Pharmacokinetics of Fluconazole IV as Prophylaxis or Therapy to ICU Patients

Completed

• Conditions: Candidiasis

• Registration Number: NCT02666716
• Lead Sponsor: Radboud University Medical Center

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.

Detailed Description

The pharmacokinetics of fluconazole are expected to be different in ICU patients compared to non-ICU patients and healthy volunteers due to underlying disease(s). Therefore, extrapolation of data from healthy volunteers and non-ICU patients is not possible.

To be able to include 20 patients within the study duration, a multi-centre approach is necessary.

Patients will receive standard care, as stated in the product characteristics or according to local protocols. Blood sampling for pharmacokinetic analysis will be retrieved through a central venous catheter. A maximum of 62 milliliter blood in total will be drawn for this study. Patients will be monitored daily during the treatment period for adverse events of the study drug.

Full pharmacokinetic curves will be taken on day 3 of iv therapy. Limited pharmacokinetic curves will be taken on day 7 of iv therapy. These two moments of pharmacokinetic analysis will enable the determination steady state and enable the determination of intra-individual variability.

As probably not all patients included will be treated with iv fluconazole for 7 days, switching to oral/enteral therapy is allowed after day 3. To assess bioavailability limited pharmacokinetic curves will be taken on day 3 of oral/enteral therapy.

Study Timeline

• Study Start: 2015-05
• Study First Submitted: 2015-08-12
• Study First Submitted QC: 2016-01-25
• Study First Posted: 2016-01-28
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-04
• Last Update Posted: 2020-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. Patient is admitted to an ICU
2. Subject is at least 18 years of age on the day of the first dosing
3. Subject is managed with a central venous or arterial catheter

Exclusion Criteria

1. Is known to be hypersensitive to azole antifungal agents
2. Documented history of sensitivity to medicinal products or excipients similar to those found in the fluconazole preparation
3. Has previously participated in this trial

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Area under the curve	Days 3 and 7	Full pharmacokinetic curves will be taken op Day 3 and Day 7 (fluconazole).

Secondary Outcome Measures

Name	Time	Method
body weight	Days 3 and 7	Identifying influence of body weight on the pharmacokinetics of fluconazole.

Trial Locations

Locations (3)

Canisius Wilhelmina Ziekenhuis; 🇳🇱 Nijmegen, Netherlands

Radboud university medical center; 🇳🇱 Nijmegen, Netherlands

University Medical Center Utrecht; 🇳🇱 Utrecht, Netherlands