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CompletedNCT02882568ARIIBOUpdated Dec 21, 2017

Analysis of Immune Response In Bacterial Infection of Obese Subject

An interventional study of blood analysis in Obesity, sponsored by Versailles Hospital. Completed at 1 site in France. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2017-12-21.

Sponsored by Versailles Hospital · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
15
Allocation
Not applicable
Ages
18 Years to 80 Years
Sex
All
01

Study 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

02

Conditions studied

  • Obesity

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03

In context

Bacterial Infections

658 studies on the registry are indexed under Bacterial Infections; 100 are open to participants now.

This study's enrollment of 15 is below the median of 84 across 405 interventional studies indexed under Bacterial Infections.

Browse Bacterial Infections studies →

Lead sponsor

Versailles Hospital is the lead sponsor of 74 studies on the registry; 17 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
15 participants (actual)

Study arms

  • Other
    investigational

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

    Biological: blood analysis

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

06

What researchers measure

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)

    Time frame: T 0 and at 1 month

Secondary outcomes

  1. Evaluation of sepsis; correlation with inflammatory and immunological parameters

    Time frame: T 0 and at 1 month

  2. Analysis of leptine polymorphism

    Time frame: 1 month

07

Study locations

1 site
  • Ch de Versailles
    Le Chesnay, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 21, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02882568
Lead sponsor
Versailles Hospital
Responsible party
Roderick Meckenstock (Dr, Versailles Hospital) — Principal investigator
First posted
Aug 30, 2016
Start date
Aug 2014
Primary completion
Feb 2016
Completion
Sep 2016
Last update
Dec 21, 2017

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.

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