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Monocytes in TiMaSCAN for monitoring respiratory infections in CF

Monocytes in TiMaSCAN for monitoring respiratory infections in CF. Measuring bacterial contents of immune cells reveals bacterial response to antibiotic therapy during exacerbations in CF

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON25786
Enrollment
20
Registered
2021-04-22
Start date
2021-08-02
Completion date
Unknown
Last updated
2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cystic Fibosis

Interventions

None listed

Sponsors

N.a.
Lead Sponsor

Eligibility

Inclusion criteria

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

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 outcomes

Primary

MeasureTime frame
The percentage of concordance of positive TiMaSCAN result for a CF-specific pathogen with result of sputum or BAL cultures

Secondary

MeasureTime frame
- 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)

Contacts

Public ContactWendy Unger

Erasmus MC

w.unger@erasmusmc.nl010-7044654

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)