Immunological Interaction Between the Host and Candida Al... | NCT01919931

Studies
Immunological Interaction Between the Host and Candida Albicans Biofilm

NCT01919931

Sponsor

Universitaire Ziekenhuizen KU Leuven

Status

Completed

Last Update Posted

Dec 7, 2016Estimated

Enrollment

237Actual

Phase

Not provided

Conditions

Candidiasis

Interventions

Not provided

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2013

Primary Completion Date

Aug 2015Actual

Completion Date

Jan 2016Actual

First Submitted Date

Jun 19, 2013

First Submission Date that Met QC Criteria

Aug 6, 2013

First Posted Date

Aug 9, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 6, 2016

Last Update Posted Date

Dec 7, 2016Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

237Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Candida Infection		Patients infected with Candida albicans
No infection		Patients with no Candida albicans infection

Interventions

Not provided

Measure	Description	Time Frame
Immunological phenotyping of patients		2 months

Measure	Description	Time Frame
Mannose Binding Lectin levels		1 month

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients infected with Candida albicans
Patients not infected with Candida albicans

Exclusion Criteria:

Underage patients
Non consenting patients
Unconscious patients

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Adrian Liston, Group Leader	Flemish Institute of Biotechnology	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Universitair Ziekenhuis Leuven		Leuven	Flemish Brabant	3000	Belgium

Condition Browse Module

MeSH Terms

ID	Term
D002177	Candidiasis

Ancestor Terms

ID	Term
D009181	Mycoses
D001423	Bacterial Infections and Mycoses
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided