Pharmacokinetic of Posaconazole in Critically Ill Patients

Completed

• Conditions: Critical Illness; Therapeutic Drug Monitoring
• Interventions: Other: Posaconazole Therapeutic Drug Monitoring

• Registration Number: NCT05275179
• Lead Sponsor: Universitätsklinikum Hamburg-Eppendorf

Brief Summary

The posaconazole pharmacokinetic in critically ill patients will be studied in a prospective, non-interventional, monocentric observational trial.

Detailed Description

The posaconazole pharmacokinetic in critically ill patients will be studied in a prospective, non-interventional, monocentric observational trial. Plasma specimens will be retrieved on consecutive days (max. 7 days) in order to measure posaconazole levels during the treatment episode.

Study Timeline

• Study Start: 2021-02-11
• Study First Submitted: 2022-01-21
• Study First Submitted QC: 2022-03-01
• Study First Posted: 2022-03-11
• Primary Completion: 2022-03-30
• Status Verified: 2022-11
• Study Completion: 2022-11-01
• Last Update Submitted: 2022-11-06
• Last Update Posted: 2022-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• treatment with intravenous posaconazole
• critically ill patient
• written declaration of consent

Exclusion Criteria

• no declaration of consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Posaconazole Therapeutic Drug Monitoring	Posaconazole Therapeutic Drug Monitoring	Therapeutic Drug Monitoring of posaconzole is performed by measuring posaconazole concentrations in serum

Primary Outcome Measures

Name	Time	Method
Posaconazole Drug Exposure	seven days from therapystart	Measurement of posaconazole concentration in serum

Secondary Outcome Measures

Name	Time	Method
population-pharmacokinetic analysis 1	12 months after close out	Analysis of Peak Plasma Concentration (Cmax) for posaconazole in the given cohort.
population-pharmacokinetic analysis 2	12 months after close out	Analysis of Area under the plasma concentration versus time curve (AUC) for posaconazole in the given cohort.
Evaluation of probability of target attainment of posaconazole	12 months after close out	Analysis of Monte-Carlo-Simulations in order to asses novel dosing regimens for posaconazole.

Trial Locations

Locations (1)

University Medical Center Hamburg-Eppendorf; 🇩🇪 Hamburg, Germany