Pharmacokinetics of Fluconazole IV as Prophylaxis or Therapy to ICU Patients
PACIFIC
1 other identifier
observational
20
1 country
3
Brief Summary
The pharmacokinetics of fluconazole are expected to be different in ICU patients compared to non-ICU patients. The investigators will determine fluconazole and free fluconazole concentrations in 20 ICU patients, who will get intravenous fluconazole as standard care. Switching to oral/enteral fluconazol is allowed after day 3. A full pharmacokinetic curve will be taken on day 3 of iv therapy and limited pharmacokinetic curves on day 7 of iv therapy and/or on day 3 of oral therapy; trough levels will be taken daily after intravenous therapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started May 2015
Shorter than P25 for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2015
CompletedFirst Submitted
Initial submission to the registry
August 12, 2015
CompletedFirst Posted
Study publicly available on registry
January 28, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2016
CompletedDecember 7, 2020
December 1, 2020
10 months
August 12, 2015
December 4, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Area under the curve
Full pharmacokinetic curves will be taken op Day 3 and Day 7 (fluconazole).
Days 3 and 7
Secondary Outcomes (1)
body weight
Days 3 and 7
Interventions
Dose according to summary of product characteristics (SPC) or local protocols
Eligibility Criteria
All patients receiving fluconazole as prophylaxis or therapy for an (invasive) fungal infection at the ICU will be included.
You may qualify if:
- Patient is admitted to an ICU
- Subject is at least 18 years of age on the day of the first dosing
- Subject is managed with a central venous or arterial catheter
You may not qualify if:
- Is known to be hypersensitive to azole antifungal agents
- Documented history of sensitivity to medicinal products or excipients similar to those found in the fluconazole preparation
- Has previously participated in this trial
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Canisius Wilhelmina Ziekenhuis
Nijmegen, Netherlands
Radboud university medical center
Nijmegen, Netherlands
University Medical Center Utrecht
Utrecht, Netherlands
Related Publications (1)
Muilwijk EW, de Lange DW, Schouten JA, Wasmann RE, Ter Heine R, Burger DM, Colbers A, Haas PJ, Verweij PE, Pickkers P, Bruggemann RJ. Suboptimal Dosing of Fluconazole in Critically Ill Patients: Time To Rethink Dosing. Antimicrob Agents Chemother. 2020 Sep 21;64(10):e00984-20. doi: 10.1128/AAC.00984-20. Print 2020 Sep 21.
PMID: 32816723RESULT
Biospecimen
Plasma samples for determination of fluconazole and free fluconazole
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Roger Brüggemann, PharmD, PhD
Radboud University Medical Center
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 12, 2015
First Posted
January 28, 2016
Study Start
May 1, 2015
Primary Completion
March 1, 2016
Study Completion
March 1, 2016
Last Updated
December 7, 2020
Record last verified: 2020-12