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ID
Source
Brief title
Health condition
Cystic Fibosis
Sponsors and support
Intervention
Outcome measures
Primary outcome
The percentage of concordance of positive TiMaSCAN result for a CF-specific pathogen with result of sputum or BAL cultures
Secondary outcome
- The percentage of disconcordance of positive TiMaSCAN result for a CF specific pathogen with the result of sputum or cough swab cultures.
- Correlation pathogen-positive TiMas with lung function
- Correlation pathogen-positive TiMas with mean change in CFRSD/CRISS score and CFQ-R
- Correlation number of pathogen-positive TiMas at end of treatment with time to next exacerbation, with either oral or iv treatment (follow up of maximum one year)
Background summary
Proper diagnosis and treatment of lung infections in children with Cystic Fibrosis (CF) is important because damage to the lungs from infections reduces life expectancy. The choice of treatment (antibiotics) and duration thereof is now based on symptoms, lung function and suboptimal lab results. A new rapid test that can detect infections, developed at the Sophia Children's Hospital, may contribute to better diagnostics. In this project we would like to apply this test in children with CF and investigate whether this contributes to better detection of infections in the lungs. This can improve treatment.
Study objective
Our hypothesis is that TiMaSCAN results will correlate with airway cultures and that the amount of pathogen-positive TiMas will decrease over the course of antibiotic treatment.
Study design
Day of admission:
- Baseline characteristics (such as age, gender, mutation, growth, antibiotic and other medication are collected (n=20))
- If applicable, from some patients BALF will be obtained by bronchoscopy
Start of intravenous antibiotics treatment (day 0)
- Spirometry
- sputum for culture
- EDTA blood samples for TiMaSCAN
- CFRSD/CRISS questionnaire
After one week of treatment (day 7):
- Spirometry
- sputum for culture
- EDTA blood samples for TiMaSCAN
- CFRSD/CRISS questionnaire
End of treatment (day 14)
- Spirometry
- sputum for culture
- EDTA blood samples for TiMaSCAN
- CFRSD/CRISS questionnaire
Usually an iv antibiotic course is 2 weeks, if it is 3 weeks, then there will be an extra study time point after 2 weeks
Inclusion criteria
• Diagnosed with CF, either by abnormal sweat test and/or confirmed with 2 mutations found by genetic analysis, either from heel-prick screening or diagnosed later in life;
• Aged 5 – 18 years at time of hospitalization;
• Able to perform lung function test;
• Having an indication to receive intravenous antibiotic treatment because of a pulmonary exacerbation
• Authorized by a written informed consent from parents (and patient, if aged > 12) to collect a vial of EDTA blood from i.v. canula, to undergo a sputum induction (if sputum collection is not possible, a cough swab is collected) and to assess lung function, and permission to use excess biomaterials and coded clinical data for research.
Parents may choose to opt in or out for separate parts of the study.
Exclusion criteria
• Diagnosed with allergic bronchopulmonary Aspergillosis
• Use of prednisone
• Antibiotic iv treatment has already been started more than 12 hours before collection of first blood and/or sputum cultures
• Use of inhaled antibiotics during antibiotic iv course.
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL9423 |
| CCMO | NL77646.078.21 |
| OMON | NL-OMON51190 |