Influence of chronic Pseudomonas aeruginosa infection on airway inflammation during respiratory viral infections in adults with cystic fibrosis (CHRONOVIR)
- Conditions
- E84Cystic fibrosis
- Registration Number
- DRKS00026774
- Lead Sponsor
- niversitätsklinikum Frankfurt am Main
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 30
Age = 18 years.
- Confirmed diagnosis of CF by genetic testing.
- Regular patient of the Christiane Herzog CF Center Frankfurt with data from at least two routine check-ups and one annual check-up in the 12 months prior to inclusion in the study.
- PA free OR chronic pulmonary infection with PA.
- Written informed consent.
- Z.n. lung transplantation.
- Life expectancy < 6 months or listed for lung transplantation.
- Systemic steroid therapy.
- Intravenous antibiotic therapy in the last 4 weeks.
- Last pulmonary infection exacerbation (clinical definition: indication for anti-infective therapy (oral/intravenous).
- Intermittent PA infection
- Other chronic disease or infection with pulmonary infection not associated with CF (such as tuberculosis, lung carcinoma).
- Pregnancy
- Known alcohol or drug abuse.
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in local and systemic inflammatory markers (differential blood count, C-reactive protein, concentration of pro-inflammatory cytokines and chemokines including IL-6, IL-1ß, CXCL-8, CXCL-10) in sputum and serum in patients with and without chronic PA infection.
- Secondary Outcome Measures
Name Time Method - Number of positive viral detections in patients with and without chronic PA infection.<br>- Number of exacerbations in patients with and without chronic PA infection during the observation period (prospective) and in the past 12 months before inclusion.<br>- Pulmonary Functional Progression (FEV-1).<br>- Transcriptome/gene expression analyses (Paxgene).