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

NCT ID: NCT01247142

Last Updated: 2014-07-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

24 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-01-31

Study Completion Date

2014-07-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Invasive Pulmonary Aspergillosis

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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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)

No interventions assigned to this group

Controls

Patients without signs of infection.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role lead

Responsible Party

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Edith Vermeulen

PhD fellow

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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UZ Leuven

Leuven, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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S52756

Identifier Type: -

Identifier Source: org_study_id

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