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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	12 December 2020
Main ID:	NCT02805049
Date of registration:	15/06/2016
Prospective Registration:	Yes
Primary sponsor:	Centre Hospitalier Universitaire de Nimes
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
Date of first enrolment:	January 28, 2017
Target sample size:	24
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT02805049
Study type:	Interventional
Study design:	Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
Phase:	Phase 4

Countries of recruitment
Australia	France

Contacts

Name:	Claire Roger, MD
Address:
Telephone:
Email:
Affiliation:	Centre Hospitalier Universitaire de Nîmes

Key inclusion & exclusion criteria

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

Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Peritonitis

Septic Shock

Intervention(s)

Drug: Echinocandins

Primary Outcome(s)

The minimum concentration for plasmatic antifungal treatment concentrations [Time Frame: Days 3-5]

The volume of distribution (L) corresponding to plasmatic antifungal treatment concentration [Time Frame: Days 3-5]

The area under the curve for plasmatic antifungal treatment concentrations [Time Frame: Day 1]

The maximum concentration for plasmatic antifungal treatment concentrations [Time Frame: Day 1]

Intercompartmental transfer constant for a bi-compartmental model for plasmatic antifungal treatment concentration [Time Frame: Day 1]

The volume of distribution (L) corresponding to plasmatic antifungal treatment concentration [Time Frame: Day 1]

Antifungal treatment plasmatic clearance (L/h) [Time Frame: Days 3-5]

The maximum concentration for plasmatic antifungal treatment concentrations [Time Frame: Days 3-5]

Antifungal treatment plasmatic clearance (L/h) [Time Frame: Day 1]

Intercompartmental transfer constant for a bi-compartmental model for plasmatic antifungal treatment concentration [Time Frame: Days 3-5]

The area under the curve for plasmatic antifungal treatment concentrations [Time Frame: Days 3-5]

The minimum concentration for plasmatic antifungal treatment concentrations [Time Frame: Day 1]

Secondary Outcome(s)

The fraction of the probability of attaining the targeted Pharmacokinetic/Pharmacodynamic ratio [Time Frame: Day 1]

The target Pharmacokinetic/Pharmacodynamic ratio for caspofungin [Time Frame: Days 3-5]

The target Pharmacokinetic/Pharmacodynamic ratio for micafungin [Time Frame: Days 3-5]

The maximum concentration for peritoneal antifungal treatment concentrations [Time Frame: Days 3-5]

The maximum concentration for peritoneal antifungal treatment concentrations [Time Frame: Day 1]

The fraction of the probability of attaining the targeted Pharmacokinetic/Pharmacodynamic ratio [Time Frame: Days 3-5]

The minimum concentration for peritoneal antifungal treatment concentrations [Time Frame: Days 3-5]

The probability of attaining the targeted Pharmacokinetic/Pharmacodynamic ratio [Time Frame: Days 3-5]

The target Pharmacokinetic/Pharmacodynamic ratio for caspofungin [Time Frame: Day 1]

The area under the curve for peritoneal antifungal treatment concentrations [Time Frame: Day 1]

The probability of attaining the targeted Pharmacokinetic/Pharmacodynamic ratio [Time Frame: Day 1]

The area under the curve for peritoneal antifungal treatment concentrations [Time Frame: Days 3-5]

The minimum concentration for peritoneal antifungal treatment concentrations [Time Frame: Day 1]

The target Pharmacokinetic/Pharmacodynamic ratio for micafungin [Time Frame: Day 1]

Secondary ID(s)

LOCAL/2016/CR-01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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