Pharmacokinetics of Caspofungin After One Dose in Patients With Liver Failure
- Conditions
- Bacterial Infections and MycosesLiver Disease
- Interventions
- Registration Number
- NCT01968395
- Lead Sponsor
- Erasme University Hospital
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
- Liver failure Child-Pugh B and C
- Cachexia (BMI < 15 kg/m²)
- Pregnancy
- HIV
- Hepatitis C patients
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Caspofungin 70 mg Caspofungin 70 mg Infusion of one dose of Caspofungin 70 mg
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Erasme University Hospital
🇧🇪Brussels, Belgium