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

This study is currently recruiting participants.
Verified June 2012 by Universitaire Ziekenhuizen Leuven
Sponsor:
Information provided by (Responsible Party):
Edith Vermeulen, Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:
NCT01247142
First received: November 23, 2010
Last updated: June 4, 2012
Last verified: June 2012
  Purpose

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


Condition
Invasive Pulmonary Aspergillosis

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by Universitaire Ziekenhuizen Leuven:

Primary Outcome Measures:
  • The identification of biomarkers for invasive pulmonary aspergillosis (IPA) in exhaled breath condensate (EBC) [ Time Frame: 15 months ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

exhaled breath condensate


Estimated Enrollment: 20
Study Start Date: January 2011
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Invasive pulmonary aspergillosis (IPA)
Patients with proven or probable invasive pulmonary aspergillosis (IPA) (EORTC/MSG criteria)
Controls
Patients without signs of infection.

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.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Hospitalized adult patients of the department of Hematology, University Hospital, Leuven, Belgium

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • age < 16 years
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01247142

Contacts
Contact: Edith Vermeulen +32 16 34 79 25 edith.vermeulen@uzleuven.be

Locations
Belgium
UZ Leuven Recruiting
Leuven, Belgium, 3000
Principal Investigator: Katrien Lagrou         
Sub-Investigator: Edith Vermeulen         
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
  More Information

No publications provided

Responsible Party: Edith Vermeulen, PhD fellow, Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT01247142     History of Changes
Other Study ID Numbers: S52756
Study First Received: November 23, 2010
Last Updated: June 4, 2012
Health Authority: Belgium: Ethics Committee

Keywords provided by Universitaire Ziekenhuizen Leuven:
invasive pulmonary aspergillosis
exhaled breath condensate

Additional relevant MeSH terms:
Aspergillosis
Invasive Pulmonary Aspergillosis
Pulmonary Aspergillosis
Mycoses
Lung Diseases, Fungal
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 14, 2014