Analysis of Immune Response In Bacterial Infection of Obese Subject

NCT ID: NCT02882568

Last Updated: 2017-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2016-09-30

Brief Summary

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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

Detailed Description

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Conditions

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Obesity

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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investigational

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

Group Type OTHER

blood analysis

Intervention Type 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

Interventions

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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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Versailles Hospital

OTHER

Sponsor Role lead

Responsible Party

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Roderick Meckenstock

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ch de Versailles

Le Chesnay, , France

Site Status

Countries

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France

Other Identifiers

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P15/19_ARIIBO

Identifier Type: -

Identifier Source: org_study_id