Ignite Creation Date:
2024-05-06 @ 9:01 AM
Last Modification Date:
2024-10-26 @ 12:09 PM
Study NCT ID:
NCT02888860
Status:
COMPLETED
Last Update Posted:
2022-11-04
First Post:
2014-02-28
Brief Title:
Innate Immunity Gene Polymorphisms and Yeast Colonization
Sponsor:
University Hospital Lille
Organization:
University Hospital Lille
Study Overview
Official Title:
Analysis of TLRs and Lectin Gene Polymorphisms Impact on Yeast Colonization in Hospitalized Patients and on Adaptive Response Against Yeast Glycans
Status:
COMPLETED
Status Verified Date:
2020-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Candigene
Brief Summary:
It is proposed to carry out the study in three medical or surgical intensive care units ICU in the CHRU Lille and the CHU Besançon In all patients admitted to these ICU see Figure 2 a corrected index of colonisation CIC will be determined and blood samples will be taken for genotyping of the lectins MBL Dectin-1 and Galectin-3 and for serology Over the duration of hospitalisation on average 28 days and weekly fungal colonisation will be assessed in all patients according to the CIC and antibodies to yeast glycans will be determined by a simultaneous multiparametric analysis involving several families of natural or synthetic antigens and the detection of circulating antigens mannan and β-13 glucan
Detailed Description:
Determination of the CIC
The CIC will be determined on admission and then once a week during hospitalisation This will be carried out on a fixed day for all patients we will avoid determining the CIC any closer than 2 days apart It is not planned in this study to modify the therapeutic strategy of the ICU services The strains isolated will be stored in glycerol solution at -80C The specimens for genetic and serological analysis will be stored centrally in a local mycology laboratory
Genotyping of lectin genes and TLRs
Two tubes containing 6 ml of blood in EDTA will be taken from each patient for extraction of DNA
Serological study detection of antibodies to yeast glycans
10 ml of whole blood will be taken from each patient on the day of inclusion and over the duration of hospitalisation maximum total quantity of 40 ml This will be done on a fixed day for all patients we will avoid sampling any closer than 2 days apart
Functional tests on peripheral blood mononuclear cells PBMCs Taking into account the fact that the results of genotyping will not be available in real time and the need to work with freshly collected cells a group size of 50 patients in group 2 negative CIC over the duration of hospitalisation and 50 patients in group 3 negative CIC at admission but positive at hospital discharge will be analysed
Stimulation tests will be carried out in the presence of whole yeasts or yeast extracts on sub-populations of cells isolated from 20 ml of peripheral blood in EDTA
The CIC will be determined on admission and then once a week during hospitalisation This will be carried out on a fixed day for all patients we will avoid determining the CIC any closer than 2 days apart It is not planned in this study to modify the therapeutic strategy of the ICU services The strains isolated will be stored in glycerol solution at -80C The specimens for genetic and serological analysis will be stored centrally in a local mycology laboratory
Genotyping of lectin genes and TLRs
Two tubes containing 6 ml of blood in EDTA will be taken from each patient for extraction of DNA
Serological study detection of antibodies to yeast glycans
10 ml of whole blood will be taken from each patient on the day of inclusion and over the duration of hospitalisation maximum total quantity of 40 ml This will be done on a fixed day for all patients we will avoid sampling any closer than 2 days apart
Functional tests on peripheral blood mononuclear cells PBMCs Taking into account the fact that the results of genotyping will not be available in real time and the need to work with freshly collected cells a group size of 50 patients in group 2 negative CIC over the duration of hospitalisation and 50 patients in group 3 negative CIC at admission but positive at hospital discharge will be analysed
Stimulation tests will be carried out in the presence of whole yeasts or yeast extracts on sub-populations of cells isolated from 20 ml of peripheral blood in EDTA
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2012-A00485-38 | OTHER | ID-RCB number ANSM | None |
| 2011_33 | OTHER_GRANT | None | None |