Evaluation of a Clinical Decision Support System for Fungal Infections

• Sponsor: Hospices Civils de Lyon (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT05656157
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Anticipated Duration (Months): 12
• Patients Per Site Per Month: 8.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Invasive Fungal Infections	Device: Medical device

Study Design

• Study Type: Observational
• Anticipated Enrollment: 100 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Evaluation of a Clinical Decision Support System for the Treatment of Invasive Fungal Infections
• Actual Study Start Date: Dec 1, 2022
• Anticipated Primary Completion Date: Jun 1, 2023
• Anticipated Study Completion Date: Nov 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Antifungal treatment prescribed by the clinician for an invasive fungal disease
Antifungal treatment recommended by the clinical decision support system	Device: Medical device; Clinical decision support system

Outcome Measures

Primary Outcome Measures

1. Percentage of concordance between the medical prescription and the recommendation of the clinical decision support system [January to september 2023]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospices Civils de Lyon	Lyon		France

Sponsors and Collaborators

• Hospices Civils de Lyon

Investigators

• Principal Investigator: Anne-Lise Bienvenu, PharmD, PhD, Hospices Civils de Lyon

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.

• Responsible Party: Hospices Civils de Lyon
• ClinicalTrials.gov Identifier: NCT05656157
• Other Study ID Numbers: CRC_GHN_2022_001
• First Posted: Dec 19, 2022
• Last Update Posted: Dec 21, 2022
• Last Verified: Dec 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Hospices Civils de Lyon: invasive fungal infections; antifungal treatment; clinical decision support system
• Additional relevant MeSH terms: Infections; Communicable Diseases; Mycoses; Invasive Fungal Infections

Study Results

No Results Posted as of Dec 21, 2022