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NCT05275179 Clinical Trial

Pharmacokinetic of Posaconazole in Critically Ill Patients

Critical Illness Clinical Trial

Official title:
Pharmacokinetic of Intravenous Posaconazole in Critically Ill Patients

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05275179
Other study ID # PV7263
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 11, 2021
Est. completion date November 1, 2022

Study information
Verified date November 2022
Source Universitätsklinikum Hamburg-Eppendorf
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 10
Est. completion date November 1, 2022
Est. primary completion date March 30, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - treatment with intravenous posaconazole - critically ill patient - written declaration of consent Exclusion Criteria: - no declaration of consent

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Posaconazole Therapeutic Drug Monitoring
Therapeutic Drug Monitoring is performed by measuring posaconazole concentrations in serum on seven consecutive days (anticipated).

Locations
Country Name City State
Germany University Medical Center Hamburg-Eppendorf Hamburg

Sponsors (1)
Lead Sponsor Collaborator
Universitätsklinikum Hamburg-Eppendorf

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Posaconazole Drug Exposure Measurement of posaconazole concentration in serum seven days from therapystart
Secondary population-pharmacokinetic analysis 1 Analysis of Peak Plasma Concentration (Cmax) for posaconazole in the given cohort. 12 months after close out
Secondary population-pharmacokinetic analysis 2 Analysis of Area under the plasma concentration versus time curve (AUC) for posaconazole in the given cohort. 12 months after close out
Secondary Evaluation of probability of target attainment of posaconazole Analysis of Monte-Carlo-Simulations in order to asses novel dosing regimens for posaconazole. 12 months after close out
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