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

Invasive Pulmonary Aspergillosis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01247142
• Other study ID #: S52756
• Status: Completed
• Phase: N/A
• First received: November 23, 2010
• Last updated: July 4, 2014
• Start date: January 2011
• Est. completion date: July 2014

Study information

• Verified date: July 2014
• Source: Universitaire Ziekenhuizen Leuven
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 16 Years and older

Eligibility

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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Aspergillosis
• Invasive Pulmonary Aspergillosis
• Pulmonary Aspergillosis

Locations

Country	Name	City	State
Belgium	UZ Leuven	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The identification of biomarkers for invasive pulmonary aspergillosis (IPA) in exhaled breath condensate (EBC)		15 months	No