Clinical and Immunological Categorization of Pulmonary Aspergillosis in Cystic Fibrosis
Recruiting
- Conditions
- E84B44Cystic fibrosisAspergillosis
- Registration Number
- DRKS00012862
- Lead Sponsor
- Charite Universitätsmedizin Berlin
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 200
Inclusion Criteria
Provide written informed consent
- Confirmed diagnosis of CF
- Aged between 6 and 70 years
- Ability to do a lung function test and to provide sputum samples for microbiological evaluation
Exclusion Criteria
Participants will not be entered in the study for any of the following exclusion criteria:
- Patients unable to sign informed consent or unwilling to comply with the procedural
requirements of this clinical protocol.
- No ability to do a lung function test and to provide sputum samples for microbiological evaluation.
- Not possible to take blood
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Clinical confirmation of 6 distinct pulmonary aspergillosis stages: <br>1)Af Colonization<br>2)Af Sensitization1)<br>3)Non-allergic bronchopulmonary aspergillosis (Af bronchitis) <br>4)Allergic bronchopulmonary aspergillosis (ABPA)<br>5)Invasive pulmonary aspergillosis (Af-pneumonia)<br>6)Aspergilloma (chronic pulmonary aspergillosis)<br>
- Secondary Outcome Measures
Name Time Method - Lung function changes based on each of the above mentioned aspergillosis stages<br><br>- Validated new biomarker(s) indicative for <br>1) Af Colonization: Af in sputum, qPCR<br>2) Af Sensitization: Af specific IgG and IgE, Galctomannan Index. <br>3) Af bronchitis: qPCR in sputum, no increased IgE <br>4) ABPA: total IgE, Af specific IgE, sputum, Galactomannan Index. <br>5) Af-pneumonia: T-cell reactivity of the fungal proteins<br>6) Aspergilloma: sputum, radiological imaging<br><br>- Characterization of pathogen-Af interaction<br><br>