NCT02888860

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2013

Longer than P75 for all trials

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 3, 2013

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

February 28, 2014

Completed
2.5 years until next milestone

First Posted

Study publicly available on registry

September 5, 2016

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 3, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 3, 2021

Completed
Last Updated

November 4, 2022

Status Verified

August 1, 2020

Enrollment Period

8 years

First QC Date

February 28, 2014

Last Update Submit

November 3, 2022

Conditions

Critical Illness

Keywords

genetic susceptibilitycandida infectioncolonization

Outcome Measures

Primary Outcomes (1)

  • Frequency of polymorphisms

    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).

    From date of inclusion until the last day hospital stay (at once a week)

Secondary Outcomes (3)

  • Genotyping of lectin genes and toll-like-receptors (TLRs)

    From date of inclusion until the last day hospital stay (at once a week)

  • Colonization index

    at admission and weekly for at least two weeks after.

  • Functional tests on peripheral blood mononuclear cells (PBMC)

    at admission and weekly for at least two weeks after.

Study Arms (5)

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Critically ill patients

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

CHRU de Lille

Lille, Nord, 59037, France

Location

Centre hospitalier

Arras, France

Location

Centre hosptialier

Boulogne-sur-Mer, France

Location

CH Schaffner

Lens, France

Location

Hôpital Saint-Philibert

Lomme, France

Location

CH Victor Provo

Roubaix, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

whole blood, serum, yeast strains, PBMCs

MeSH Terms

Conditions

Critical IllnessGenetic Predisposition to DiseaseCandidiasis

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsDisease SusceptibilityMycosesBacterial Infections and MycosesInfections

Study Officials

  • Daniel Mathieu, Prof

    CHRU de Lille

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
15 Days
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 28, 2014

First Posted

September 5, 2016

Study Start

January 3, 2013

Primary Completion

January 3, 2021

Study Completion

January 3, 2021

Last Updated

November 4, 2022

Record last verified: 2020-08

Locations

FR(6)