Bacterial Infections and Mycoses, Liver Disease
Conditions
Brief summary
The objective of this study is to conduct a population pharmacokinetic analysis of caspofungin in a population of patients with moderate and severe acute alcoholic hepatitis or liver disease with Child-Pugh score B and C in order to better characterize pharmacokinetic parameters in case of moderate and severe liver dysfunction.
Detailed description
patients admitted for alcoholic hepatitis or decompensated cirrhosis and Child-Pugh score 7-9 and 10-15 will be included; all patients without invasive aspergillosis.
Interventions
DRUGCaspofungin 70 mg
Intravenous use
Sponsors
Erasme University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Liver failure Child-Pugh B and C
Exclusion criteria
* Cachexia (BMI \< 15 kg/m²) * Pregnancy * HIV * Hepatitis C patients
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measurement of serum caspofungine concentrations to determine the pharmacokinetic parameters of Caspofungin in patients with liver failure | 14 days | one dose of caspofungin will be given to patients with hepatic failure. Serum sampling will be performed during 96 hours. Measurements of caspofungin in the serum will be performed to study the pharmacokinetics of this drugs and will be compared with pharmacokinetics of subjects with normal liver function. For safety, patients will be followed during 14 days. |
Countries
Belgium
Outcome results
None listed