Alteration of the Immune Response in Bacterial Infection

Infection Clinical Trial

— ARIIBACT  

Official title:

Alteration of the Immune Response in Bacterial Infection

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03948308
• Other study ID #: P17/03_ARIIBACT
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2019
• Est. completion date: September 1, 2020

Study information

• Verified date: May 2019
• Source: Versailles Hospital
• Contact: Meckenstock
• Phone: +331 39 63 93 19
• Email: rmeckenstock[@]ch-versailles.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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"

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 15
• Est. completion date: September 1, 2020
• Est. primary completion date: May 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Bacterial Infections
• Communicable Diseases
• Infection

Intervention

Biological:
• blood sample
blood sample before, during and after infection treatment

Locations

Country	Name	City	State
France	CH Versailles	Le Chesnay

Sponsors (1)

Lead Sponsor	Collaborator
Versailles Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cytokin analysis (IL-6, IL-10, IL-17, TNFa, IFN?)	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
Primary	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
Primary	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