- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02805049
Pharmacokinetic Study on Echinocandins for Patients With Septic Shock Following Secondary Peritonitis
January 24, 2019 updated by: Centre Hospitalier Universitaire de Nīmes
The main objective of this study is to describe the pharmacokinetics of the prescribed echinocandins for septic shock with secondary peritonitis for which intra-abdominal fungal infection is suspected or proven.
Study Overview
Detailed Description
The secondary objectives of this study are:
- Determine whether the current recommended doses of caspofungin achieve the Pharmacokinetic/Pharmacodynamic (PK/PD) target for this molecule.
- Determine whether the current recommended doses of micafungin achieve the PK / PD target for this molecule
- Describe the peritoneal concentrations of echinocandins in secondary peritonitis complicated with septic shock
- Identify via modeling PK / PD parameters and based on monte Carlo simulations the optimal dosing regimen for caspofungin and micafungin in this population
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- The emergency inclusion procedure was correctly applied according to French law (signature of consent form by a patient-designated trusted person or a family member, or a medical decision to proceed with patient inclusion if the latter two persons are unavailable) ---- OR ---- signature of the consent form by the patient
- The patient must be insured or beneficiary of a health insurance plan
- The patient is 18 years of age or older
- The patient has beed admitted to the ICU for septic shock accompanying secondary peritonitis
- Patient requiring antifungal treatment via echinocandins (caspofungin or micafungin)
- A venous or arterial access for blood sampling is already in place for routine care
Exclusion Criteria:
- The patient is participating in an interventional study that may affect the results of the present study, or has participated in such a study within the past 3 months
- The patient is under judicial protection, or is an adult under guardianship
- The patient is pregnant, parturient or breastfeeding
- Moribund patient
- Known positive serology for human immunodeficiency virus (HIV)
- Known positive serology for hepatitis C
- Known diagnosis for tuberculosis
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: The study population
The study population consisted of patients admitted to the ICU for septic shock associated with secondary peritonitis and requiring antifungal therapy via echinocandins (micafungin or caspofungin).
|
The patients included in this protocol require routine treatment with caspofungin or micafungin.
Though this intervention is under study, it is not modified by this protocol.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Antifungal treatment plasmatic clearance (L/h)
Time Frame: Day 1
|
Day 1
|
Antifungal treatment plasmatic clearance (L/h)
Time Frame: Days 3-5
|
Days 3-5
|
The volume of distribution (L) corresponding to plasmatic antifungal treatment concentration
Time Frame: Day 1
|
Day 1
|
The volume of distribution (L) corresponding to plasmatic antifungal treatment concentration
Time Frame: Days 3-5
|
Days 3-5
|
Intercompartmental transfer constant for a bi-compartmental model for plasmatic antifungal treatment concentration
Time Frame: Day 1
|
Day 1
|
Intercompartmental transfer constant for a bi-compartmental model for plasmatic antifungal treatment concentration
Time Frame: Days 3-5
|
Days 3-5
|
The area under the curve for plasmatic antifungal treatment concentrations
Time Frame: Day 1
|
Day 1
|
The area under the curve for plasmatic antifungal treatment concentrations
Time Frame: Days 3-5
|
Days 3-5
|
The maximum concentration for plasmatic antifungal treatment concentrations
Time Frame: Day 1
|
Day 1
|
The maximum concentration for plasmatic antifungal treatment concentrations
Time Frame: Days 3-5
|
Days 3-5
|
The minimum concentration for plasmatic antifungal treatment concentrations
Time Frame: Day 1
|
Day 1
|
The minimum concentration for plasmatic antifungal treatment concentrations
Time Frame: Days 3-5
|
Days 3-5
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The target Pharmacokinetic/Pharmacodynamic ratio for caspofungin
Time Frame: Day 1
|
corresponds to: area under the curve / minimum inhibitory concentration >865
|
Day 1
|
The target Pharmacokinetic/Pharmacodynamic ratio for caspofungin
Time Frame: Days 3-5
|
corresponds to: area under the curve / minimum inhibitory concentration >865
|
Days 3-5
|
The target Pharmacokinetic/Pharmacodynamic ratio for micafungin
Time Frame: Day 1
|
corresponds to: area under the curve / minimum inhibitory concentration >285 et 3000
|
Day 1
|
The target Pharmacokinetic/Pharmacodynamic ratio for micafungin
Time Frame: Days 3-5
|
corresponds to: area under the curve / minimum inhibitory concentration >285 et 3000
|
Days 3-5
|
The area under the curve for peritoneal antifungal treatment concentrations
Time Frame: Day 1
|
Day 1
|
|
The area under the curve for peritoneal antifungal treatment concentrations
Time Frame: Days 3-5
|
Days 3-5
|
|
The maximum concentration for peritoneal antifungal treatment concentrations
Time Frame: Day 1
|
Day 1
|
|
The maximum concentration for peritoneal antifungal treatment concentrations
Time Frame: Days 3-5
|
Days 3-5
|
|
The minimum concentration for peritoneal antifungal treatment concentrations
Time Frame: Day 1
|
Day 1
|
|
The minimum concentration for peritoneal antifungal treatment concentrations
Time Frame: Days 3-5
|
Days 3-5
|
|
The probability of attaining the targeted Pharmacokinetic/Pharmacodynamic ratio
Time Frame: Day 1
|
Day 1
|
|
The probability of attaining the targeted Pharmacokinetic/Pharmacodynamic ratio
Time Frame: Days 3-5
|
Days 3-5
|
|
The fraction of the probability of attaining the targeted Pharmacokinetic/Pharmacodynamic ratio
Time Frame: Day 1
|
Day 1
|
|
The fraction of the probability of attaining the targeted Pharmacokinetic/Pharmacodynamic ratio
Time Frame: Days 3-5
|
Days 3-5
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 28, 2017
Primary Completion (Actual)
June 23, 2018
Study Completion (Actual)
June 23, 2018
Study Registration Dates
First Submitted
June 15, 2016
First Submitted That Met QC Criteria
June 15, 2016
First Posted (Estimate)
June 17, 2016
Study Record Updates
Last Update Posted (Actual)
January 25, 2019
Last Update Submitted That Met QC Criteria
January 24, 2019
Last Verified
January 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- Infections
- Systemic Inflammatory Response Syndrome
- Inflammation
- Peritoneal Diseases
- Sepsis
- Intraabdominal Infections
- Shock, Septic
- Shock
- Peritonitis
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Antifungal Agents
- Micafungin
- Caspofungin
- Echinocandins
Other Study ID Numbers
- LOCAL/2016/CR-01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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