NCT01919931

Brief Summary

Candida albicans is one of the most common nosocomial infection and the onset relies on the host immune status. The purpose of this study is to determine the immunological profile of patients infected with Candida albicans, that could ideally lead to a strategy to identify patients who could benefit from prophylaxis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
237

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2013

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 19, 2013

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 9, 2013

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

December 7, 2016

Status Verified

December 1, 2016

Enrollment Period

2.4 years

First QC Date

June 19, 2013

Last Update Submit

December 6, 2016

Conditions

Candidiasis

Keywords

Candida albicansCandidiasisBiofilmFlow cytometryMannose Binding Lectin

Outcome Measures

Primary Outcomes (1)

  • Immunological phenotyping of patients

    2 months

Secondary Outcomes (1)

  • Mannose Binding Lectin levels

    1 month

Study Arms (2)

Candida Infection

Patients infected with Candida albicans

No infection

Patients with no Candida albicans infection

Eligibility Criteria

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

Patients with Candida albicans infection. Patients with no Candida albicans infection. Healthy volunteers

You may qualify if:

  • Patients infected with Candida albicans
  • Patients not infected with Candida albicans

You may not qualify if:

  • Underage patients
  • Non consenting patients
  • Unconscious patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitair Ziekenhuis Leuven

Leuven, Flemish Brabant, 3000, Belgium

Location

Biospecimen

Retention: NONE RETAINED

Samples to be retained: whole blood, Plasma and White cells.

MeSH Terms

Conditions

Candidiasis

Condition Hierarchy (Ancestors)

MycosesBacterial Infections and MycosesInfections

Study Officials

  • Adrian Liston, Group Leader

    Flemish Institute of Biotechnology

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 19, 2013

First Posted

August 9, 2013

Study Start

March 1, 2013

Primary Completion

August 1, 2015

Study Completion

January 1, 2016

Last Updated

December 7, 2016

Record last verified: 2016-12

Locations

BE(1)