Back to resultsPharmacokinetics of Caspofungin After One Dose in Patients With Liver Failure
Primary Purpose
Bacterial Infections and Mycoses, Liver Disease
Status
Completed
Phase
Phase 4
Locations
Belgium
Study Type
Interventional
Intervention
Caspofungin 70 mg
Sponsored by
About this trial
This is an interventional other trial for Bacterial Infections and Mycoses
Eligibility Criteria
Inclusion Criteria:
- Liver failure Child-Pugh B and C
Exclusion Criteria:
- Cachexia (BMI < 15 kg/m²)
- Pregnancy
- HIV
- Hepatitis C patients
Sites / Locations
- Erasme University Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Caspofungin 70 mg
Arm Description
Infusion of one dose of Caspofungin 70 mg
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01968395
First Posted
September 25, 2013
Last Updated
February 14, 2019
Sponsor
Erasme University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01968395
Brief Title
Pharmacokinetics of Caspofungin After One Dose in Patients With Liver Failure
Official Title
Pharmacokinetics of Caspofungin After One Dose in Patients With Liver Failure
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
October 21, 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Erasme University Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bacterial Infections and Mycoses, Liver Disease
7. Study Design
Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Caspofungin 70 mg
Arm Type
Other
Arm Description
Infusion of one dose of Caspofungin 70 mg
Intervention Type
Drug
Intervention Name(s)
Caspofungin 70 mg
Other Intervention Name(s)
Cancidas
Intervention Description
Intravenous use
Primary Outcome Measure Information:
Title
Measurement of serum caspofungine concentrations to determine the pharmacokinetic parameters of Caspofungin in patients with liver failure
Description
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.
Time Frame
14 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Liver failure Child-Pugh B and C
Exclusion Criteria:
Cachexia (BMI < 15 kg/m²)
Pregnancy
HIV
Hepatitis C patients
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frédérique JACOBS, MD,PhD
Organizational Affiliation
Erasme University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Erasme University Hospital
City
Brussels
ZIP/Postal Code
1070
Country
Belgium
12. IPD Sharing Statement
Citations:
PubMed Identifier
29860319
Citation
Gustot T, Ter Heine R, Brauns E, Cotton F, Jacobs F, Bruggemann 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.
Results Reference
result
Learn more about this trial
Pharmacokinetics of Caspofungin After One Dose in Patients With Liver Failure
We'll reach out to this number within 24 hrs