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Clinical Trials/NCT03948308
NCT03948308
Unknown
Not Applicable

Alteration of the Immune Response in Bacterial Infection

Versailles Hospital1 site in 1 country15 target enrollmentMay 1, 2019
ConditionsInfection

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Infection
Sponsor
Versailles Hospital
Enrollment
15
Locations
1
Primary Endpoint
cytokin analysis (IL-6, IL-10, IL-17, TNFα, IFNγ)
Last Updated
6 years ago

Overview

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"

Registry
clinicaltrials.gov
Start Date
May 1, 2019
End Date
September 1, 2020
Last Updated
6 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Versailles Hospital
Responsible Party
Principal Investigator
Principal Investigator

Roderick Meckenstock

Principal Investigator

Versailles Hospital

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)

Outcomes

Primary Outcomes

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

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

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

Study Sites (1)

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