Pharmacokinetic of Posaconazole in Critically Ill Patients

November 6, 2022 updated by: Universitätsklinikum Hamburg-Eppendorf

Pharmacokinetic of Intravenous Posaconazole in Critically Ill Patients

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

10

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Hamburg, Germany, 20246
        • University Medical Center Hamburg-Eppendorf

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Critically ill patients treated with posaconazole intravenously.

Description

Inclusion Criteria:

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

Exclusion Criteria:

- no declaration of consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Posaconazole Therapeutic Drug Monitoring
Therapeutic Drug Monitoring of posaconzole is performed by measuring posaconazole concentrations in serum
Other: Posaconazole Therapeutic Drug Monitoring
Therapeutic Drug Monitoring is performed by measuring posaconazole concentrations in serum on seven consecutive days (anticipated).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Posaconazole Drug Exposure
Time Frame: seven days from therapystart
Measurement of posaconazole concentration in serum
seven days from therapystart

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitätsklinikum Hamburg-Eppendorf

Investigators

  • Principal Investigator: Dominic Wichmann, Prof, Universitätsklinikum Hamburg-Eppendorf

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 11, 2021

Primary Completion (Actual)

March 30, 2022

Study Completion (Actual)

November 1, 2022

Study Registration Dates

First Submitted

January 21, 2022

First Submitted That Met QC Criteria

March 1, 2022

First Posted (Actual)

March 11, 2022

Study Record Updates

Last Update Posted (Actual)

November 8, 2022

Last Update Submitted That Met QC Criteria

November 6, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PV7263

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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