CClinicalTrials.gg
CompletedNCT05275179Updated Nov 8, 2022

Pharmacokinetic of Posaconazole in Critically Ill Patients

An observational study in Therapeutic Drug Monitoring and Critical Illness, sponsored by Universitätsklinikum Hamburg-Eppendorf. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-11-08.

Sponsored by Universitätsklinikum Hamburg-Eppendorf · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
10
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Therapeutic Drug Monitoring
  • Critical Illness

Browse trials for

03

In context

Critical Illness

1,881 studies on the registry are indexed under Critical Illness; 462 are open to participants now.

This study's enrollment of 10 is below the median of 130 across 867 observational studies indexed under Critical Illness.

Browse Critical Illness studies →

Lead sponsor

Universitätsklinikum Hamburg-Eppendorf is the lead sponsor of 403 studies on the registry; 83 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Critically ill patients treated with posaconazole intravenously.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • no declaration of consent
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
10 participants (actual)
Patient registry
No

Groups and cohorts

  • Posaconazole Therapeutic Drug Monitoring

    Therapeutic Drug Monitoring of posaconzole is performed by measuring posaconazole concentrations in serum

    Other: Posaconazole Therapeutic Drug Monitoring

Interventions

  • OtherPosaconazole Therapeutic Drug Monitoring

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

06

What researchers measure

Primary outcomes

  1. Posaconazole Drug Exposure

    Measurement of posaconazole concentration in serum

    Time frame: seven days from therapystart

Secondary outcomes

  1. population-pharmacokinetic analysis 1

    Analysis of Peak Plasma Concentration (Cmax) for posaconazole in the given cohort.

    Time frame: 12 months after close out

  2. population-pharmacokinetic analysis 2

    Analysis of Area under the plasma concentration versus time curve (AUC) for posaconazole in the given cohort.

    Time frame: 12 months after close out

  3. Evaluation of probability of target attainment of posaconazole

    Analysis of Monte-Carlo-Simulations in order to asses novel dosing regimens for posaconazole.

    Time frame: 12 months after close out

07

Study locations

1 site
  • University Medical Center Hamburg-Eppendorf
    Hamburg, 20246, Germany
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 8, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05275179
Lead sponsor
Universitätsklinikum Hamburg-Eppendorf
Responsible party
Sponsor
First posted
Mar 11, 2022
Start date
Feb 11, 2021
Primary completion
Mar 30, 2022
Completion
Nov 1, 2022
Last update
Nov 8, 2022

Study contacts

Dominic Wichmann, Prof
principal investigator · Universitätsklinikum Hamburg-Eppendorf

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion