Evaluation of Exhaled Breath Condensate in the Diagnosis of Invasive Pulmonary Aspergillosis
This study has been completed.
Sponsor:
Universitaire Ziekenhuizen Leuven
Information provided by (Responsible Party):
Edith Vermeulen, Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:
NCT01247142
First received: November 23, 2010
Last updated: July 4, 2014
Last verified: July 2014
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Purpose
The purpose of this study is to evaluate the diagnostic potential of biomarkers for invasive pulmonary aspergillosis in exhaled breath condensate.
| Condition |
|---|
|
Invasive Pulmonary Aspergillosis |
| Study Type: | Observational |
| Study Design: | Time Perspective: Prospective |
Resource links provided by NLM:
Further study details as provided by Universitaire Ziekenhuizen Leuven:
Primary Outcome Measures:
- The identification of biomarkers for invasive pulmonary aspergillosis (IPA) in exhaled breath condensate (EBC) [ Time Frame: 15 months ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples Without DNA
exhaled breath condensate
| Enrollment: | 24 |
| Study Start Date: | January 2011 |
| Study Completion Date: | July 2014 |
| Primary Completion Date: | July 2014 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
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)
|
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Controls
Patients without signs of infection.
|
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.
Eligibility| Ages Eligible for Study: | 16 Years and older (Child, Adult, Senior) |
| Genders Eligible for Study: | Both |
| 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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Please refer to this study by its ClinicalTrials.gov identifier: NCT01247142
Please refer to this study by its ClinicalTrials.gov identifier: NCT01247142
Locations
| Belgium | |
| UZ Leuven | |
| Leuven, Belgium, 3000 | |
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
More Information
| Responsible Party: | Edith Vermeulen, PhD fellow, Universitaire Ziekenhuizen Leuven |
| ClinicalTrials.gov Identifier: | NCT01247142 History of Changes |
| Other Study ID Numbers: | S52756 |
| Study First Received: | November 23, 2010 |
| Last Updated: | July 4, 2014 |
| Health Authority: | Belgium: Ethics Committee |
Keywords provided by Universitaire Ziekenhuizen Leuven:
|
invasive pulmonary aspergillosis exhaled breath condensate |
Additional relevant MeSH terms:
|
Aspergillosis Pulmonary Aspergillosis Invasive Pulmonary Aspergillosis Hyalohyphomycosis Dermatomycoses Skin Diseases, Infectious |
Infection Mycoses Skin Diseases Lung Diseases, Fungal Lung Diseases Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on September 30, 2016