NCT03948308

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"

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 15, 2019

Completed
16 days until next milestone

Study Start

First participant enrolled

May 1, 2019

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 13, 2019

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2020

Completed
Last Updated

May 13, 2019

Status Verified

May 1, 2019

Enrollment Period

1 year

First QC Date

April 15, 2019

Last Update Submit

May 9, 2019

Conditions

Infection

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (1)

Interventional arm

EXPERIMENTAL

blood sample before, during and after treatment for infection

Biological: blood sample

Interventions

blood sampleBIOLOGICAL

blood sample before, during and after infection treatment

Interventional arm

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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 ...)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CH Versailles

Le Chesnay, France

Location

MeSH Terms

Conditions

Infections

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Central Study Contacts

Meckenstock

CONTACT

+331 39 63 93 19rmeckenstock@ch-versailles.fr

Laure Morisset

CONTACT

+33139239785lmorisset@ch-versailles.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 15, 2019

First Posted

May 13, 2019

Study Start

May 1, 2019

Primary Completion

May 1, 2020

Study Completion

September 1, 2020

Last Updated

May 13, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)