NCT05656157

Brief Summary

Invasive fungal infections are serious and frequent diseases in our hospitals, especially in intensive care units. In accordance with the institutional recommendations, it is necessary to have a clinical decision support system to support the clinicians in a rapid and optimal prescription of antifungals for invasive fungal diseases. This clinical decision support system will benefit patients but also clinicians who will gain in medical efficiency. It will also have an ethical dimension since it will guarantee optimal antifungal treatments for all patients. The purpose of the research is to define the percentage of concordance between the medical prescription and the recommendation of the clinical decision support system.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
278

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2022

Shorter than P25 for all trials

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

Study Start

First participant enrolled

December 1, 2022

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

December 9, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 19, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2023

Completed
Last Updated

April 15, 2024

Status Verified

April 1, 2024

Enrollment Period

6 months

First QC Date

December 9, 2022

Last Update Submit

April 12, 2024

Conditions

Keywords

invasive fungal infectionsantifungal treatmentclinical decision support system

Outcome Measures

Primary Outcomes (1)

  • Percentage of concordance between the medical prescription and the recommendation of the clinical decision support system

    January to september 2023

Study Arms (2)

Antifungal treatment prescribed by the clinician for an invasive fungal disease

Antifungal treatment recommended by the clinical decision support system

Device: Medical device

Interventions

Clinical decision support system

Antifungal treatment recommended by the clinical decision support system

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients receiving antifungal therapy for the treatment of invasive fungal disease

You may qualify if:

  • Patients receiving antifungal therapy for the treatment of invasive fungal disease

You may not qualify if:

  • Patients not receiving antifungal therapy for the treatment of invasive fungal disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospices Civils de Lyon

Lyon, France

Location

Related Publications (3)

  • Bienvenu AL, Pradat P, Guerin C, Aubrun F, Fellahi JL, Friggeri A, Guichon C, Hernu R, Menotti J, Monard C, Paulus S, Rimmele T, Piriou V, Chidiac C, Argaud L, Leboucher G. Evaluation of first-line therapies for the treatment of candidemia in ICU patients: A propensity score analysis. Int J Infect Dis. 2020 Apr;93:15-21. doi: 10.1016/j.ijid.2020.01.037. Epub 2020 Jan 23.

    PMID: 31982622BACKGROUND
  • Bienvenu AL, Pavese P, Leboucher G, Berger P, Roux S, Charmillon A, Foroni L, Menotti J, Lebeaux D, Mayan R, Mondain V, Robin C, Lesprit P, Alfandari S, Kerneis S. Practical checklist for implementation of antifungal stewardship programmes. J Med Microbiol. 2022 Jun;71(6). doi: 10.1099/jmm.0.001560.

  • Bienvenu AL, Cour M, Pavese P, Guichon C, Leray V, Chapuis C, Dureault A, Mohkam K, Gallet S, Bourget S, Kahale E, Chaabane W, Subtil F, Maucort-Boulch D, Talbot F, Dode X, Richard JC, Leboucher G. Correlation between antifungal clinical practices and a new clinical decision support system ANTIFON-CLIC(R) for the treatment of invasive candidiasis: a retrospective multicentre study. J Antimicrob Chemother. 2024 Jun 3;79(6):1407-1412. doi: 10.1093/jac/dkae118.

MeSH Terms

Conditions

Invasive Fungal Infections

Interventions

Equipment and Supplies

Condition Hierarchy (Ancestors)

MycosesBacterial Infections and MycosesInfections

Study Officials

  • Anne-Lise Bienvenu, PharmD, PhD

    Hospices Civils de Lyon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 9, 2022

First Posted

December 19, 2022

Study Start

December 1, 2022

Primary Completion

June 1, 2023

Study Completion

November 30, 2023

Last Updated

April 15, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations