Evaluation of the Pharmacokinetics of Caspofungin in ICU Patients (CaspoKin)
Primary Purpose
Shock
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Caspofungin
Sponsored by
About this trial
This is an interventional treatment trial for Shock focused on measuring Intensive Care Unit, Shock, Antifungal agent, Pharmacokinetics, Sepsis
Eligibility Criteria
Inclusion Criteria:
- Adult patients (age > 18 y.o)
- Either preemptive, empirical or curative prescription of Caspofungin by one of the ICUs' attending physician
- Requiring vasopressors
- Admission in one of the participating ICUs.
Exclusion Criteria:
- Pregnancy
- Lack of affiliation to the National Medical Insurance
- Previous inclusion in the study
- Inclusion in a concomitant study that may interact with the current study
Sites / Locations
- CHU de CLERMONT-FERRAND
- Hôpital Saint-Louis
- CHU de SAINT-ETIENNE
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
caspofungin
Arm Description
Caspofungin will be administered according to the international recommendation.
Outcomes
Primary Outcome Measures
Caspofungin pharmacokinetic : clearance (ml.min-1)
Caspofungin pharmacokinetic : volume of distribution (mL)
Secondary Outcome Measures
Caspofungin trough concentration
proportion of patients for whom the trough concentrations are lower than the MIC (Minimum Inhibitory Concentration) 90 of Candida ( 1mg / L)
Full Information
NCT ID
NCT02596984
First Posted
November 3, 2015
Last Updated
June 12, 2019
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
Collaborators
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT02596984
Brief Title
Evaluation of the Pharmacokinetics of Caspofungin in ICU Patients
Acronym
CaspoKin
Official Title
Evaluation of the Pharmacokinetics of Caspofungin in ICU Patients
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
March 16, 2015 (Actual)
Primary Completion Date
May 2018 (Actual)
Study Completion Date
May 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Saint Etienne
Collaborators
Merck Sharp & Dohme LLC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Although the pharmacokinetics of Caspofungin has been studied in healthy subjects and patients, only a few studies have been performed in critically-ill patients. In these patients several factors, including sepsis, shock, increased distribution volume, hepatic dysfunction and hypoalbuminemia may result in dramatic changes in antibiotic concentrations and pharmacokinetics. Caspofungin pharmacokinetic data is scarce and are results mainly from case series or animal studies. Thus, studies performed so far show Caspofungin trough concentrations either decreased, similar to usual value in non-critically ill patients or increased. One of these studies suggested that body weight and hypoalbuminemia may be the main factors associated with Caspofungin pharmacokinetic variability. Pharmacokinetic parameters of caspofungin in pigs with hypovolemic shock suggested the peripheral volume of distribution of caspofungin and intercompartmental clearance to be higher than in healthy animals. These results are however preliminary and cannot be extrapolated suggesting further clinical studies in human to be needed.
The primary objective of this study is to assess Caspofungin trough concentrations and pharmacokinetics in critically-ill patients requiring vasopressors.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shock
Keywords
Intensive Care Unit, Shock, Antifungal agent, Pharmacokinetics, Sepsis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
caspofungin
Arm Type
Experimental
Arm Description
Caspofungin will be administered according to the international recommendation.
Intervention Type
Drug
Intervention Name(s)
Caspofungin
Intervention Description
Either preemptive, empirical or curative prescription of Caspofungin by one of the ICUs' attending physician. Caspofungin will be administered according to the international recommendation
Primary Outcome Measure Information:
Title
Caspofungin pharmacokinetic : clearance (ml.min-1)
Time Frame
day 2 - day 3 - day 4
Title
Caspofungin pharmacokinetic : volume of distribution (mL)
Time Frame
day 2 - day 3 - day 4
Secondary Outcome Measure Information:
Title
Caspofungin trough concentration
Time Frame
day 2 - day 3 - day 4
Title
proportion of patients for whom the trough concentrations are lower than the MIC (Minimum Inhibitory Concentration) 90 of Candida ( 1mg / L)
Time Frame
day 2 - day 3 - day 4
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult patients (age > 18 y.o)
Either preemptive, empirical or curative prescription of Caspofungin by one of the ICUs' attending physician
Requiring vasopressors
Admission in one of the participating ICUs.
Exclusion Criteria:
Pregnancy
Lack of affiliation to the National Medical Insurance
Previous inclusion in the study
Inclusion in a concomitant study that may interact with the current study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael DARMON, MD PhD
Organizational Affiliation
CHU de SAINT-ETIENNE
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de CLERMONT-FERRAND
City
Clermont-ferrand
ZIP/Postal Code
63000
Country
France
Facility Name
Hôpital Saint-Louis
City
Paris
ZIP/Postal Code
75010
Country
France
Facility Name
CHU de SAINT-ETIENNE
City
Saint-etienne
ZIP/Postal Code
42000
Country
France
12. IPD Sharing Statement
Learn more about this trial
Evaluation of the Pharmacokinetics of Caspofungin in ICU Patients
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