MONITOR CF: Monocytes In TiMaSCAN for monitoring respiratory infections in Cystic Fibrosis
- Conditions
- Cystic Fibrosis100386861000401810010613
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 20
• 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.
A potential subject who meets any of the following criteria will be excluded
from participation in this study:
• 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.
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>OBJECTIVE 1 - Validate qualitative TiMaSCAN results as diagnostic tool<br /><br>Hypothesis 1A. TiMaSCAN results, expressed as positive or negative for<br /><br>CF-specific pathogens, will correlate with results from (lower) airway cultures.<br /><br><br /><br>Primary endpoint: percentage of concordance of positive TiMaSCAN result for a<br /><br>CF specific pathogen with result of sputum or BAL cultures</p><br>
- Secondary Outcome Measures
Name Time Method