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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

November 23, 2010
November 24, 2010
July 8, 2014
January 2011
July 2014   (Final data collection date for primary outcome measure)
The identification of biomarkers for invasive pulmonary aspergillosis (IPA) in exhaled breath condensate (EBC) [ Time Frame: 15 months ]
The identification of biomarkers for IPA in EBC [ Time Frame: 15 months ]
Complete list of historical versions of study NCT01247142 on ClinicalTrials.gov Archive Site
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Evaluation of Exhaled Breath Condensate in the Diagnosis of Invasive Pulmonary Aspergillosis
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The purpose of this study is to evaluate the diagnostic potential of biomarkers for invasive pulmonary aspergillosis in exhaled breath condensate.
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.
Observational
Time Perspective: Prospective
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Retention:   Samples Without DNA
Description:
exhaled breath condensate
Probability Sample
Hospitalized adult patients of the department of Hematology or Intensive Care Unit, University Hospital, Leuven, Belgium
Invasive Pulmonary Aspergillosis
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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)
  • Controls
    Patients without signs of infection.
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
40
July 2014
July 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
16 Years and older   (Child, Adult, Older Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Belgium
 
 
NCT01247142
S52756
No
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Edith Vermeulen, Universitaire Ziekenhuizen Leuven
Universitaire Ziekenhuizen Leuven
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Universitaire Ziekenhuizen Leuven
July 2014