Pharmacokinetics of Caspofungin After One Dose in Patients With Liver Failure

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.

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Key information

Conditions

Bacterial Infections and Mycoses Digestive System Diseases Infections Liver Disease Liver Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Erasme University Hospital

Brussels, 1070, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Liver failure Child-Pugh B and C

Exclusion criteria

Cachexia (BMI < 15 kg/m²)
Pregnancy
HIV
Hepatitis C patients

Treatment and study plan

Caspofungin 70 mg

Drug

Intravenous use

Other names: Cancidas

Primary outcomes

Measurement of serum caspofungine concentrations to determine the pharmacokinetic parameters of Caspofungin in patients with liver failure

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Erasme University Hospital

Other

Registry information

Important dates

Study start: 2013
Primary completion: 2014
Study completion: 2014
First posted: Oct 24, 2013
Registry last updated: Feb 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed