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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Edith Vermeulen, Universitaire Ziekenhuizen Leuven

ClinicalTrials.gov Identifier:

NCT01247142

First received: November 23, 2010

Last updated: July 4, 2014

Last verified: July 2014

History of Changes

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:	Time Perspective: Prospective

Resource links provided by NLM:

MedlinePlus related topics: Aspergillosis

Genetic and Rare Diseases Information Center resources: Aspergillosis

U.S. FDA Resources

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


Enrollment:	24
Study Start Date:	January 2011
Study Completion Date:	July 2014
Primary Completion Date:	July 2014 (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) or putative IPA (Blot et al. Am J Respir Crit Care Med 2012)
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 or Intensive Care Unit, University Hospital, Leuven, Belgium

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01247142

Locations


Belgium
UZ Leuven
Leuven, Belgium, 3000

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:	July 4, 2014
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 Dermatomycoses Hyalohyphomycosis Infection	Lung Diseases Lung Diseases, Fungal Mycoses Respiratory Tract Diseases Skin Diseases Skin Diseases, Infectious

ClinicalTrials.gov processed this record on February 25, 2015

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