1. To investigate whether transmission of P. aeruginosa strains between CF patients occurs during a 1 day open air event and if so, whether there are patient-factors contributing to transmission. 2. To evaluate whether transmitted strains persist…
ID
Source
Brief title
Condition
- Chromosomal abnormalities, gene alterations and gene variants
- Bacterial infectious disorders
- Lifestyle issues
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The number of (possible/ probable) transmissions e.g. the number of patients in
which a P. aeruginosa MLVA type was found that was also found in another
patient and that was not present in the first sputum sample.
Secondary outcome
• The number of patients in whom transmission has (possibly/ probably) occurred
and in whom the MLVA type can still be found after 3 months i.e. duration of
colonization by a new MLVA type.
• Patient characteristics that are associated with transmission of P.
aeruginosa strains e.g. age, sex, health status ate the time of the event (i.e.
whether the patient has an episode of upper respiratory tract infection, time
to last exacerbation) and whether patients say they adhered to hygiene rules
provided by the organisers.
Background summary
Several reports have concluded that transmission of certain highly prevalent
and sometimes highly virulent strains Pseudomonas aeruginosa strains among
cystic fibrosis (CF) patients is possible during events in which there is close
contact, e.g. summer camps. Because of a possible risk of transmission,
segregation measures have been put into practice and in the Netherlands,
meetings for CF patients like summercamps have been discontinued as of 2006. A
group of teenage CF patients however started organizing a 1 day open air event
each year in the summer, since 2005. Many young CF patients have participated
in this event. It is not clear whether P. aeruginosa strains are transmitted
during such 1 day open air events.
Study objective
1. To investigate whether transmission of P. aeruginosa strains between CF
patients occurs during a 1 day open air event and if so, whether there are
patient-factors contributing to transmission. 2. To evaluate whether
transmitted strains persist after three months.
Study design
Longitudinal observational study.
Study burden and risks
The burden of participation will be the production of three sputum samples, one
throat- and nasal swab and the filling out of two short questionnaires. The
first sample will be collected before patients enter the event, along with the
filling out of the first questionnaire. The second sample will be collected as
the patients leave the event, along with which patients will receive the second
questionnaire, which can be filled out at home. The third sample will be
produced at home, three months after the event. This last sample can be sent to
the investigators by mail, so it will not involve any home visits. We consider
there to be no additional risks involved in participating in this study. Sputum
production is not related to additional risks. In case of not being able to
produce sputum, a throat swab will be taken, which comes with a very low risk.
Patients who visit CFBD do so on a voluntary basis. Knowledge on the occurrence
of transmission of P. aeruginosa during open air events for CF patients is
needed for adequate patient/parent education on this subject.
Lundlaan 6
3584 EA
Nederland
Lundlaan 6
3584 EA
Nederland
Listed location countries
Age
Inclusion criteria
CF patients who attend the CF Beach Dance event and who give informed consent
Exclusion criteria
none
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 | NL26112.041.08 |