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Pharmacokinetic Study on Echinocandins for Patients With Septic Shock Following Secondary Peritonitis

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ClinicalTrials.gov Identifier: NCT02805049
Recruitment Status : Completed
First Posted : June 17, 2016
Last Update Posted : January 25, 2019
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes

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.

Condition or disease Intervention/treatment Phase
Septic Shock Peritonitis Drug: Echinocandins Phase 4

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pharmacokinetic Study on Echinocandins for Patients With Septic Shock Following Secondary Peritonitis
Actual Study Start Date : January 28, 2017
Actual Primary Completion Date : June 23, 2018
Actual Study Completion Date : June 23, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock

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).
Drug: 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.
Other Name: caspofungin or micafungin




Primary Outcome Measures :
  1. Antifungal treatment plasmatic clearance (L/h) [ Time Frame: Day 1 ]
  2. Antifungal treatment plasmatic clearance (L/h) [ Time Frame: Days 3-5 ]
  3. The volume of distribution (L) corresponding to plasmatic antifungal treatment concentration [ Time Frame: Day 1 ]
  4. The volume of distribution (L) corresponding to plasmatic antifungal treatment concentration [ Time Frame: Days 3-5 ]
  5. Intercompartmental transfer constant for a bi-compartmental model for plasmatic antifungal treatment concentration [ Time Frame: Day 1 ]
  6. Intercompartmental transfer constant for a bi-compartmental model for plasmatic antifungal treatment concentration [ Time Frame: Days 3-5 ]
  7. The area under the curve for plasmatic antifungal treatment concentrations [ Time Frame: Day 1 ]
  8. The area under the curve for plasmatic antifungal treatment concentrations [ Time Frame: Days 3-5 ]
  9. The maximum concentration for plasmatic antifungal treatment concentrations [ Time Frame: Day 1 ]
  10. The maximum concentration for plasmatic antifungal treatment concentrations [ Time Frame: Days 3-5 ]
  11. The minimum concentration for plasmatic antifungal treatment concentrations [ Time Frame: Day 1 ]
  12. The minimum concentration for plasmatic antifungal treatment concentrations [ Time Frame: Days 3-5 ]

Secondary Outcome Measures :
  1. The target Pharmacokinetic/Pharmacodynamic ratio for caspofungin [ Time Frame: Day 1 ]
    corresponds to: area under the curve / minimum inhibitory concentration >865

  2. The target Pharmacokinetic/Pharmacodynamic ratio for caspofungin [ Time Frame: Days 3-5 ]
    corresponds to: area under the curve / minimum inhibitory concentration >865

  3. The target Pharmacokinetic/Pharmacodynamic ratio for micafungin [ Time Frame: Day 1 ]
    corresponds to: area under the curve / minimum inhibitory concentration >285 et 3000

  4. The target Pharmacokinetic/Pharmacodynamic ratio for micafungin [ Time Frame: Days 3-5 ]
    corresponds to: area under the curve / minimum inhibitory concentration >285 et 3000

  5. The area under the curve for peritoneal antifungal treatment concentrations [ Time Frame: Day 1 ]
  6. The area under the curve for peritoneal antifungal treatment concentrations [ Time Frame: Days 3-5 ]
  7. The maximum concentration for peritoneal antifungal treatment concentrations [ Time Frame: Day 1 ]
  8. The maximum concentration for peritoneal antifungal treatment concentrations [ Time Frame: Days 3-5 ]
  9. The minimum concentration for peritoneal antifungal treatment concentrations [ Time Frame: Day 1 ]
  10. The minimum concentration for peritoneal antifungal treatment concentrations [ Time Frame: Days 3-5 ]
  11. The probability of attaining the targeted Pharmacokinetic/Pharmacodynamic ratio [ Time Frame: Day 1 ]
  12. The probability of attaining the targeted Pharmacokinetic/Pharmacodynamic ratio [ Time Frame: Days 3-5 ]
  13. The fraction of the probability of attaining the targeted Pharmacokinetic/Pharmacodynamic ratio [ Time Frame: Day 1 ]
  14. The fraction of the probability of attaining the targeted Pharmacokinetic/Pharmacodynamic ratio [ Time Frame: Days 3-5 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02805049


Locations
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Australia
Royal Brisbane Women's Hospital
Herston, Australia, 4029
France
CHU de Nîmes - Hôpital Universitaire Carémeau
Nîmes Cedex 09, France, 30029
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Investigators
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Principal Investigator: Claire Roger, MD Centre Hospitalier Universitaire de Nîmes

Publications:
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Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT02805049     History of Changes
Other Study ID Numbers: LOCAL/2016/CR-01
First Posted: June 17, 2016    Key Record Dates
Last Update Posted: January 25, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Shock
Shock, Septic
Peritonitis
Pathologic Processes
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Intraabdominal Infections
Peritoneal Diseases
Digestive System Diseases
Caspofungin
Micafungin
Echinocandins
Antifungal Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action