Critically Ill PatientsNCT04252027
Therapeutic Drug Monitoring of Fluconazole in Critically Ill Patients
An observational study of Critically Ill Patients, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
This prospective study will research the exposure and its variability to fluconazole after longitudinal administration in critically ill patients Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critically Ill Patients
- What is being tested?
- Sample collection
- How many people
- 43 participants
- Where
- 1 siteBelgium
- Study dates
- 23 Apr 2019to 5 Mar 2020
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Critically ill patients.
Who may be able to join
- > 18 years
- Treatment with fluconazole
- Admitted to an ICU ward
Who cannot join
- < 18 years
- DNR 2 or 3
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Therapeutic Drug Monitoring of Fluconazole in Critically Ill Patients: a Longitudinal Follow-up of Trough Levels
This prospective study will research the exposure and its variability to fluconazole after longitudinal administration in critically ill patients
Read the detailed description
An open label, monocenter pharmacokinetic study will be carried out in critically ill patients, admitted at the University Hospitals Leuven, receiving multiple dose treatment with fluconazole.
The exposure to fluconazole in the ICU cohort over multiple days of treatment will be documented. Moreover, variability and the correlating covariates that can influence the fluconazole concentration, will be determined.
- Conditions
- Critically Ill Patients
- Being tested
- Sample collection
- Keywords
- Pharmacokinetics, Fluconazole, Variability, Target attainment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sample collectionOther
Plasma and urine sample collection
What is being measured
The primary outcome is the main question the study is designed to answer.
Exposure to fluconazole (trough levels)
To document the trough levels (Cmin) of fluconazole in an ICU cohort over multiple days of treatment
Measured: On the day of sampling
Exposure to fluconazole (trough levels)
Determine if the Cmin target levels are attained.
Measured: June 2020
Secondary outcomes (2)
Variability in fluconazole trough levels
To determine the intra-and intersubject variability of the fluconazole trough levels
Measured: June 2020
Influencing covariates
Determine possible covariates that might explain the fluconazole variability
Measured: June 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start23 Apr 2019
- Primary completion5 Mar 2020
- Study completion5 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critically Ill PatientsStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- KU Leuven
- Responsible party
- Sponsor
- Investigators
- Isabel Spriet, PharmD, PhD, Principal investigator, UZ Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04252027
- Sponsor's protocol ID
- S62242
- Status last verified
- Apr 2021
- First submitted
- 28 Jan 2020
- Last updated
- 28 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Drug Monitoring of Fluconazole in Critically Ill Patients: a Longitudinal Follow-up of Trough Levels
- ClinicalTrials.gov ID
- NCT04252027
- Acronym / sponsor ID
- S62242
- Conditions
- Critically Ill Patients
- Keywords
- Pharmacokinetics, Fluconazole, Variability, Target attainment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Collaborators
- KU Leuven
- Study start
- 23 Apr 2019 (actual)
- Primary completion
- 5 Mar 2020 (actual)
- Study completion
- 5 Mar 2020 (actual)
- First posted
- 5 Feb 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.
This prospective study will research the exposure and its variability to fluconazole after longitudinal administration in critically ill patients
Detailed description
An open label, monocenter pharmacokinetic study will be carried out in critically ill patients, admitted at the University Hospitals Leuven, receiving multiple dose treatment with fluconazole.
The exposure to fluconazole in the ICU cohort over multiple days of treatment will be documented. Moreover, variability and the correlating covariates that can influence the fluconazole concentration, will be determined.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Critically ill patients.
Key inclusion criteria (3 listed)
- > 18 years
- Treatment with fluconazole
- Admitted to an ICU ward
Key exclusion criteria (2 listed)
- < 18 years
- DNR 2 or 3
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 |
|---|---|---|
| Sample collectionPlasma and urine sample collection | Other | – |
Primary outcome
Exposure to fluconazole (trough levels)
Time frame: On the day of sampling
To document the trough levels (Cmin) of fluconazole in an ICU cohort over multiple days of treatment
Exposure to fluconazole (trough levels)
Time frame: June 2020
Determine if the Cmin target levels are attained.
2 secondary outcomes
Variability in fluconazole trough levels
Time frame: June 2020
Influencing covariates
Time frame: June 2020
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 28 Apr 2021.
- Individual participant dataSharing planned: Undecided
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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.
Isabel Spriet, PharmD, PhD principal investigator
UZ Leuven
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 Critically Ill Patients, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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 3 inclusion and 2 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 28 Apr 2021. 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 Belgium. 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?
Exposure to fluconazole (trough levels) (time frame: On the day of sampling). The study lists 2 primary outcomes in all. 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 28 Apr 2021.