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Clinical Trials/NCT02882568
NCT02882568
Completed
Not Applicable

Analysis of Immune Response In Bacterial Infection of Obese Subject

Versailles Hospital1 site in 1 country15 target enrollmentAugust 2014
ConditionsObesity

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Obesity
Sponsor
Versailles Hospital
Enrollment
15
Locations
1
Primary Endpoint
Patterns of inflammatory and immunological markers in obese patients in sepsis and post- sepsis ("normal") situation
Status
Completed
Last Updated
8 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
August 2014
End Date
September 2016
Last Updated
8 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Versailles Hospital
Responsible Party
Principal Investigator
Principal Investigator

Roderick Meckenstock

Dr

Versailles Hospital

Eligibility Criteria

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

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

Outcomes

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

Standard inflammatory markers; immunological markers (cytokines, leptine, lymphocyte phenotype)

Secondary Outcomes

  • Analysis of leptine polymorphism(1 month)
  • Evaluation of sepsis; correlation with inflammatory and immunological parameters(T 0 and at 1 month)

Study Sites (1)

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