Invasive Fungal InfectionsNCT05656157
Evaluation of a Clinical Decision Support System for Fungal Infections
An observational study of Invasive Fungal Infections, run by Hospices Civils de Lyon at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Invasive Fungal Infections
- What is being tested?
- Medical device
- Type of treatment
- Medical device
- How many people
- 278 participants
- Where
- 1 siteFrance
- Study dates
- 1 Dec 2022to 30 Nov 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients receiving antifungal therapy for the treatment of invasive fungal disease
Who may be able to join
- Patients receiving antifungal therapy for the treatment of invasive fungal disease
Who cannot join
- Patients not receiving antifungal therapy for the treatment of invasive fungal disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of a Clinical Decision Support System for the Treatment of Invasive Fungal Infections
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.
- Conditions
- Invasive Fungal Infections
- Being tested
- Medical device
- Keywords
- invasive fungal infections, antifungal treatment, clinical decision support system
- Medical subject headings
- Invasive Fungal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical deviceDevice
Clinical decision support system
| Study group | Role | What they receive |
|---|---|---|
| Antifungal treatment prescribed by the clinician for an invasive fungal disease | Not described | |
| Antifungal treatment recommended by the clinical decision support system | Not described Receives: Device: Medical device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of concordance between the medical prescription and the recommendation of the clinical decision support system
Measured: January to september 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2022
- Study start1 Dec 2022
- Primary completion1 Jun 2023
- Study completion30 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Invasive Fungal InfectionsStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 278 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anne-Lise Bienvenu, PharmD, PhD, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05656157
- Sponsor's protocol ID
- CRC_GHN_2022_001
- Status last verified
- Apr 2024
- First submitted
- 9 Dec 2022
- Last updated
- 15 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 31982622Bienvenu 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.
PubMed 35771615Bienvenu 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.
PubMed 38656566
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Clinical Decision Support System for the Treatment of Invasive Fungal Infections
- ClinicalTrials.gov ID
- NCT05656157
- Acronym / sponsor ID
- CRC_GHN_2022_001
- Conditions
- Invasive Fungal Infections
- Keywords
- invasive fungal infections, antifungal treatment, clinical decision support system
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 278 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 19 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Antifungal treatment prescribed by the clinician for an invasive fungal disease | – | – |
| Antifungal treatment recommended by the clinical decision support system | – | Device: Medical device |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients receiving antifungal therapy for the treatment of invasive fungal disease
Key inclusion criteria (1 listed)
- Patients receiving antifungal therapy for the treatment of invasive fungal disease
Key exclusion criteria (1 listed)
- Patients not receiving antifungal therapy for the treatment of invasive fungal disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medical deviceClinical decision support system | Device | Antifungal treatment recommended by the clinical decision support system |
Primary outcome
Percentage of concordance between the medical prescription and the recommendation of the clinical decision support system
Time frame: January to september 2023
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2024.
- Background: PubMed 31982622Bienvenu 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.
- Results publication: PubMed 35771615Bienvenu 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.
- Derived from this study: PubMed 38656566Bienvenu 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne-Lise Bienvenu, PharmD, PhD principal investigator
Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Invasive Fungal Infections, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of concordance between the medical prescription and the recommendation of the clinical decision support system (time frame: January to september 2023). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05656157, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2024.