Exploring how capillary leak and low albumin affect antifungal drug levels in critically ill patients
Impact of Capillary Leak and Hypoalbuminemia on PK/PD of Anidulafungin and Caspofungin in Critically Ill Patients
This study is testing how conditions like capillary leak and low albumin affect the levels of antifungal drugs in critically ill patients to find the best dosing strategies.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Universitaire Ziekenhuizen KU Leuven Academic / other |
| Locations | 1 site (Leuven) |
| Trial ID | NCT04045366 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the pharmacokinetics and pharmacodynamics of echinocandins, specifically caspofungin and anidulafungin, in critically ill patients. It will be conducted at a single center and will involve the collection of plasma and bronchoalveolar lavage (BAL) samples to assess drug exposure and effects. The study will particularly focus on how conditions like capillary leak and hypoalbuminemia influence drug behavior in these patients, with the goal of identifying optimal dosing strategies.
Who should consider this trial
Good fit: Ideal candidates for this study are critically ill patients who are being treated with anidulafungin or caspofungin and are admitted to an ICU ward.
Not a fit: Patients under 18 years old or those with a Do Not Resuscitate (DNR) order may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved dosing strategies for antifungal treatments in critically ill patients, enhancing their therapeutic outcomes.
How similar studies have performed: While the specific approach of this study may be novel, previous studies have explored pharmacokinetics in critically ill patients, indicating potential for meaningful insights.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Treatment with anidulafungin or caspofungin * Admitted to an ICU ward Exclusion Criteria: * \< 18 years * DNR 2 or 3
Where this trial is running
Leuven
- UZ Leuven — Leuven, Belgium (Recruiting)
Study contacts
- Principal investigator: Isabel Spriet, PharmD, PhD — UZ Leuven
- Study coordinator: Isabel Spriet, PharmD, PhD
- Email: isabel.spriet@uzleuven.be
- Phone: +32 16 34 30 80
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.