Genetic Susceptibility Factors for Candidemia.

• Sponsor: University Hospital, Lille (Other)
• Overall Status: Completed
• CT.gov ID: NCT02841501
• Collaborator: Seventh Framework Programme (Other), University of Lausanne Hospitals (Other)
• Enrollment: 453
• Location: 1
• Actual Duration (Months): 84.8
• Patients Per Site Per Month: 5.3

Study Details

Study Description

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	Phase
Invasive Candidiasis; Candidemia; Genetic Predisposition to Disease	Genetic: Analysis of genetic polymorphisms

Study Design

• Study Type: Observational
• Actual Enrollment: 453 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Genetic Susceptibility Factors Involved in Candidemia: Case-control Study.
• Actual Study Start Date: Jun 1, 2013
• Actual Primary Completion Date: Jun 25, 2020
• Actual Study Completion Date: Jun 25, 2020

Arms and Interventions

Arm	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.

Outcome Measures

Primary Outcome Measures

1. Frequency of the polymorphisms between the groups [In the 48-72 hours following the positive blood culture]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hôpital Salengro, Intensive care departement, CHRU	Lille		France

Sponsors and Collaborators

• University Hospital, Lille
• Seventh Framework Programme
• University of Lausanne Hospitals

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospital, Lille
• ClinicalTrials.gov Identifier: NCT02841501
• Other Study ID Numbers: 2011_63; 2012-A01344-39
• First Posted: Jul 22, 2016
• Last Update Posted: Mar 26, 2021
• Last Verified: Aug 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• 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: Candidiasis; Candidemia; Candidiasis, Invasive; Disease Susceptibility; Genetic Predisposition to Disease

Study Results

No Results Posted as of Mar 26, 2021