Intensive Care Unit PatientsFungi-upNCT04502771
Therapeutic Drug Monitoring of Antifungals in Intensive Care Units
An observational study of Intensive Care Unit Patients, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Intensive Care Unit Patients
- What is being tested?
- Antifungal treatment
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2018to 31 Dec 2019
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who received antifungals during their ICU stay and had a TDM
Who may be able to join
- Adult patients who received antifungals including fluconazole, voriconazole, posaconazole, or caspofungin, during their ICU stay and had a Therapeutic Drug Monitoring (TDM)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Intensive Care Unit Patients
- Being tested
- Antifungal treatment
- Keywords
- Fluconazole, Voriconazole, Posaconazole, Caspofungin, Therapeutic drug monitoring, Blood concentration, Under-dosing, Over-dosing, Intensive Care Unit
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antifungal treatmentDrug
Treatment by fluconazole, voriconazole,posaconazole or caspofungin during the patient stay in Intensive Care Unit
| Study group | Role | What they receive |
|---|---|---|
| Antifungal treatment | Patients receiving antifungal treatment during their stay in Intensive Care Unit Receives: Drug: Antifungal treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antifungal blood concentration of patients admitted in intensive care units
Measured: Day 5 after antifungal initiation
Secondary outcomes (1)
Adverse event
Impact of antifungal blood concentration on occurrence of adverse events and mycological failure
Measured: Day 30 after antifungal initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2020
- Study start1 Jan 2018
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intensive Care Unit PatientsStudies 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
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04502771
- Sponsor's protocol ID
- CRC_GHN_2020_003
- Acronym
- Fungi-up
- Status last verified
- Aug 2020
- First submitted
- 4 Aug 2020
- Last updated
- 7 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Drug Monitoring of Antifungals in Patients From Intensive Care Units: a Retrospective Study
- ClinicalTrials.gov ID
- NCT04502771
- Acronym / sponsor ID
- Fungi-up / CRC_GHN_2020_003
- Conditions
- Intensive Care Unit Patients
- Keywords
- Fluconazole, Voriconazole, Posaconazole, Caspofungin, Therapeutic drug monitoring, Blood concentration, Under-dosing, Over-dosing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 6 Aug 2020 (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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Antifungal treatment | – | Drug: Antifungal treatmentPatients receiving antifungal treatment during their stay in Intensive Care Unit |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who received antifungals during their ICU stay and had a TDM
Key inclusion criteria (1 listed)
- Adult patients who received antifungals including fluconazole, voriconazole, posaconazole, or caspofungin, during their ICU stay and had a Therapeutic Drug Monitoring (TDM)
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| Antifungal treatmentTreatment by fluconazole, voriconazole,posaconazole or caspofungin during the patient stay in Intensive Care Unit | Drug | Antifungal treatment |
Primary outcome
Antifungal blood concentration of patients admitted in intensive care units
Time frame: Day 5 after antifungal initiation
1 secondary outcome
Adverse event
Time frame: Day 30 after antifungal initiation
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 7 Aug 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Intensive Care Unit Patients, 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 5 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 7 Aug 2020. 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?
Antifungal blood concentration of patients admitted in intensive care units (time frame: Day 5 after antifungal initiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Aug 2020.