This trial is active, not recruiting.

Condition obesity
Treatment blood analysis
Sponsor Central Hospital, Versailles
Start date August 2014
End date February 2016
Trial size 15 participants
Trial identifier NCT02882568, P15/19_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

United States No locations recruiting
Other countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose supportive care
Blood test for Inflammatory and immunological analysis during acute sepsis phase and one month later
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

Primary Outcomes

Patterns of inflammatory and immunological markers in obese patients in sepsis and post- sepsis ("normal") situation
time frame: T 0 and at 1 month

Secondary Outcomes

Evaluation of sepsis; correlation with inflammatory and immunological parameters
time frame: T 0 and at 1 month
Analysis of leptine polymorphism
time frame: 1 month

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

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

Additional Information

Official title Analysis of Immune Response In Bacterial Infection of Obese Subject
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Central Hospital, Versailles.