Analysis of Immune Response In Bacterial Infection of Obese Subject (ARIIBO)

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

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Biological: blood analysis

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

Contacts and Locations

Study Locations

• France
  • Le Chesnay, France
    • CH de Versailles

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:

• 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 Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: investigational; Blood test for Inflammatory and immunological analysis during acute sepsis phase and one month later	Biological: blood analysis; Pilot study, single center, interventional including 15 obese subjects with acute sepsis. Inflammatory and immunological tests during acute phase and one month later after a presumed return parameters at baseline

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
Evaluation of sepsis; correlation with inflammatory and immunological parameters	T 0 and at 1 month
Analysis of leptine polymorphism	1 month

Collaborators and Investigators

• Sponsor: Versailles Hospital

Study record dates

Study Major Dates

• Study Start: August 1, 2014
• Primary Completion (Actual): February 1, 2016
• Study Completion (Actual): September 1, 2016

Study Registration Dates

• First Submitted: June 14, 2016
• First Submitted That Met QC Criteria: August 24, 2016
• First Posted (Estimate): August 30, 2016

Study Record Updates

• Last Update Posted (Actual): December 21, 2017
• Last Update Submitted That Met QC Criteria: December 19, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Bacterial Infections and Mycoses; Bacterial Infections
• Other Study ID Numbers: P15/19_ARIIBO