NCT05275179

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 11, 2021

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

January 21, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 11, 2022

Completed
19 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2022

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2022

Completed
Last Updated

November 8, 2022

Status Verified

November 1, 2022

Enrollment Period

1.1 years

First QC Date

January 21, 2022

Last Update Submit

November 6, 2022

Conditions

Therapeutic Drug MonitoringCritical Illness

Outcome Measures

Primary Outcomes (1)

  • Posaconazole Drug Exposure

    Measurement of posaconazole concentration in serum

    seven days from therapystart

Secondary Outcomes (3)

  • population-pharmacokinetic analysis 1

    12 months after close out

  • population-pharmacokinetic analysis 2

    12 months after close out

  • Evaluation of probability of target attainment of posaconazole

    12 months after close out

Study Arms (1)

Posaconazole Therapeutic Drug Monitoring

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

Other: Posaconazole Therapeutic Drug Monitoring

Interventions

Posaconazole Therapeutic Drug MonitoringOTHER

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

Posaconazole Therapeutic Drug Monitoring

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Critically ill patients treated with posaconazole intravenously.

You may qualify if:

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

You may not qualify if:

  • \- no declaration of consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Center Hamburg-Eppendorf

Hamburg, 20246, Germany

Location

Related Publications (1)

  • Konig C, Gopfert M, Kluge S, Wichmann D. Posaconazole exposure in critically ill ICU patients: a need for action. Infection. 2023 Dec;51(6):1767-1772. doi: 10.1007/s15010-023-02078-9. Epub 2023 Jul 27.

    PMID: 37498488DERIVED

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Dominic Wichmann, Prof

    Universitätsklinikum Hamburg-Eppendorf

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 21, 2022

First Posted

March 11, 2022

Study Start

February 11, 2021

Primary Completion

March 30, 2022

Study Completion

November 1, 2022

Last Updated

November 8, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)