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Completed

NCT Number: NCT01247142

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

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

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Key information

Conditions

Invasive Pulmonary Aspergillosis Aspergillosis Bacterial Infections and Mycoses Infections Invasive Fungal Infections Lung Diseases Lung Diseases, Fungal Mycoses Pulmonary Aspergillosis Respiratory Tract Diseases

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

UZ Leuven

Leuven, 3000, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. The identification of biomarkers for invasive pulmonary aspergillosis (IPA) in exhaled breath condensate (EBC)

    Time frame: 15 months

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Nov 24, 2010
Registry last updated
Jul 8, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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