Pharmacokinetic of Posaconazole in Critically Ill Patients

Sponsor
Universitätsklinikum Hamburg-Eppendorf (Other)
Overall Status
Recruiting
CT.gov ID
NCT05275179
Collaborator
(none)
10
1
21.6
0.5

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Other: Posaconazole Therapeutic Drug Monitoring

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 Design

Study Type:
Observational
Anticipated Enrollment :
10 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Pharmacokinetic of Intravenous Posaconazole in Critically Ill Patients
Actual Study Start Date :
Feb 11, 2021
Anticipated Primary Completion Date :
Mar 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm 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).

Outcome Measures

Primary Outcome Measures

  1. Posaconazole Drug Exposure [seven days from therapystart]

    Measurement of posaconazole concentration in serum

Secondary Outcome Measures

  1. population-pharmacokinetic analysis 1 [12 months after close out]

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

  2. 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.

  3. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • treatment with intravenous posaconazole

  • critically ill patient

  • written declaration of consent

Exclusion Criteria:
  • no declaration of consent

Contacts and Locations

Locations

Site City State Country Postal Code
1 University Medical Center Hamburg-Eppendorf Hamburg Germany 20246

Sponsors and Collaborators

  • Universitätsklinikum Hamburg-Eppendorf

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier:
NCT05275179
Other Study ID Numbers:
  • PV7263
First Posted:
Mar 11, 2022
Last Update Posted:
Mar 11, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 11, 2022