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Pharmacokinetics of Caspofungin After One Dose in Patients With Liver Failure

Information source: Erasme University Hospital
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Bacterial Infections and Mycoses; Liver Disease

Intervention: Caspofungin 70 mg (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Erasme University Hospital

Official(s) and/or principal investigator(s):
Frédérique JACOBS, MD,PhD, Principal Investigator, Affiliation: Erasme University Hospital

Overall contact:
Frédérique JACOBS, MD, PhD, Phone: +3225553111, Ext: 4433, Email: frederique.jacobs@erasme.ulb.ac.be

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.

Clinical Details

Official title: Pharmacokinetics of Caspofungin After One Dose in Patients With Liver Failure

Study design: Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label

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

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Liver failure Child-Pugh B and C

Exclusion Criteria:

- Cachexia (BMI < 15 kg/m²)

- Pregnancy

- HIV

- Hepatitis C patients

Locations and Contacts

Frédérique JACOBS, MD, PhD, Phone: +3225553111, Ext: 4433, Email: frederique.jacobs@erasme.ulb.ac.be

Erasme University Hospital, Brussels 1070, Belgium; Recruiting
Frédérique JACOBS, MD, PhD, Phone: +3225553111, Ext: 4433, Email: frederique.jacobs@erasme.ulb.ac.be
Frédérique JACOBS, MD, PhD, Principal Investigator
Additional Information

Starting date: September 2013
Last updated: October 23, 2013

Page last updated: August 20, 2015

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