Non-invasive Diagnosis of Invasive Pulmonary Aspergillosis by Use of Biomarkers in Exhaled Breath Condensate
NIPA
2 other identifiers
observational
101
1 country
1
Brief Summary
In this study, a new, non-invasive method for diagnosis of pulmonary aspergillosis (PA) will be tested in a clinical pilot project.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Apr 2020
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 17, 2020
CompletedFirst Submitted
Initial submission to the registry
April 21, 2020
CompletedFirst Posted
Study publicly available on registry
April 24, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2023
CompletedFebruary 13, 2024
February 1, 2024
3.7 years
April 21, 2020
February 12, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Identification of Aspergillus proteins in the EBC from patients with proven/probable/possible PA
The primary outcome is identification of Aspergillus proteins in the EBC from patients with proven/probable/possible PA
2-3 years
Secondary Outcomes (1)
Detection of Pneumocystis DNA in the EBC
1-2 years
Study Arms (6)
PA proven/probable/possible
15 patients with proven, probable or possible PA
PA suspected, not confirmed
15 patients as the PA patients, but where the diagnosis of PA is rejected.
Healthy controls (PA)
15 subjects of same gender and age as an included patient with proven/probable/possible PA as healthy controls.
Pneumocystis pneumonia positive
Four patients with confirmed pneumocystis pneumonia
Pneumocystis pneumonia negative
If the diagnosis of pneumocystis pneumonia is not confirmed in a patient with suspected pneumocystis pneumonia, the patient will be included as negative control. Four such patients will be included as healthy controls.
Healthy controls (pneumocystis pneumonia)
Four subjects of same gender and age as an included patient with verified pneumocystis pneumonia as healthy controls.
Interventions
The EBC will be collected by use of the RTube(R) system which is commercially available for the purpose of collection of EBC. As the patient breathes through a mouth piece, the exhaled breath is lead through a cooling chamber where the vaporous part of the exhaled breath condenses. The investigators aim at collecting a total minimum of 3.0 mL EBC per study participant in order to have sufficient amount of protein for the subsequent analysis.
The EBC will be collected by use of the RTube(R) system which is commercially available for the purpose of collection of EBC. As the patient breathes through a mouth piece, the exhaled breath is lead through a cooling chamber where the vaporous part of the exhaled breath condenses. The investigators aim at collecting a total minimum of 3.0 mL EBC per study participant in order to have sufficient amount of protein for the subsequent analysis.
Eligibility Criteria
In the main study the investigators expect to include * 15 patients with proven/probable/possible Pulmonary Aspergillosis (PA) * 15 patients with suspected, but rejected PA * 15 healty controls In the substudy the investigators expect to include * 4 patients with verified pnemocystis pneumonia * 4 patients suspected but rejected pneumocystis pneumonia * 4 healthy controls
You may qualify if:
- 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.
- +13 more criteria
You may not qualify if:
- PA patients, pneumocystis pneumonia patients and controls:
- No upper age limit will be applied.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Inger Lise Gadelead
- Aarhus University Hospitalcollaborator
Study Sites (1)
Aalborg Hospital
Aalborg, 9000, Denmark
Biospecimen
1. Exhaled breath condensate (EBC) samples 2. Blood samples 3. Oral wash
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Inger L Gade, MD PhD
Aalborg University Hospital
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal Investigator, Registrar, MD, PhD
Study Record Dates
First Submitted
April 21, 2020
First Posted
April 24, 2020
Study Start
April 17, 2020
Primary Completion
December 31, 2023
Study Completion
December 31, 2023
Last Updated
February 13, 2024
Record last verified: 2024-02