Comparison of lower airway sampling strategies in children with protracted bacterial bronchitis

Not Applicable

• Conditions: Protracted bacterial bronchitis; Respiratory

• Registration Number: ISRCTN79883982
• Lead Sponsor: niversity Hospitals of North Midlands NHS Trust

Brief Summary

2022 Protocol article in https://doi.org/10.1136/bmjpo-2022-001722 (added 17/01/2023)

Detailed Description

Not available

Study Timeline

• Study Start: 2021-11-08
• Last Update Posted: 15 July 2024
• Study Completion: 2024-07-30

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 137

Inclusion Criteria

1. Aged 1-10 years
2. Have a clinical diagnosis of PBB
3. Referred for a clinically indicated FB-BAL
4. Parent/guardian willing and able to give fully informed consent
5. Willing and able to comply with the study procedures

Exclusion Criteria

1. Diagnosis of bronchiectasis, cystic fibrosis or immunodeficiency
2. FB-BAL being performed for a therapeutic indication (i.e. lobar collapse) rather than for lower airway
3. Currently taking part in another interventional study
4. Non-English speaker where translation facilities are insufficient to guarantee informed consent

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Discordance of pathogen yield between induced sputum and FB-BAL approximately 48-72 hours post-procedure. If the same organisms are not identified in both samples the pathogen yield is discordant. Discordance will be classified as CS+/FB-BAL- when an organism is isolated on cough swab but not on FB-BAL or CS-/FB-BAL+ when an organism is isolated on the FB-BAL but not on the cough swab.<br>2. Discordance of pathogen yield between cough swab and FB-BAL approximately 48-72 hours post-procedure. If the same organisms are not identified in both samples the pathogen yield is discordant. Discordance will be classified as IS+/FB-BAL- when an organism is isolated on induced sputum but not on FB-BAL or IS-/FB-BAL+ when an organism is isolated on FB-BAL but not on induced sputum.

Secondary Outcome Measures

Name	Time	Method
1. The sensitivity of each sampling technique calculated from triplicate (CS/is/BAL) culture results approximately 48-72 hours post-procedure.<br>2. Success of sputum induction collected via the case report form (CRF) on the day of sample collection<br>3. Tolerability of sampling techniques using Tolerability Questionnaire on the day of sample collection