Pharmacokinetics of Caspofungin After One Dose in Patients With Liver Failure

Liver Disease Clinical Trial

Official title:

Pharmacokinetics of Caspofungin After One Dose in Patients With Liver Failure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01968395
• Other study ID #: E2013_PK_CASPO70_LIVERFAILURE
• Status: Completed
• Phase: Phase 4
• Start date: September 2013
• Est. completion date: October 21, 2014

Study information

• Verified date: June 2018
• Source: Erasme University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 21, 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Liver failure Child-Pugh B and C

Exclusion Criteria:

• Cachexia (BMI < 15 kg/m²)

• Pregnancy

• HIV

• Hepatitis C patients

Related Conditions & MeSH terms

• Bacterial Infections
• Bacterial Infections and Mycoses
• Hepatic Insufficiency
• Liver Disease
• Liver Diseases
• Liver Failure
• Mycoses

Intervention

Drug:
• Caspofungin 70 mg
Intravenous use

Locations

Country	Name	City	State
Belgium	Erasme University Hospital	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Erasme University Hospital

Country where clinical trial is conducted

Belgium, 

References & Publications (1)

Gustot T, Ter Heine R, Brauns E, Cotton F, Jacobs F, Brüggemann RJ. Caspofungin dosage adjustments are not required for patients with Child-Pugh B or C cirrhosis. J Antimicrob Chemother. 2018 Sep 1;73(9):2493-2496. doi: 10.1093/jac/dky189. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measurement of serum caspofungine concentrations to determine the pharmacokinetic parameters of Caspofungin in patients with liver failure	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.	14 days