Monocytes in TiMaSCAN for monitoring respiratory infections in CF

Conditions: Cystic Fibosis

Registration Number: NL-OMON25786

Lead Sponsor: .a.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 20

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.

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The percentage of concordance of positive TiMaSCAN result for a CF-specific pathogen with result of sputum or BAL cultures

Secondary Outcome Measures

Name	Time	Method
- The percentage of disconcordance of positive TiMaSCAN result for a CF specific pathogen with the result of sputum or cough swab cultures.<br>- Correlation pathogen-positive TiMas with lung function<br>- Correlation pathogen-positive TiMas with mean change in CFRSD/CRISS score and CFQ-R<br>- 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)<br>