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Completed

NCT Number: NCT02882568

Analysis of Immune Response In Bacterial Infection of Obese Subject

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

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ch de Versailles

Le Chesnay, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

blood analysis

Biological

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

  1. 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

  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

Sponsors and collaborators

Lead sponsor

Versailles Hospital

Other

Registry information

Acronym: ARIIBO

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Aug 30, 2016
Registry last updated
Dec 21, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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