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.
ID
Bron
Verkorte titel
Aandoening
Cystic Fibosis
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The percentage of concordance of positive TiMaSCAN result for a CF-specific pathogen with result of sputum or BAL cultures
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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.
Onderzoeksopzet
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
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
• 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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
• 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.
Opzet
Deelname
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL9423 |
| CCMO | NL77646.078.21 |
| OMON | NL-OMON51190 |