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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02805049




Registration number
NCT02805049
Ethics application status
Date submitted
15/06/2016
Date registered
17/06/2016
Date last updated
25/01/2019

Titles & IDs
Public title
Pharmacokinetic Study on Echinocandins for Patients With Septic Shock Following Secondary Peritonitis
Scientific title
Pharmacokinetic Study on Echinocandins for Patients With Septic Shock Following Secondary Peritonitis
Secondary ID [1] 0 0
LOCAL/2016/CR-01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Septic Shock 0 0
Peritonitis 0 0
Condition category
Condition code
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Echinocandins

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).


Treatment: Drugs: Echinocandins
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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Antifungal treatment plasmatic clearance (L/h)
Timepoint [1] 0 0
Day 1
Primary outcome [2] 0 0
Antifungal treatment plasmatic clearance (L/h)
Timepoint [2] 0 0
Days 3-5
Primary outcome [3] 0 0
The volume of distribution (L) corresponding to plasmatic antifungal treatment concentration
Timepoint [3] 0 0
Day 1
Primary outcome [4] 0 0
The volume of distribution (L) corresponding to plasmatic antifungal treatment concentration
Timepoint [4] 0 0
Days 3-5
Primary outcome [5] 0 0
Intercompartmental transfer constant for a bi-compartmental model for plasmatic antifungal treatment concentration
Timepoint [5] 0 0
Day 1
Primary outcome [6] 0 0
Intercompartmental transfer constant for a bi-compartmental model for plasmatic antifungal treatment concentration
Timepoint [6] 0 0
Days 3-5
Primary outcome [7] 0 0
The area under the curve for plasmatic antifungal treatment concentrations
Timepoint [7] 0 0
Day 1
Primary outcome [8] 0 0
The area under the curve for plasmatic antifungal treatment concentrations
Timepoint [8] 0 0
Days 3-5
Primary outcome [9] 0 0
The maximum concentration for plasmatic antifungal treatment concentrations
Timepoint [9] 0 0
Day 1
Primary outcome [10] 0 0
The maximum concentration for plasmatic antifungal treatment concentrations
Timepoint [10] 0 0
Days 3-5
Primary outcome [11] 0 0
The minimum concentration for plasmatic antifungal treatment concentrations
Timepoint [11] 0 0
Day 1
Primary outcome [12] 0 0
The minimum concentration for plasmatic antifungal treatment concentrations
Timepoint [12] 0 0
Days 3-5
Secondary outcome [1] 0 0
The target Pharmacokinetic/Pharmacodynamic ratio for caspofungin
Timepoint [1] 0 0
Day 1
Secondary outcome [2] 0 0
The target Pharmacokinetic/Pharmacodynamic ratio for caspofungin
Timepoint [2] 0 0
Days 3-5
Secondary outcome [3] 0 0
The target Pharmacokinetic/Pharmacodynamic ratio for micafungin
Timepoint [3] 0 0
Day 1
Secondary outcome [4] 0 0
The target Pharmacokinetic/Pharmacodynamic ratio for micafungin
Timepoint [4] 0 0
Days 3-5
Secondary outcome [5] 0 0
The area under the curve for peritoneal antifungal treatment concentrations
Timepoint [5] 0 0
Day 1
Secondary outcome [6] 0 0
The area under the curve for peritoneal antifungal treatment concentrations
Timepoint [6] 0 0
Days 3-5
Secondary outcome [7] 0 0
The maximum concentration for peritoneal antifungal treatment concentrations
Timepoint [7] 0 0
Day 1
Secondary outcome [8] 0 0
The maximum concentration for peritoneal antifungal treatment concentrations
Timepoint [8] 0 0
Days 3-5
Secondary outcome [9] 0 0
The minimum concentration for peritoneal antifungal treatment concentrations
Timepoint [9] 0 0
Day 1
Secondary outcome [10] 0 0
The minimum concentration for peritoneal antifungal treatment concentrations
Timepoint [10] 0 0
Days 3-5
Secondary outcome [11] 0 0
The probability of attaining the targeted Pharmacokinetic/Pharmacodynamic ratio
Timepoint [11] 0 0
Day 1
Secondary outcome [12] 0 0
The probability of attaining the targeted Pharmacokinetic/Pharmacodynamic ratio
Timepoint [12] 0 0
Days 3-5
Secondary outcome [13] 0 0
The fraction of the probability of attaining the targeted Pharmacokinetic/Pharmacodynamic ratio
Timepoint [13] 0 0
Day 1
Secondary outcome [14] 0 0
The fraction of the probability of attaining the targeted Pharmacokinetic/Pharmacodynamic ratio
Timepoint [14] 0 0
Days 3-5

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
28/01/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
23/06/2018
Sample size
Target
Accrual to date
Final
24
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Royal Brisbane Women's Hospital - Herston
Recruitment postcode(s) [1] 0 0
4029 - Herston
Recruitment outside Australia
Country [1] 0 0
France
State/province [1] 0 0
Nîmes Cedex 09

Funding & Sponsors
Primary sponsor type
Other
Name
Centre Hospitalier Universitaire de Nimes
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02805049
Trial related presentations / publications
Singer M, Deutschman CS, Seymour CW, Shankar-Hari M, Annane D, Bauer M, Bellomo R, Bernard GR, Chiche JD, Coopersmith CM, Hotchkiss RS, Levy MM, Marshall JC, Martin GS, Opal SM, Rubenfeld GD, van der Poll T, Vincent JL, Angus DC. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016 Feb 23;315(8):801-10. doi: 10.1001/jama.2016.0287.
Public notes

Contacts
Principal investigator
Name 0 0
Claire Roger, MD
Address 0 0
Centre Hospitalier Universitaire de Nîmes
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02805049