Pharmacokinetic of Posaconazole in Critically Ill Patients
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 |
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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
Arms and Interventions
Arm | Intervention/Treatment |
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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).
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Outcome Measures
Primary Outcome Measures
- Posaconazole Drug Exposure [seven days from therapystart]
Measurement of posaconazole concentration in serum
Secondary Outcome Measures
- population-pharmacokinetic analysis 1 [12 months after close out]
Analysis of Peak Plasma Concentration (Cmax) for posaconazole in the given cohort.
- 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.
- 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
Inclusion Criteria:
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treatment with intravenous posaconazole
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critically ill patient
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written declaration of consent
Exclusion Criteria:
- no declaration of consent
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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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.- PV7263