Genetic Susceptibility Factors for Candidemia.

NCT02841501 | Completed

• 2 other identifiers: 2011_632012-A01344-39
• Study Type: observational
• Target: 453
• Locations: 1 country
• Sites: 1

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.

Conditions

Invasive Candidiasis; Candidemia; Genetic Predisposition to Disease

Keywords

Gene Expression Profiling; Genome-Wide Association Study; Polymorphism, Single Nucleotide; Drug Resistance, Fungal

Outcome Measures

Primary Outcomes (1)

• Frequency of the polymorphisms between the groups

  In the 48-72 hours following the positive blood culture

Study Arms (2)

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

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

Interventions

Analysis of genetic polymorphisms GENETIC

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.

Candidemia patients; Control patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Lille: lead
• Seventh Framework Programme: collaborator
• University of Lausanne Hospitals: collaborator

Study Sites (1)

Hôpital Salengro, Intensive care departement, CHRU

Lille, France

Location

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.

MeSH Terms

Conditions

Candidiasis, Invasive; Candidemia; Genetic Predisposition to Disease

Condition Hierarchy (Ancestors)

Candidiasis; Mycoses; Bacterial Infections and Mycoses; Infections; Invasive Fungal Infections; Fungemia; Sepsis; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease Susceptibility; Disease Attributes

Study Officials

• Julien Poissy, MD, PhD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2016
• First Posted: July 22, 2016
• Study Start: June 1, 2013
• Primary Completion: June 25, 2020
• Study Completion: June 25, 2020
• Last Updated: March 26, 2021

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)