Genetic Susceptibility Factors for Candidemia.

March 25, 2021 updated by: University Hospital, Lille

Genetic Susceptibility Factors Involved in Candidemia: Case-control Study.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

453

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lille, France
        • Hôpital Salengro, Intensive care departement, CHRU

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Frequency of the polymorphisms between the groups
Time Frame: In the 48-72 hours following the positive blood culture
In the 48-72 hours following the positive blood culture

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Lille

Collaborators

University of Lausanne Hospitals
Seventh Framework Programme

Investigators

  • Principal Investigator: Julien Poissy, MD, PhD, University Hospital, Lille

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 1, 2013

Primary Completion (ACTUAL)

June 25, 2020

Study Completion (ACTUAL)

June 25, 2020

Study Registration Dates

First Submitted

July 20, 2016

First Submitted That Met QC Criteria

July 20, 2016

First Posted (ESTIMATE)

July 22, 2016

Study Record Updates

Last Update Posted (ACTUAL)

March 26, 2021

Last Update Submitted That Met QC Criteria

March 25, 2021

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011_63
  • 2012-A01344-39 (OTHER: ID-RCB number, ANSM)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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