B96.5
Conditions
Interventions
Group 1: Patients with cystic fibrosis and/or bronchiectasis who are colonized with P. aeruginosa are invited to participate in the study. In addition to routine sputum testing, each participant is as
Sponsors
Universitätsklinkum Heidelberg, Abteilung für Infektiologie und Tropenmedizin
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Able to understand the scope of the study and provide informed consent • Clinical diagnosis of cystic fibrosis based on genetic testing and/or sweat chloride levels; OR diagnosis of non-cystic fibrosis bronchiectasis • Scheduled to provide sputum sample for standard of care procedures on the day of study-specific XBA sample collection • Willing and able to provide AveloCollect and AveloMask XBA samples • Speaking German
Exclusion criteria
Exclusion criteria: • Have been initiated on antimicrobial treatment targeting Pseudomonas aeruginosa = 24h before enrolment to the study • Inability to provide informed consent • Health status (assessed by treating physician at local site) does not allow to use the Avelo devices • Individuals with medical conditions (i.e. severe respiratory conditions) where breath sampling would put unacceptable stress on the patient (as judged by a treating or study physician). • Sputum sample for standard of care procedures was not collected
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility of the detection method and comparison of the detection rate of P. aeruginosa using PCR analysis in XBA, with samples collected using the AveloCollect breath tube and the AveloMask face mask, compared to standard sputum culture and, if applicable, to PCR analysis. | — |
Secondary
| Measure | Time frame |
|---|---|
| Assessment of the user-friendliness and acceptance of breath sample collection using AveloCollect and AveloMask among patients. | — |
Countries
Germany
Contacts
Public ContactClaudia Denkinger
Universitätsklinikum Heidelberg, Abteilung für Infektiologie und Tropenmedizin
Outcome results
None listed