Analysis of Immune Response In Bacterial Infection of Obese Subject

NCT02882568 | Completed

• 1 other identifier: P15/19_ARIIBO
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Evaluation of sepsis; correlation with inflammatory and immunological parameters

  T 0 and at 1 month

• Analysis of leptine polymorphism

  1 month

Study Arms (1)

investigational

OTHER

Blood test for Inflammatory and immunological analysis during acute sepsis phase and one month later

Biological: blood analysis

Interventions

blood analysis BIOLOGICAL

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

investigational

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• months follow up not possible
• non signed consent

Sponsors & Collaborators

• Versailles Hospital: lead

Study Sites (1)

Ch de Versailles

Le Chesnay, France

Location

MeSH Terms

Conditions

Obesity

Interventions

Hematologic Tests

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: June 14, 2016
• First Posted: August 30, 2016
• Study Start: August 1, 2014
• Primary Completion: February 1, 2016
• Study Completion: September 1, 2016
• Last Updated: December 21, 2017

Record last verified: 2017-12

Locations

FR (1)