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

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ClinicalTrials.gov Identifier: NCT01247142
Recruitment Status : Completed
First Posted : November 24, 2010
Last Update Posted : July 8, 2014
Sponsor:
Information provided by (Responsible Party):
Edith Vermeulen, Universitaire Ziekenhuizen Leuven

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The purpose of this study is to evaluate the diagnostic potential of biomarkers for invasive pulmonary aspergillosis in exhaled breath condensate.

Condition or disease
Invasive Pulmonary Aspergillosis

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.

Study Design
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Study Type : Observational
Actual Enrollment : 24 participants
Time Perspective: Prospective
Study Start Date : January 2011
Actual Primary Completion Date : July 2014
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aspergillosis
U.S. FDA Resources

Groups and Cohorts
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort
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.


Outcome Measures
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. The identification of biomarkers for invasive pulmonary aspergillosis (IPA) in exhaled breath condensate (EBC) [ Time Frame: 15 months ]

Biospecimen Retention:   Samples Without DNA
exhaled breath condensate

Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01247142


Locations
Belgium
UZ Leuven
Leuven, Belgium, 3000
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Edith Vermeulen, PhD fellow, Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT01247142     History of Changes
Other Study ID Numbers: S52756
First Posted: November 24, 2010    Key Record Dates
Last Update Posted: July 8, 2014
Last Verified: July 2014

Keywords provided by Edith Vermeulen, Universitaire Ziekenhuizen Leuven:
invasive pulmonary aspergillosis
exhaled breath condensate

Additional relevant MeSH terms:
Aspergillosis
Pulmonary Aspergillosis
Invasive Pulmonary Aspergillosis
Mycoses
Hyalohyphomycosis
Dermatomycoses
 Lung Diseases, Fungal
Skin Diseases, Infectious
Skin Diseases
Lung Diseases
Respiratory Tract Diseases
Invasive Fungal Infections