NCT01482988

Brief Summary

The principal aim of this study is to establish if a polymorphism in a gene important for innate immunity to fungi represents a significant risk factor for the development of Candida colonisation and subsequent invasive candidosis in critically ill patients. Incorporation of a screening programme onto a risk-based algorithm for critical care patients would allow more effective targeting of molecular diagnostic tests, anti-fungal prophylaxis and targeted treatment. Sequential critical care patients will be screened for gene polymorphisms and undergo regular screening for Candida colonization.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
600

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

November 29, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 1, 2011

Completed
Same day until next milestone

Study Start

First participant enrolled

December 1, 2011

Completed
Last Updated

December 1, 2011

Status Verified

November 1, 2011

First QC Date

November 29, 2011

Last Update Submit

November 30, 2011

Conditions

Keywords

prevalence of the Dectin-1 polymorphism (Tyr238X)

Study Arms (1)

Critical care patients antipated to stay more than 72 hours

Eligibility Criteria

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

Critical care patients predicted to stay more than 72 hours

You may qualify if:

  • Patients aged \> 18 years
  • Patients with anticipated or actual critical care unit stay \> 72 hours
  • Consent or assent (if patient lacks capacity) obtained

You may not qualify if:

  • Age \< 18 years
  • Length of predicted stay on critical care \< 72 hours consent or assent not obtained

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Critical Care Unit

University Hospital of Wales, Cardiff, CF14 4XW, United Kingdom

Location

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Rosemary Barnes

    Cardiff University

    PRINCIPAL INVESTIGATOR
  • Matt P Wise

    Cardiff and Vale Local Health Board

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Critical Care Consultant

Study Record Dates

First Submitted

November 29, 2011

First Posted

December 1, 2011

Study Start

December 1, 2011

Last Updated

December 1, 2011

Record last verified: 2011-11

Locations