Advanced Early Detection of airway pathogens in children and adults with Cystic Fibrosis during routine follow-up and exacerbation.
- Conditions
- CF and pseudomonas aeroginosa1000401810024970
- Registration Number
- NL-OMON52071
- Lead Sponsor
- Radboud Universitair Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 144
- Patient must be diagnosed with CF and above the age of 5 years old at the
moment of inclusion.
- Patients will be included during a routine visit (n = 70) and can participate
only once during this visit. Some patients will be included during a hospital
visit because of an exacerbation or a Broncho Alveolar Lavage (BAL) visit (N =
35). This means it is possible that the same patient participates twice. One
time as a routine check-up and one time (with a different study number) as an
exacerbation or BAL visit.
- To be able to participate, at least one breath sample is mandatory to
participate. It is preferable to only include patients that are intending to
participate in all elements so that all (4) categories will be well
represented.
(The control group will consist of patients having an elective broncho alveolar
lavage, or patients with CF or conditions that increase the risk of Pseudomonas
aeroginosa infection like extensie bronchiectasis, chronic lung disease will
not be included). The controle group will be above the age of 5 years old.
A patient with serious tachypnea or dyspnea, oxygen need or a patient who is
physically not able to participate, will be excluded from participation in this
study.
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Bacterial culture results for Pseudomonas aeruginosa in cough swab or sputum.<br /><br>PCR result for Pseudomonas aeruginosa in MBS sample.<br /><br>VOC profile compatibility with Pseudomonas aeruginosa colonization / infection.<br /><br>Pseudomonas aeruginosa antibodies detected in serum and mucosal lining fluid.<br /><br>Detection of Pseudomonas aeruginosa in recirculating tissue macrophages by<br /><br>TiMaSCAN<br /><br>Leeds criteria for Pseudomonas aeruginosa infection at time of study visit.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Patient experience of exhaled breath sampling.</p><br>