- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01247142
Evaluation of Exhaled Breath Condensate in the Diagnosis of Invasive Pulmonary Aspergillosis
July 4, 2014 updated by: Edith Vermeulen, Universitaire Ziekenhuizen KU Leuven
The purpose of this study is to evaluate the diagnostic potential of biomarkers for invasive pulmonary aspergillosis in exhaled breath condensate.
Study Overview
Status
Completed
Conditions
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 Type
Observational
Enrollment (Actual)
24
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Leuven, Belgium, 3000
- UZ Leuven
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (ADULT, OLDER_ADULT, CHILD)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Hospitalized adult patients of the department of Hematology or Intensive Care Unit, University Hospital, Leuven, Belgium
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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)
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Controls
Patients without signs of infection.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The identification of biomarkers for invasive pulmonary aspergillosis (IPA) in exhaled breath condensate (EBC)
Time Frame: 15 months
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15 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2011
Primary Completion (ACTUAL)
July 1, 2014
Study Completion (ACTUAL)
July 1, 2014
Study Registration Dates
First Submitted
November 23, 2010
First Submitted That Met QC Criteria
November 23, 2010
First Posted (ESTIMATE)
November 24, 2010
Study Record Updates
Last Update Posted (ESTIMATE)
July 8, 2014
Last Update Submitted That Met QC Criteria
July 4, 2014
Last Verified
July 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- S52756
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Invasive Pulmonary Aspergillosis
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