Analysis of Immune Response In Bacterial Infection of Obe... | NCT02882568

Studies
Analysis of Immune Response In Bacterial Infection of Obese Subject

NCT02882568

Sponsor

Versailles Hospital

Status

Completed

Last Update Posted

Dec 21, 2017Actual

Enrollment

15Actual

Phase

Not Applicable

Conditions

Obesity

Interventions

blood analysis

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2014

Primary Completion Date

Feb 2016Actual

Completion Date

Sep 2016Actual

First Submitted Date

Jun 14, 2016

First Submission Date that Met QC Criteria

Aug 24, 2016

First Posted Date

Aug 30, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 19, 2017

Last Update Posted Date

Dec 21, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

15Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
investigational	Other	Blood test for Inflammatory and immunological analysis during acute sepsis phase and one month later	Biological: blood analysis

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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)	T 0 and at 1 month

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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
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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D009765	Obesity

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases

Intervention Browse Module

MeSH Terms

ID	Term
D006403	Hematologic Tests

Ancestor Terms

ID	Term
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis
D008919	Investigative Techniques

Browse Leaves

Not provided

Browse Branches

Not provided