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
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