- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04502771
Therapeutic Drug Monitoring of Antifungals in Intensive Care Units (Fungi-up)
August 6, 2020 updated by: Hospices Civils de Lyon
Therapeutic Drug Monitoring of Antifungals in Patients From Intensive Care Units: a Retrospective Study
Antifungals under- and over-dosing are frequently deplored in patients treated with antifungals and receiving recommended doses, mostly in critically-ill patients.
This situation is well-described for antifungals from the azoles class mostly in patients with liver dysfunction or having concomitant drugs that may interact with azoles.
This situation is less-described using echinocandins, although recent studies reported caspofungin underdosing for critically-ill patients.
Considering that antifungals under-dosing was demonstrated to be associated with an increase in mortality, it is of utmost importance to analyse the relevance of therapeutic drug monitoring (TDM) for patients admitted in intensive care units (ICU).
This will help to identify which patients are the more prone to antifungal under or over-dosing.
Indeed, antifungals under-dosing may favour the development of clinical resistance to antifungals and increase mortality, whereas over-dosing may result in adverse events that may lead to treatment discontinuation.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
200
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Lyon, France, 69004
- Hospices Civils de Lyon, Croix-Rousse Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients who received antifungals during their ICU stay and had a TDM
Description
Inclusion Criteria:
- Adult patients who received antifungals including fluconazole, voriconazole, posaconazole, or caspofungin, during their ICU stay and had a Therapeutic Drug Monitoring (TDM)
Exclusion Criteria:
- Patients without antifungal treatment
- Patients who received an antifungal combination
- Pediatric patients
- Patients who were not admitted in ICU
- Patients who did not have a TDM
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Antifungal treatment
Patients receiving antifungal treatment during their stay in Intensive Care Unit
|
Treatment by fluconazole, voriconazole,posaconazole or caspofungin during the patient stay in Intensive Care Unit
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Antifungal blood concentration of patients admitted in intensive care units
Time Frame: Day 5 after antifungal initiation
|
Day 5 after antifungal initiation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adverse event
Time Frame: Day 30 after antifungal initiation
|
Impact of antifungal blood concentration on occurrence of adverse events and mycological failure
|
Day 30 after antifungal initiation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2018
Primary Completion (Actual)
December 31, 2019
Study Completion (Actual)
December 31, 2019
Study Registration Dates
First Submitted
August 4, 2020
First Submitted That Met QC Criteria
August 4, 2020
First Posted (Actual)
August 6, 2020
Study Record Updates
Last Update Posted (Actual)
August 7, 2020
Last Update Submitted That Met QC Criteria
August 6, 2020
Last Verified
August 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents, Local
- Anti-Infective Agents
- Enzyme Inhibitors
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Cytochrome P-450 CYP3A Inhibitors
- Cytochrome P-450 Enzyme Inhibitors
- Hormone Antagonists
- Steroid Synthesis Inhibitors
- 14-alpha Demethylase Inhibitors
- Cytochrome P-450 CYP2C9 Inhibitors
- Antifungal Agents
- Clotrimazole
- Miconazole
Other Study ID Numbers
- CRC_GHN_2020_003
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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