Back to resultsAnalysis of Immune Response In Bacterial Infection of Obese Subject (ARIIBO)
Primary Purpose
Obesity
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
blood analysis
Sponsored by
About this trial
This is an interventional supportive care trial for Obesity
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
Sites / Locations
- Ch de Versailles
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
investigational
Arm Description
Blood test for Inflammatory and immunological analysis during acute sepsis phase and one month later
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Evaluation of sepsis; correlation with inflammatory and immunological parameters
Analysis of leptine polymorphism
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02882568
Brief Title
Analysis of Immune Response In Bacterial Infection of Obese Subject
Acronym
ARIIBO
Official Title
Analysis of Immune Response In Bacterial Infection of Obese Subject
Study Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
August 2014 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
September 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Versailles Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
investigational
Arm Type
Other
Arm Description
Blood test for Inflammatory and immunological analysis during acute sepsis phase and one month later
Intervention Type
Biological
Intervention Name(s)
blood analysis
Intervention Description
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 Outcome Measure Information:
Title
Patterns of inflammatory and immunological markers in obese patients in sepsis and post- sepsis ("normal") situation
Description
Standard inflammatory markers; immunological markers (cytokines, leptine, lymphocyte phenotype)
Time Frame
T 0 and at 1 month
Secondary Outcome Measure Information:
Title
Evaluation of sepsis; correlation with inflammatory and immunological parameters
Time Frame
T 0 and at 1 month
Title
Analysis of leptine polymorphism
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Ch de Versailles
City
Le Chesnay
Country
France
12. IPD Sharing Statement
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Analysis of Immune Response In Bacterial Infection of Obese Subject
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