Alteration of the Immune Response in Bacterial Infection (ARIIBACT)
Primary Purpose
Infection
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
blood sample
Sponsored by
About this trial
This is an interventional basic science trial for Infection
Eligibility 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)
Sites / Locations
- CH Versailles
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Interventional arm
Arm Description
blood sample before, during and after treatment for infection
Outcomes
Primary Outcome Measures
cytokin analysis (IL-6, IL-10, IL-17, TNFα, IFNγ)
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)
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
Description of the genetic polymorphism of leptine and leptine receptor in non-obese subjects in comparison with this same profile in obese subjects
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03948308
Brief Title
Alteration of the Immune Response in Bacterial Infection
Acronym
ARIIBACT
Official Title
Alteration of the Immune Response in Bacterial Infection
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Unknown status
Study Start Date
May 1, 2019 (Anticipated)
Primary Completion Date
May 1, 2020 (Anticipated)
Study Completion Date
September 1, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Versailles Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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"
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infection
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Interventional arm
Arm Type
Experimental
Arm Description
blood sample before, during and after treatment for infection
Intervention Type
Biological
Intervention Name(s)
blood sample
Intervention Description
blood sample before, during and after infection treatment
Primary Outcome Measure Information:
Title
cytokin analysis (IL-6, IL-10, IL-17, TNFα, IFNγ)
Description
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
Time Frame
1 month
Title
adipokin analysis (leptine, adiponectine)
Description
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
Time Frame
1 month
Title
leptin polymorphism analysis
Description
Description of the genetic polymorphism of leptine and leptine receptor in non-obese subjects in comparison with this same profile in obese subjects
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Meckenstock
Phone
+331 39 63 93 19
Email
rmeckenstock@ch-versailles.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Laure Morisset
Phone
+33139239785
Email
lmorisset@ch-versailles.fr
Facility Information:
Facility Name
CH Versailles
City
Le Chesnay
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Meckenstock
12. IPD Sharing Statement
Plan to Share IPD
No
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Alteration of the Immune Response in Bacterial Infection
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