Serum pharmacokinetics of Caspofungin in patients with liver failure.

Conditions: The patient admitted for alcoholic hepatitis or decompensated cirrhosis (Child-Pugh score of 10-15) presenting with invasive aspergillosis (proven or probable) and treated by caspofungin.
MedDRA version: 14.1Level: LLTClassification code 10024678Term: Liver failureSystem Organ Class: 100000004871
Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

Registration Number: EUCTR2012-004031-23-BE

Lead Sponsor: Hopital Erasme

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

All successive patients with liver failure due to alcoholic hepatitis or decompensated cirrhosis admitted in the hospital will be included.
The inclusion criteria for patients with alcoholic hepatitis are
1.age of 18 or older
2.average alcohol intake of more than 50g per day during the 3 months before enrolment
3.a Madrey’s discriminant function of 32 or more
4.a liver biopsy consistent with alcoholic hepatitis (Mallory bodies surrounded by polymorphonuclear neutrophils)

The Child-Pugh score will determine the inclusion criteria for liver cirrhosis: patient will be included if the score is between 10 and 15 (score C)

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 7
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 3

Exclusion Criteria

-Patients with cachexia (Body mass index < 15kg/m²)
-Pregnant women

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The objective of the 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 C in order to better characterize PK parameters in case of moderate and severe liver dysfunction.;Secondary Objective: NA;Primary end point(s): NA;Timepoint(s) of evaluation of this end point: NA

Secondary Outcome Measures