Advanced Early Detection of airway pathogens in children and adults with Cystic Fibrosis during routine follow-up and exacerbation.

Advanced Early Detection of airway pathogens in children and adults with Cystic Fibrosis during routine follow-up and exacerbation. - AED-CF

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON52071

Enrollment

144

Registered

2022-02-02

Start date

2022-03-14

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

CF and pseudomonas aeroginosa

Interventions

None listed

Eligibility

Age

2 Years to 64 Years

Inclusion criteria

Inclusion criteria: - 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
Bacterial culture results for Pseudomonas aeruginosa in cough swab or sputum. PCR result for Pseudomonas aeruginosa in MBS sample. VOC profile compatibility with Pseudomonas aeruginosa colonization / infection. Pseudomonas aeruginosa antibodies detected in serum and mucosal lining fluid. Detection of Pseudomonas aeruginosa in recirculating tissue macrophages by TiMaSCAN Leeds criteria for Pseudomonas aeruginosa infection at time of study visit.	—

Measure

Time frame

Bacterial culture results for Pseudomonas aeruginosa in cough swab or sputum. PCR result for Pseudomonas aeruginosa in MBS sample. VOC profile compatibility with Pseudomonas aeruginosa colonization / infection. Pseudomonas aeruginosa antibodies detected in serum and mucosal lining fluid. Detection of Pseudomonas aeruginosa in recirculating tissue macrophages by TiMaSCAN Leeds criteria for Pseudomonas aeruginosa infection at time of study visit.

—

Secondary

Measure	Time frame
Patient experience of exhaled breath sampling.	—

Countries

Netherlands

Outcome results