NCT02154178

Brief Summary

The investigators hypothesized that the use of biomarkers of invasive fungal infections would increase the percentage of early discontinuation of empirical antifungal therapy and thus reduce the duration of treatment in ICU patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 24, 2014

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 3, 2014

Completed
28 days until next milestone

Study Start

First participant enrolled

July 1, 2014

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

April 22, 2026

Status Verified

March 1, 2017

Enrollment Period

2.3 years

First QC Date

May 24, 2014

Last Update Submit

April 17, 2026

Conditions

Fungal InfectionCritical Illness

Keywords

empiric antifungal therapybiomarkersinvasive fungal infectionCandida

Outcome Measures

Primary Outcomes (1)

  • percentage of early discontinuation of empiric antifungal therapy

    Early discontinuation is defined as discontinuation of anti fungal treatment before the 7th day after the start of treatment

    7 days

Secondary Outcomes (5)

  • mortality in ICU

    28 days after ICU admission

  • duration of mechanical ventilation and ICU stay

    28 days after ICU admission

  • fungal colonization / infection after antifungal therapy, with or without resistant strains

    28 days after ICU admission

  • the cost of the antifungal therapy on a per duration prescribe

    28 days after ICU admission

  • the cost of hospital stays

    28 days after ICU admission

Study Arms (2)

Biomarker group

EXPERIMENTAL

Intervention group, in which the duration of empirical antifungal therapy will be based on the results of biomarkers. Biomarker group

Other: Biomarker group

Control group

NO INTERVENTION

Control group, in which the duration of empirical antifungal therapy will be based on international recommendations (14 days).

Interventions

Biomarker groupOTHER

use of invasive fungal disease biomarkers (β-1,3-glucan, mannan/anti-mannan antibodies)

Also known as: intervention group
Biomarker group

Eligibility Criteria

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

You may qualify if:

  • Age \> or = 18 years
  • Patients requiring empiric antifungal therapy the first time in the ICU
  • Predictable duration of hospitalization in the ICU ≥ 6 days

You may not qualify if:

  • Neutropenia (WBC \<1000 or neutrophils \<500/mm3)
  • Immunosuppressive therapy (chemotherapy within 3 months prior to the ICU admission, solid organ graft under immunosuppressive therapy)
  • invasive fungal infection documented in the three previous months
  • Antifungal treatment in the three previous months
  • Pregnant or lactating women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ICU, Salengro Hospital, University Hospital of Lille

Lille, Nord, 59035, France

Location

Related Publications (1)

  • Rouze A, Loridant S, Poissy J, Dervaux B, Sendid B, Cornu M, Nseir S; S-TAFE study group. Biomarker-based strategy for early discontinuation of empirical antifungal treatment in critically ill patients: a randomized controlled trial. Intensive Care Med. 2017 Nov;43(11):1668-1677. doi: 10.1007/s00134-017-4932-8. Epub 2017 Sep 22.

    PMID: 28936678RESULT

MeSH Terms

Conditions

MycosesCritical IllnessInvasive Fungal InfectionsTorulopsis

Condition Hierarchy (Ancestors)

Bacterial Infections and MycosesInfectionsDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Saad Nseir, MD, PhD

    Univ Hosp of Lille, France

    PRINCIPAL INVESTIGATOR

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

May 24, 2014

First Posted

June 3, 2014

Study Start

July 1, 2014

Primary Completion

October 1, 2016

Study Completion

December 1, 2016

Last Updated

April 22, 2026

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)