stay

    at day 28 or ICU discharge, if it occurs before day 28

  • percentage of patients colonized with a resistant strain of Candida

    at day 28 or ICU discharge, if it occurs before day 28

  • +8 more secondary outcomes

Study Arms (2)

Biomarker group

OTHER

patient follow the Biomarker strategy

Other: Biomarker strategy

Routine group

OTHER

patient follow the routine strategy

Other: Routine strategy

Interventions

Biomarker strategyOTHER

EAT duration is determined by β-D-1,3-glucan and mannan serum assays, performed at day 0 (day of EAT initiation) and day 3.

Biomarker group
Routine strategyOTHER

EAT duration is based on IDSA guidelines, which recommend 14 days of treatment for patients without subsequent proven ICI, and who improve under antifungal treatment, or less in other situations.

Routine group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

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

MeSH Terms

Conditions

Candidiasis, Invasive

Condition Hierarchy (Ancestors)

CandidiasisMycosesBacterial Infections and MycosesInfectionsInvasive Fungal Infections

Study Officials

  • Anahita Rouze, MD

    University Hospital, Lille

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Anahita Rouze, MD

CONTACT

03 20 44 40 84anahita.rouze@chru-lille.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 25, 2018

First Posted

May 29, 2018

Study Start

June 6, 2018

Primary Completion

June 1, 2024

Study Completion

June 1, 2025

Last Updated

May 16, 2024

Record last verified: 2024-05

Locations

FR(10)