Alteration of the Immune Response in Bacterial Infection

Not Applicable

• Conditions: Infection
• Interventions: Biological: blood sample

• Registration Number: NCT03948308
• Lead Sponsor: Versailles Hospital

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 available

Study Timeline

• Study First Submitted: 2019-04-15
• Status Verified: 2019-05
• Study Start: 2019-05-01
• Study First Submitted QC: 2019-05-09
• Last Update Submitted: 2019-05-09
• Study First Posted: 2019-05-13
• Last Update Posted: 2019-05-13
• Primary Completion: 2020-05-01
• Study Completion: 2020-09-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 15

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Interventional arm	blood sample	blood sample before, during and after treatment for infection

Primary Outcome Measures

Name	Time	Method
cytokin analysis (IL-6, IL-10, IL-17, TNFα, IFNγ)	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	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)	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

Trial Locations

Locations (1)

CH Versailles; 🇫🇷 Le Chesnay, France