Evaluation of Exhaled Breath Condensate in the Diagnosis... | NCT01247142

Studies
Evaluation of Exhaled Breath Condensate in the Diagnosis of Invasive Pulmonary Aspergillosis

NCT01247142

Sponsor

Universitaire Ziekenhuizen KU Leuven

Status

Completed

Last Update Posted

Jul 8, 2014Estimated

Enrollment

24Actual

Phase

Not provided

Conditions

Invasive Pulmonary Aspergillosis

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

Jul 2014

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

Jan 2011

Primary Completion Date

Jul 2014Actual

Completion Date

Jul 2014Actual

First Submitted Date

Nov 23, 2010

First Submission Date that Met QC Criteria

Nov 23, 2010

First Posted Date

Nov 24, 2010Estimated

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

Jul 4, 2014

Last Update Posted Date

Jul 8, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Edith Vermeulen, PhD fellow, Universitaire Ziekenhuizen KU LeuvenPrincipal Investigator

Lead Sponsor

Universitaire Ziekenhuizen KU LeuvenOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to evaluate the diagnostic potential of biomarkers for invasive pulmonary aspergillosis in exhaled breath condensate.

Detailed Description

Invasive pulmonary aspergillosis (IPA) is a life-threatening infection in immunocompromised patients. The poor prognosis of the disease is partly attributed to difficulties encountered with the diagnosis of this infection. Invasive sampling procedures are often precluded in these patients. In addition, conventional diagnostic techniques lack sensitivity. Recently there has been increasing interest in the investigation of the lungs by noninvasive means including measurement of biomarkers in exhaled breath (e.g. NO) and those found in the cooled and condensed exhalate,termed EBC. It has been demonstrated that a measurable fraction of the EBC in healthy subjects is derived from aerosolized airway lining fluid. The presence of biomarkers for IPA will be investigated in EBC of patients with IPA, compared to controls.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

24Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Invasive pulmonary aspergillosis (IPA)		Patients with proven or probable invasive pulmonary aspergillosis (IPA) (EORTC/MSG criteria) or putative IPA (Blot et al. Am J Respir Crit Care Med 2012)
Controls		Patients without signs of infection.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The identification of biomarkers for invasive pulmonary aspergillosis (IPA) in exhaled breath condensate (EBC)		15 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

hospitalisation in the hematology or intensive care department
age > 16 years
informed consent
proven or probable IPA (EORTC/ MSG criteria)
galactomannan positivity in BAL or serum

Exclusion Criteria:

age < 16 years

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Hospitalized adult patients of the department of Hematology or Intensive Care Unit, University Hospital, Leuven, Belgium

Sampling Method

Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
UZ Leuven		Leuven		3000	Belgium

Condition Browse Module

MeSH Terms

ID	Term
D055744	Invasive Pulmonary Aspergillosis

Ancestor Terms

ID	Term
D055732	Pulmonary Aspergillosis
D001228	Aspergillosis
D009181	Mycoses
D001423	Bacterial Infections and Mycoses

Browse Leaves

Not provided

Browse Branches

Not provided