Primary Objective: To investigate the yield of two methods of exhaled breath analysis (PCR based and VOC based) in the detection of Pseudomonas aeruginosa colonization or infection in young patients with cystic fibrosis (CF).Secondary Objective(s):…
ID
Source
Brief title
Condition
- Bacterial infectious disorders
- Respiratory tract infections
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
Patient experience of exhaled breath sampling.
Background summary
With this study we would like to investigate the potential of new, innovative
ways of detecting Pseudomonas aeruginosa in patients with cystic fibrosis (CF)
during and outside of exacerbations. We will use two ways of exhaled breath
analysis: a polymerase chain reaction (PCR) based technique with the Modular
Breath Sampler (MBS) and a targeted volatile organic components (VOC) analysis.
Next to exhaled breath, we will analyze mucosal lining fluid (MLF) for the
presence of antibodies against Pseudomonas. Results of these techniques will be
compared to the traditional bacterial cultures done with coughswabs, sputum
culture or broncho alveolar lavage (BAL). Patients will be categorized for
Pseudomonas status according to the Leeds criteria. The potential of the new
techniques in early detection of Pseudomonas will be investigated.
Study objective
Primary Objective:
To investigate the yield of two methods of exhaled breath analysis (PCR based
and VOC based) in the detection of Pseudomonas aeruginosa colonization or
infection in young patients with cystic fibrosis (CF).
Secondary Objective(s):
In view of the detection of Pseudomonas aeruginosa in young patients with CF:
to correlate the results of two methods of exhaled breath analysis with the
current *gold standard* of diagnostics: bacterial culture and serology.
To analyze / model the additive value of innovative diagnostics like exhaled
breath analysis and mucosal lining fluid analysis in the early detection of
Pseudomonas aeruginosa in young patients with CF.
Study design
This will be an explorative multicentre cross-sectional prospective study among
young patients with CF that will be seen in the Radboudumc or MUMC+, during
their routine (uniform) check-up and during exacerbations during the period of
September 2021- until December of 2022. A group of elective patients undergoing
a BAL will be included as control subjects for the breath samples.
Study burden and risks
The burden associated with participation, will be 30 minutes that are asked
from the patient. In these 30 minutes, additional information will be given,
Informed Consent will be signed and two different breath samples will be
collected. There will also be a mucosal lining fluid (MLF nose strip) sample
collected and an additional blood sample will be collected during regular
labwork (therefore not forming a higher risk for complications, compared to the
regular check-up that is taking place). In the past, the MBS and VOC samples
have been considered *not WMO mandatory* by the MREC.
There are no extra risks for the study participant. All the samples that are
needed, will be collected just once and it will all be on the same day. No
additional physical examination will be needed.
Most patients with CF will develop Pseudomonas aeruginosa colonization /
infection during childhood or early adulthood. Therefore the young CF patients
form a unique population and this study cannot be performed in adults only.
For the controlgroup this will be only 2 breath samples, this will take about
20 minutes.
Geert Grooteplein-Zuid 10
Nijmegen 6525 GA
NL
Geert Grooteplein-Zuid 10
Nijmegen 6525 GA
NL
Listed location countries
Age
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
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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL79103.091.21 |