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出境医 / 临床实验 / Alteration of the Immune Response in Bacterial Infection (ARIIBACT)

Alteration of the Immune Response in Bacterial Infection (ARIIBACT)

Study Description
Brief Summary:

The pilot study "ARIIBO" was conducted to analyze changes in immune parameters reported in obese subjects, which had never been the subject of a global study outside of an infectious context, and studied in period septic only sporadically. This study was intended to contribute to a better understanding of the probably adverse impact of obesity on the immune response to bacterial infections, and to describe a specific immunological profile of an infectious excess risk in obese subjects.

In terms of infection, obesity is a risk factor due to "mechanical" and pharmacodynamic variations, but also to the immune system. One of the best studied immunological parameters in obese patients, leptin resistance, is associated with a decrease in innate and adaptive immunity through a modification of the lymphocyte and cytokine profile.

It is important to compare the data collected in obese patients infected (first study called "ARIIBO"), with those of non-obese subjects presenting the same type of infection, which will be included in the study "ARIIBACT"


Condition or disease Intervention/treatment Phase
Infection Biological: blood sample Not Applicable

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Alteration of the Immune Response in Bacterial Infection
Estimated Study Start Date : May 1, 2019
Estimated Primary Completion Date : May 1, 2020
Estimated Study Completion Date : September 1, 2020
Arms and Interventions
Arm Intervention/treatment
Experimental: Interventional arm
blood sample before, during and after treatment for infection
 Biological: blood sample
blood sample before, during and after infection treatment
Outcome Measures
Primary Outcome Measures :
  1. cytokin analysis (IL-6, IL-10, IL-17, TNFα, IFNγ) [ Time Frame: 1 month ]
    Description of an immunological profile of inflammation using current inflammatory cytokines during sepsis in non-obese subjects in comparison with this same profile in obese subjects

  2. adipokin analysis (leptine, adiponectine) [ Time Frame: 1 month ]
    Description of the kinetics of 2 cytokines more speficically involved in obesity (leptine, adipokinine) during sepsis in non-obese subjects in comparison with this same profile in obese subjects

  3. leptin polymorphism analysis [ Time Frame: 1 month ]
    Description of the genetic polymorphism of leptine and leptine receptor in non-obese subjects in comparison with this same profile in obese subjects


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age between 18 and 80 years
  • BMI 18 to 25
  • presence of a bacterial infection
  • pneumopathy (documented or probable)
  • acute pyelonephritis / prostatitis
  • skin and soft tissue infection (erysipelas, fasciitis, excluding pressure ulcers)
  • cholecystitis / cholangitis,
  • surgical site infection
  • signed informed consent

Exclusion Criteria:

  • patients with documented viral, parasitic or mycotic infections
  • patients with bacterial infection> 4 weeks (eg endocarditis, osteoarticular infections)
  • patients followed in intensive unit care
  • patients with progressive cancerous pathology or malignant hemopathy diagnosed in the previous five years
  • patients with systemic diseases (connective tissue diseases, vasculitis)
  • known immunodepression syndrome (CVID, HIV ...)
  • immunosuppressive therapy in progress until less than one month before inclusion (corticosteroids, DMARDs, biotherapies, hydroxychloroquine)
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Meckenstock +331 39 63 93 19 rmeckenstock@ch-versailles.fr
Contact: Laure Morisset +33139239785 lmorisset@ch-versailles.fr

Locations
Layout table for location information
France
CH Versailles
Le Chesnay, France
Contact: Meckenstock         
Sponsors and Collaborators
Versailles Hospital
Tracking Information
First Submitted Date  ICMJE April 15, 2019
First Posted Date  ICMJE May 13, 2019
Last Update Posted Date May 13, 2019
Estimated Study Start Date  ICMJE May 1, 2019
Estimated Primary Completion Date May 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 9, 2019)
  • cytokin analysis (IL-6, IL-10, IL-17, TNFα, IFNγ) [ Time Frame: 1 month ]
    Description of an immunological profile of inflammation using current inflammatory cytokines during sepsis in non-obese subjects in comparison with this same profile in obese subjects
  • adipokin analysis (leptine, adiponectine) [ Time Frame: 1 month ]
    Description of the kinetics of 2 cytokines more speficically involved in obesity (leptine, adipokinine) during sepsis in non-obese subjects in comparison with this same profile in obese subjects
  • leptin polymorphism analysis [ Time Frame: 1 month ]
    Description of the genetic polymorphism of leptine and leptine receptor in non-obese subjects in comparison with this same profile in obese subjects
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Alteration of the Immune Response in Bacterial Infection
Official Title  ICMJE Alteration of the Immune Response in Bacterial Infection
Brief Summary

The pilot study "ARIIBO" was conducted to analyze changes in immune parameters reported in obese subjects, which had never been the subject of a global study outside of an infectious context, and studied in period septic only sporadically. This study was intended to contribute to a better understanding of the probably adverse impact of obesity on the immune response to bacterial infections, and to describe a specific immunological profile of an infectious excess risk in obese subjects.

In terms of infection, obesity is a risk factor due to "mechanical" and pharmacodynamic variations, but also to the immune system. One of the best studied immunological parameters in obese patients, leptin resistance, is associated with a decrease in innate and adaptive immunity through a modification of the lymphocyte and cytokine profile.

It is important to compare the data collected in obese patients infected (first study called "ARIIBO"), with those of non-obese subjects presenting the same type of infection, which will be included in the study "ARIIBACT"
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Infection
Intervention  ICMJE Biological: blood sample
blood sample before, during and after infection treatment
Study Arms  ICMJE Experimental: Interventional arm
blood sample before, during and after treatment for infection
Intervention: Biological: blood sample
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: May 9, 2019) 		15
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 1, 2020
Estimated Primary Completion Date May 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • age between 18 and 80 years
  • BMI 18 to 25
  • presence of a bacterial infection
  • pneumopathy (documented or probable)
  • acute pyelonephritis / prostatitis
  • skin and soft tissue infection (erysipelas, fasciitis, excluding pressure ulcers)
  • cholecystitis / cholangitis,
  • surgical site infection
  • signed informed consent

Exclusion Criteria:

  • patients with documented viral, parasitic or mycotic infections
  • patients with bacterial infection> 4 weeks (eg endocarditis, osteoarticular infections)
  • patients followed in intensive unit care
  • patients with progressive cancerous pathology or malignant hemopathy diagnosed in the previous five years
  • patients with systemic diseases (connective tissue diseases, vasculitis)
  • known immunodepression syndrome (CVID, HIV ...)
  • immunosuppressive therapy in progress until less than one month before inclusion (corticosteroids, DMARDs, biotherapies, hydroxychloroquine)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03948308
Other Study ID Numbers  ICMJE P17/03_ARIIBACT
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Roderick Meckenstock, Versailles Hospital
Study Sponsor  ICMJE Versailles Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Versailles Hospital
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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