Critical Illness, Therapeutic Drug Monitoring
Conditions
Brief summary
The posaconazole pharmacokinetic in critically ill patients will be studied in a prospective, non-interventional, monocentric observational trial.
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.
Interventions
OTHERPosaconazole Therapeutic Drug Monitoring
Therapeutic Drug Monitoring is performed by measuring posaconazole concentrations in serum on seven consecutive days (anticipated).
Sponsors
Universitätsklinikum Hamburg-Eppendorf
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* treatment with intravenous posaconazole * critically ill patient * written declaration of consent
Exclusion criteria
\- no declaration of consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Posaconazole Drug Exposure | seven days from therapystart | Measurement of posaconazole concentration in serum |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Germany
Outcome results
None listed