Analysis of Immune Response In Bacterial Infection of Obese Subject

Obesity Clinical Trial

— ARIIBO  

Official title:

Analysis of Immune Response In Bacterial Infection of Obese Subject

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02882568
• Other study ID #: P15/19_ARIIBO
• Status: Completed
• Phase: N/A
• First received: June 14, 2016
• Last updated: December 19, 2017
• Start date: August 2014
• Est. completion date: September 2016

Study information

• Verified date: December 2017
• Source: Versailles Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: September 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Bacterial Infections
• Obesity

Intervention

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

Locations

Country	Name	City	State
France	Ch de Versailles	Le Chesnay

Sponsors (1)

Lead Sponsor	Collaborator
Versailles Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Evaluation of sepsis; correlation with inflammatory and immunological parameters		T 0 and at 1 month
Secondary	Analysis of leptine polymorphism		1 month