Analysis of Immune Response In Bacterial Infection of Obese Subject

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02882568

Acronym

ARIIBO

Enrollment

Registered

2016-08-30

Start date

2014-08-31

Completion date

2016-09-30

Last updated

2017-12-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

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

Interventions

BIOLOGICALblood 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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026