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Genetic Susceptibility Factors for Candidemia.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02841501
Recruitment Status : Active, not recruiting
First Posted : July 22, 2016
Last Update Posted : August 20, 2020
Sponsor:
Collaborators:
Seventh Framework Programme
University of Lausanne Hospitals
Information provided by (Responsible Party):
University Hospital, Lille

Brief Summary:
This is a prospective case-control physiopathological study, which main objective is to determine the genetic host factors predisposing to candidemia. Secondary objectives are to develop new diagnosis tools using the biological collection, to describe and update epidemiology, to analyse the influence of genetic polymorphisms on prognosis.

Condition or disease Intervention/treatment
Invasive Candidiasis Candidemia Genetic Predisposition to Disease Genetic: Analysis of genetic polymorphisms

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Study Type : Observational
Estimated Enrollment : 750 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Genetic Susceptibility Factors Involved in Candidemia: Case-control Study.
Study Start Date : June 2013
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Candidemia patients
These patients are included in the study after the reception of a positive blood culture for Candida sp.
Genetic: Analysis of genetic polymorphisms
An analysis of the SNPs (single nucleotide polymorphism) of 25 candidate genes will be performed. This analysis will be completed by a genome wide association study.

Control patients

These patients are matched on case patients on the following criteria:

  • Age+/-5 years
  • length of hospitalisation
  • type of ward
  • type of surgery for surgical patients
  • IGS2 for intensive care patients
Genetic: Analysis of genetic polymorphisms
An analysis of the SNPs (single nucleotide polymorphism) of 25 candidate genes will be performed. This analysis will be completed by a genome wide association study.




Primary Outcome Measures :
  1. Frequency of the polymorphisms between the groups [ Time Frame: In the 48-72 hours following the positive blood culture ]

Biospecimen Retention:   Samples With DNA

20 mL of blood samples are collected at inclusion. 10 mL on EDTA tubes for the genetic analysis, and 1 mL on dry tube for biomarkers development.

Paxgen tubes will be collected in a sample of patients for a transcriptomic study.



Information from the National Library of Medicine

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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
Hospitalized patients exhibiting a positive blood culture with isolation of Candida sp.
Criteria

Inclusion Criteria:

  • Patient older than 18 years.
  • Informed consent.
  • Positive blood culture with isolation of Candida sp.

Exclusion Criteria:

  • No informed consent.
  • Patient younger than 18.
  • No insurance coverage.

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): NCT02841501


Locations
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France
Hôpital Salengro, Intensive care departement, CHRU
Lille, France
Sponsors and Collaborators
University Hospital, Lille
Seventh Framework Programme
University of Lausanne Hospitals
Investigators
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Principal Investigator: Julien Poissy, MD, PhD University Hospital, Lille
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Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT02841501    
Other Study ID Numbers: 2011_63
2012-A01344-39 ( Other Identifier: ID-RCB number, ANSM )
First Posted: July 22, 2016    Key Record Dates
Last Update Posted: August 20, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University Hospital, Lille:
Gene Expression Profiling
Genome-Wide Association Study
Polymorphism, Single Nucleotide
Drug Resistance, Fungal
Additional relevant MeSH terms:
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Candidiasis
Candidemia
Candidiasis, Invasive
Disease Susceptibility
Genetic Predisposition to Disease
Mycoses
Disease Attributes
Pathologic Processes
Fungemia
Sepsis
Infection
Invasive Fungal Infections
Systemic Inflammatory Response Syndrome
Inflammation