Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Alteration of the Immune Response in Bacterial Infection (ARIIBACT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03948308
Recruitment Status : Not yet recruiting
First Posted : May 13, 2019
Last Update Posted : May 13, 2019
Sponsor:
Information provided by (Responsible Party):
Roderick Meckenstock, 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"


Condition or disease Intervention/treatment Phase
Infection Biological: blood sample Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Alteration of the Immune Response in Bacterial Infection
Estimated Study Start Date : May 1, 2019
Estimated Primary Completion Date : May 1, 2020
Estimated Study Completion Date : September 1, 2020

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03948308


Contacts
Layout table for location contacts
Contact: Meckenstock +331 39 63 93 19 rmeckenstock@ch-versailles.fr
Contact: Laure Morisset +33139239785 lmorisset@ch-versailles.fr

Locations
Layout table for location information
France
CH Versailles
Le Chesnay, France
Contact: Meckenstock         
Sponsors and Collaborators
Versailles Hospital
Layout table for additonal information
Responsible Party: Roderick Meckenstock, Principal Investigator, Versailles Hospital
ClinicalTrials.gov Identifier: NCT03948308    
Other Study ID Numbers: P17/03_ARIIBACT
First Posted: May 13, 2019    Key Record Dates
Last Update Posted: May 13, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Infection
Communicable Diseases
Bacterial Infections