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Trial record 39 of 228 for:    yeast

Innate Immunity Gene Polymorphisms and Yeast Colonization (Candigene)

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ClinicalTrials.gov Identifier: NCT02888860
Recruitment Status : Recruiting
First Posted : September 5, 2016
Last Update Posted : February 20, 2019
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by (Responsible Party):
University Hospital, Lille

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-1,3 glucan).

Condition or disease
Critical Illness

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 -80°C. 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.


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 2200 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 15 Days
Official Title: Analysis of TLRs and Lectin Gene Polymorphisms. Impact on Yeast Colonization in Hospitalized Patients and on Adaptive Response Against Yeast Glycans
Actual Study Start Date : January 3, 2013
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine


Group/Cohort
Group 1
Patients with candidemia
Group 2
Patients without colonization during follow up
Group 3
Patients without colonization at admission, with subsequent colonization during hospitalization
Group
Patients colonized at admission, and during the whole hospitalization
Group 5
Patients who develop colonization during hospitalization and become negative at discharge



Primary Outcome Measures :
  1. Frequency of polymorphisms [ Time Frame: From date of inclusion until the last day hospital stay (at once a week) ]

    the frequency is measured for the association between the presence of a polymorphism and colonization by Candida sp.

    frequency of polymorphisms at least one lectin gene or TLRs between some colonized patients (G5) and the non-colonized patients (G2).



Secondary Outcome Measures :
  1. Genotyping of lectin genes and toll-like-receptors (TLRs) [ Time Frame: From date of inclusion until the last day hospital stay (at once a week) ]
    The analysis relates to genetic factors already described for lectins and will also include variants of genes involved in innate immunity host-microorganism interactions such as TLRs

  2. Colonization index [ Time Frame: at admission and weekly for at least two weeks after. ]

    This index is calculated for each patient at the entrance of the service and then once a week until discharge (at least two weeks after admission). This index is the ratio between the number of body sites colonized heavily on the number of body sites explored when at least one colony of Candida spp. was observed.

    The determination of Candida colonization index requires the implementation of several samples from different body sites. The sampled anatomical sites concern

    1. mouth (oropharyngeal swab)
    2. stomach (gastric aspiration)
    3. trachea (tracheal suctioning)
    4. urine
    5. rectum (rectal swab or stool).

  3. Functional tests on peripheral blood mononuclear cells (PBMC) [ Time Frame: at admission and weekly for at least two weeks after. ]
    Functional tests on peripheral blood mononuclear cells (PBMC) obtained from mutated patients for given Innate-immunity genes will be carried out through stimulation tests in the presence of whole yeast or derived-molecules on isolated cell subpopulations.


Biospecimen Retention:   Samples With DNA
whole blood, serum, yeast strains, PBMCs


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Critically ill patients
Criteria

Inclusion Criteria:

  • Male or female patients, ≥18 years of age, admitted to medical or surgical ICU for a duration of >48 h, irrespective of their colonisation status.

Exclusion Criteria:

  • -Patient (or their representative) who refuses to participate in the study or to undergo the procedures required for the investigations (mycological sampling in order to determine the CIC, blood sampling for genotyping of DNA and for serology)
  • Previous antifungal treatment (in the 15 days preceding admission to the ICU).
  • A CIC value based on an insufficient number of sampled sites (<6).
  • Neutropenic patients
  • Patients who are receiving immunosuppressants (transplanted, grafted...)
  • Patients who do not have universal cover or Social Security cover

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02888860


Contacts
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Contact: Daniel Mathieu, Prof 33320444495 bsendid@univ-lille2.fr
Contact: Boualem Sendid 333204455117 boualem.sendid@chru-lille.fr

Locations
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France
CHRU de Lille Recruiting
Lille, Nord, France, 59037
Contact: Daniel Mathieu, Prof    33320444495    bsendid@univ-lille2.fr   
Contact: Boualem Sendid, Prof    33320445577    boualem.sendid@chru-lille.fr   
Sub-Investigator: Saad Nseir, Dr         
Centre hospitalier Not yet recruiting
Arras, France
Contact: Didier Thevenin, MD         
Principal Investigator: Didier Thevenin, MD         
Centre hosptialier Not yet recruiting
Boulogne-sur-Mer, France
Contact: Brunin, MD         
Principal Investigator: Brunin, MD         
CH Schaffner Not yet recruiting
Lens, France
Contact: Didier Thevenin, MD         
Principal Investigator: Didier Thevenin, MD         
Hôpital Saint-Philibert Not yet recruiting
Lomme, France
Contact: Van Der Linden, MD         
Principal Investigator: Van Der Linden, MD         
CH Victor Provo Not yet recruiting
Roubaix, France
Contact: Nuyenga Makenga, MD         
Principal Investigator: Nuyenga Makenga, MD         
Sponsors and Collaborators
University Hospital, Lille
Ministry of Health, France
Investigators
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Principal Investigator: Daniel Mathieu, Prof CHRU de Lille

Additional Information:

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Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT02888860     History of Changes
Other Study ID Numbers: 2011_33
2011_33 ( Other Grant/Funding Number: French Ministry of Health PHRC national 2011 )
2012-A00485-38 ( Other Identifier: ID-RCB number, ANSM )
First Posted: September 5, 2016    Key Record Dates
Last Update Posted: February 20, 2019
Last Verified: February 2019
Keywords provided by University Hospital, Lille:
genetic susceptibility
candida infection
colonization
Additional relevant MeSH terms:
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Critical Illness
Disease Attributes
Pathologic Processes