Critically Ill PatientsNCT04045366
Impact of Capillary Leak and Hypoalbuminemia on PK/PD of Anidulafungin and Caspofungin 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 explore the pharmacokinetic exposure and pharmacodynamics of the echinocandins (caspofungin or anidulafungin) 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
- 60 participants
- Where
- 1 siteBelgium
- Study dates
- 21 Sep 2012to 31 Dec 2025
- 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
- Treatment with anidulafungin or caspofungin
- Admitted to an ICU ward
Who cannot join
- < 18 years
- DNR 2 or 3
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
UZ Leuven
Leuven, 3000
Isabel Spriet, PharmD, PhD, +32 16 34 30 80, isabel.spriet@uzleuven.be
Ruth Van Daele, PharmD, +32 16 34 30 80, ruth.vandaele@uzleuven.be
About this study
This prospective study will explore the pharmacokinetic exposure and pharmacodynamics of the echinocandins (caspofungin or anidulafungin) in critically ill patients.
Read the detailed description
This non-randomized, monocenter pharmacokinetic study will be carried out in critically ill patients receiving multiple dose treatment with echinocandins (caspofungin or anidulafungin).
The pharmacokinetics and pharmacodynamics of the echinocandins in plasma and BAL will be determined. Especially, the relative contributions of two pathophysiological alterations (capillary leak and hypoalbuminemia) encountered in critically ill patients, will be explored.
Also other correlating covariates will be identified to provide a rationale for optimal dosing strategy in critically ill patients.
- Conditions
- Critically Ill Patients
- Being tested
- Sample collection
- Keywords
- Pharmacokinetics, Echinocandins, Critically ill patients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sample collectionOther
Plasma and BAL sample collection
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the curve (AUC)
The area under the concentration-time curve will be calculated
Measured: July 2020
Half-life (T1/2)
The half-life will be calculated
Measured: July 2020
Volume of distribution (Vd)
The volume of distribution will be calculated
Measured: July 2020
Clearance (CL)
The clearance will be calculated
Measured: July 2020
Maximum plasma concentration
The median maximum plasma concentration will be reported
Measured: July 2020
Minimum plasma concentration
The median minimum plasma concentration will be reported
Measured: July 2020
Average plasma concentration
The average plasma concentration will be calculated
Measured: July 2020
Secondary outcomes (17)
Influence of serum creatinin (mg/dL) on echinocandin-exposure
Measured: July 2020
Influence of glomerular filtration rate (ml/min) on echinocandin-exposure
Measured: July 2020
Influence of on bilirubin on echinocandin-exposure
Measured: July 2020
Influence of gamma-GT on echinocandin-exposure
Measured: July 2020
Influence of alkaline phosphatase on echinocandin-exposure
Measured: July 2020
Influence of AST on echinocandin-exposure
Measured: July 2020
Influence of ALT on echinocandin-exposure
Measured: July 2020
Influence of SOFA ( sequential organ failure assessment) score on echinocandin-exposure
Measured: July 2020
Influence of APACHE II (Acute Physiology and Chronic Health Evaluation II) score on echinocandin-exposure
Measured: July 2020
Influence of total protein on echinocandin-exposure
Measured: July 2020
Influence of serum albumin on echinocandin-exposure
Measured: July 2020
Influence of Ang-1 on echinocandin-exposure
Measured: July 2020
Influence of Ang-2 on echinocandin-exposure
Measured: July 2020
Influence of VEGF on echinocandin-exposure
Measured: July 2020
Influence of inflammation (CRP) on echinocandin-exposure
Measured: July 2020
Influence of fluid balance (mL) on echinocandin-exposure
Measured: July 2020
Influence of prothrombin time on echinocandin-exposure
Measured: July 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2019
- Study start21 Sep 2012
- Primary completion1 Jul 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
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
- 60 participants (estimated)
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
- NCT04045366
- Sponsor's protocol ID
- S54510
- Status last verified
- Jul 2024
- First submitted
- 14 Jun 2019
- Last updated
- 3 Jul 2024
- 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 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Capillary Leak and Hypoalbuminemia on PK/PD of Anidulafungin and Caspofungin in Critically Ill Patients
- ClinicalTrials.gov ID
- NCT04045366
- Acronym / sponsor ID
- S54510
- Conditions
- Critically Ill Patients
- Keywords
- Pharmacokinetics, Echinocandins, Critically ill patients
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Collaborators
- KU Leuven
- Study start
- 21 Sep 2012 (actual)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 5 Aug 2019 (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 explore the pharmacokinetic exposure and pharmacodynamics of the echinocandins (caspofungin or anidulafungin) in critically ill patients.
Detailed description
This non-randomized, monocenter pharmacokinetic study will be carried out in critically ill patients receiving multiple dose treatment with echinocandins (caspofungin or anidulafungin).
The pharmacokinetics and pharmacodynamics of the echinocandins in plasma and BAL will be determined. Especially, the relative contributions of two pathophysiological alterations (capillary leak and hypoalbuminemia) encountered in critically ill patients, will be explored.
Also other correlating covariates will be identified to provide a rationale for optimal dosing strategy in critically ill patients.
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 (2 listed)
- Treatment with anidulafungin or caspofungin
- 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 BAL sample collection | Other | – |
Primary outcome
Area under the curve (AUC)
Time frame: July 2020
The area under the concentration-time curve will be calculated
Half-life (T1/2)
Time frame: July 2020
The half-life will be calculated
Volume of distribution (Vd)
Time frame: July 2020
The volume of distribution will be calculated
Clearance (CL)
Time frame: July 2020
The clearance will be calculated
Maximum plasma concentration
Time frame: July 2020
The median maximum plasma concentration will be reported
Minimum plasma concentration
Time frame: July 2020
The median minimum plasma concentration will be reported
Average plasma concentration
Time frame: July 2020
The average plasma concentration will be calculated
17 secondary outcomes
Influence of serum creatinin (mg/dL) on echinocandin-exposure
Time frame: July 2020
Influence of glomerular filtration rate (ml/min) on echinocandin-exposure
Time frame: July 2020
Influence of on bilirubin on echinocandin-exposure
Time frame: July 2020
Influence of gamma-GT on echinocandin-exposure
Time frame: July 2020
Influence of alkaline phosphatase on echinocandin-exposure
Time frame: July 2020
Influence of AST on echinocandin-exposure
Time frame: July 2020
Influence of ALT on echinocandin-exposure
Time frame: July 2020
Influence of SOFA ( sequential organ failure assessment) score on echinocandin-exposure
Time frame: July 2020
Influence of APACHE II (Acute Physiology and Chronic Health Evaluation II) score on echinocandin-exposure
Time frame: July 2020
Influence of total protein on echinocandin-exposure
Time frame: July 2020
Influence of serum albumin on echinocandin-exposure
Time frame: July 2020
Influence of Ang-1 on echinocandin-exposure
Time frame: July 2020
Influence of Ang-2 on echinocandin-exposure
Time frame: July 2020
Influence of VEGF on echinocandin-exposure
Time frame: July 2020
Influence of inflammation (CRP) on echinocandin-exposure
Time frame: July 2020
Influence of fluid balance (mL) on echinocandin-exposure
Time frame: July 2020
Influence of prothrombin time on echinocandin-exposure
Time frame: July 2020
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- 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 2 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: status not confirmed, as of the sponsor's last update on 3 Jul 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Isabel Spriet, PharmD, PhD (+32 16 34 30 80, isabel.spriet@uzleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the curve (AUC) (time frame: July 2020). The study lists 7 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 3 Jul 2024.