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Completed

NCT Number: NCT05275179

Pharmacokinetic of Posaconazole in Critically Ill Patients

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

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Key information

Conditions

Therapeutic Drug Monitoring Critical Illness Disease Attributes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Medical Center Hamburg-Eppendorf

Hamburg, 20246, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • no declaration of consent

Treatment and study plan

Posaconazole Therapeutic Drug Monitoring

Other

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

Primary outcomes

  1. Posaconazole Drug Exposure

    Time frame: seven days from therapystart

    Measurement of posaconazole concentration in serum

Secondary outcomes

  1. population-pharmacokinetic analysis 1

    Time frame: 12 months after close out

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

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Universitätsklinikum Hamburg-Eppendorf

Other

Registry information

Official study title

Pharmacokinetic of Intravenous Posaconazole in Critically Ill Patients

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Mar 11, 2022
Registry last updated
Nov 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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