Alteration of the Immune Response in Bacterial Infection (ARIIBACT)

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"

Study Overview

• Status: Unknown
• Conditions: Infection
• Intervention / Treatment: Biological: blood sample

• Study Type: Interventional
• Enrollment (Anticipated): 15
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Laure Morisset; Phone Number: +33139239785; Email: lmorisset@ch-versailles.fr
• Study Contact Backup: Name: Meckenstock; Phone Number: +331 39 63 93 19; Email: rmeckenstock@ch-versailles.fr

Study Locations

• France
  • Le Chesnay, France
    • CH Versailles
    • Contact: Meckenstock

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	1 month
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	1 month
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	1 month

Collaborators and Investigators

• Sponsor: Versailles Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2019
• Primary Completion (Anticipated): May 1, 2020
• Study Completion (Anticipated): September 1, 2020

Study Registration Dates

• First Submitted: April 15, 2019
• First Submitted That Met QC Criteria: May 9, 2019
• First Posted (Actual): May 13, 2019

Study Record Updates

• Last Update Posted (Actual): May 13, 2019
• Last Update Submitted That Met QC Criteria: May 9, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Bacterial Infections and Mycoses; Infections; Communicable Diseases; Bacterial Infections
• Other Study ID Numbers: P17/03_ARIIBACT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No