Status:
COMPLETED
Non-invasive Diagnosis of Invasive Pulmonary Aspergillosis by Use of Biomarkers in Exhaled Breath Condensate
Lead Sponsor:
Inger Lise Gade
Collaborating Sponsors:
Aarhus University Hospital
Conditions:
Aspergillosis Pneumonia
Pneumocystis Pneumonia
Eligibility:
All Genders
18+ years
Brief Summary
In this study, a new, non-invasive method for diagnosis of pulmonary aspergillosis (PA) will be tested in a clinical pilot project.
Detailed Description
Background: The search for biomarkers to enhance and improve diagnosis of PA is ongoing, mainly focused on markers detected in the blood and bronchoalveolar lavage (BAL) fluids. In this study, the in...
Eligibility Criteria
Inclusion
- Suspected/confirmed PA patients:
- Hospitalized or ambulatory patients with a suspected PA at Aalborg University Hospital.
- Are conscious and able to understand the given study information.
- Possess legal capacity.
- Age above 18 years.
- Informed, signed consent is obtained.
- Clinically stable, which is defined as patients with stable blood pressure and not in need for other treatments.
- No need for organ support, which comprises need for vasopressors or inotropes, mechanical ventilation, extra corporal circulation or renal replacement therapy.
- Controls
- • Patients as the PA patients, but where the diagnosis of PA is rejected will be included as controls.
- Suspected/confirmed pneumocystis pneumonia patients:
- Hospitalized or ambulatory patients with a suspected pneumocystis pneumonia at Aalborg University Hospital - chest x-ray must support the tentative diagnosis of pneumocystis pneumonia.
- Are conscious and able to understand the given study information.
- Possess legal capacity.
- Age above 18 years.
- Informed, signed consent is obtained.
- Clinically stable, which is defined as patients with stable blood pressure and not in need for other treatments.
- No need for organ support, which comprises need for vasopressors or inotropes, mechanical ventilation, extra corporal circulation or renal replacement therapy.
- Controls
- • Patients as the pneumocystis pneumonia patients, but where the diagnosis is rejected.
- Healthy controls for the confirmed PA patients and confirmed pneumocystis pneumonia patients In addition, 19 healthy controls (i.e. patients/subjects who undergo diagnostic work-up for benign or indolent hematological diseases without suspected PA or pneumocystis pneumonia) will be recruited, as described below.
- Healthy controls and patients who are going through diagnostic work-up for indolent hematological cancer types or benign hematological diseases, at the Department of Hematology, Aalborg University Hospital.
- Same gender and age (within a 10-year range) as an included patient with proven/probable/possible PA (15 subjects).
- Same gender and age (within a 10-year range) as an included patient with verified pneumocystis pneumonia (4 subjects).
- Are conscious and able to understand the given study information.
- Possess legal capacity.
- Age above 18 years.
- Informed, signed consent is obtained.
Exclusion
- PA patients, pneumocystis pneumonia patients and controls:
- No upper age limit will be applied.
Key Trial Info
Start Date :
April 17 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2023
Estimated Enrollment :
101 Patients enrolled
Trial Details
Trial ID
NCT04358419
Start Date
April 17 2020
End Date
December 31 2023
Last Update
February 13 2024
Active Locations (1)
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1
Aalborg Hospital
Aalborg, Denmark, 9000