Analysis of Immune Response In Bacterial Infection of Obese Subject

Not Applicable

Completed

• Conditions: Obesity
• Interventions: Biological: blood analysis

• Registration Number: NCT02882568
• Lead Sponsor: Versailles Hospital

Brief Summary

Improve knowledge of the immune response to sepsis in obese patients. Define immunological and genetic prognostic factors of severe infections which can motivate a change in the therapeutic attitude

Detailed Description

Not available

Study Timeline

• Study Start: 2014-08
• Primary Completion: 2016-02
• Study First Submitted: 2016-06-14
• Study First Submitted QC: 2016-08-24
• Study First Posted: 2016-08-30
• Study Completion: 2016-09
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-19
• Last Update Posted: 2017-12-21

Recruitment & Eligibility

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

Inclusion Criteria

• between18 and 80 years

• obesity: BMI > 30

• presumed bacterial infection:

  • pneumonitis (documented or probably)
  • pyelonephritis / acute prostatitis
  • soft tissue / skin infection (except for bedsore)
  • cholecystitis / angiocholitis
  • meningitis
  • clostridium colitis
  • surgical site infection

• signed consent

Exclusion Criteria

• patients with viral, parasitic or mycotic documented infection
• patients with bacterial infection with treatment> 4 weeks (ex. endocarditis; osteo- articular infections)
• patients with prior antibiotic treatment (< 14 days)
• intensive care unit patients
• patients with a history of cancer or malignant hematological disease within the 5 previous years that is currently clinically significant (non metastatic prostatic and basocellular malignancy are excluded)
• patients with systemic disease
• Known diagnosis of human immunodeficiency infection (DICV, HIV...)
• immunosuppression treatment during last month including corticotherapy
• pregnancy
• 3 months follow up not possible
• non signed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
investigational	blood analysis	Blood test for Inflammatory and immunological analysis during acute sepsis phase and one month later

Primary Outcome Measures

Name	Time	Method
Patterns of inflammatory and immunological markers in obese patients in sepsis and post- sepsis ("normal") situation	T 0 and at 1 month	Standard inflammatory markers; immunological markers (cytokines, leptine, lymphocyte phenotype)

Secondary Outcome Measures

Name	Time	Method
Analysis of leptine polymorphism	1 month
Evaluation of sepsis; correlation with inflammatory and immunological parameters	T 0 and at 1 month

Trial Locations

Locations (1)

Ch de Versailles; 🇫🇷 Le Chesnay, France