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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01247142

Enrollment

Registered

2010-11-24

Start date

2011-01-31

Completion date

2014-07-31

Last updated

2014-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Invasive Pulmonary Aspergillosis

Keywords

invasive pulmonary aspergillosis, exhaled breath condensate

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.

Interventions

None listed

Study design

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

16 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Countries

Belgium

Outcome results