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The posaconazole pharmacokinetic in critically ill patients will be studied in a prospective, non-interventional, monocentric observational trial.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Posaconazole Therapeutic Drug Monitoring | Therapeutic Drug Monitoring of posaconzole is performed by measuring posaconazole concentrations in serum |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Posaconazole Therapeutic Drug Monitoring | Other | Therapeutic Drug Monitoring is performed by measuring posaconazole concentrations in serum on seven consecutive days (anticipated). |
| Measure | Description | Time Frame |
|---|---|---|
| Posaconazole Drug Exposure | Measurement of posaconazole concentration in serum | seven days from therapystart |
| Measure | Description | Time Frame |
|---|---|---|
| population-pharmacokinetic analysis 1 | Analysis of Peak Plasma Concentration (Cmax) for posaconazole in the given cohort. | 12 months after close out |
| population-pharmacokinetic analysis 2 | Analysis of Area under the plasma concentration versus time curve (AUC) for posaconazole in the given cohort. |
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Inclusion Criteria:
Exclusion Criteria:
- no declaration of consent
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Critically ill patients treated with posaconazole intravenously.
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| Name | Affiliation | Role |
|---|---|---|
| Dominic Wichmann, Prof | Universitätsklinikum Hamburg-Eppendorf | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Center Hamburg-Eppendorf | Hamburg | 20246 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37498488 | Derived | 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. |
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| ID | Term |
|---|---|
| D016638 | Critical Illness |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| 12 months after close out |
| Evaluation of probability of target attainment of posaconazole | Analysis of Monte-Carlo-Simulations in order to asses novel dosing regimens for posaconazole. | 12 months after close out |