BEAT CF: Pulmonary Exacerbations Treatment Platform - Adjunct Antibiotics Domai

Not Applicable

Recruiting

• Conditions: Cystic Fibrosis; Human Genetics and Inherited Disorders - Cystic fibrosis

• Registration Number: ACTRN12622001063707
• Lead Sponsor: niversity of Sydney

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-08-01
• Last Update Posted: 30 January 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 5000

Inclusion Criteria

1. Be enrolled in the BEAT CF PEx Cohort (ACTRN12621000638831).
2. Documented informed consent to participate in the Adjunct antibiotic Domain.
3. Are eligible for at least two Interventions in the Adjunct Antibiotic Domain available at the clinical Site (including no Adjunct Antibiotic).
4. Must be able to reliably perform spirometry.

Exclusion Criteria

1. The person is unable to reliably perform spirometry (for example due to young age)
2. The person’s Responsible Clinician deems enrolment in the PEx Adjunct Antibiotic Domain is not in their best interest.

A participant will be excluded from Assignment to a specific Intervention in the Adjunct Antibiotic Domain if:
1. They have a known or suspected significant drug hypersensitivity to tobramycin or other aminoglycosides
2. Recognised contraindication to IV tobramycin, including known renal, auditory or vestibular impairment which, in the opinion of the Responsible Clinician, precludes its use.
3. The Intervention is deemed unacceptable by the Responsible Clinician e.g. because of a poor treatment response to that antibiotic (requiring a change in antibiotic treatment) in the preceding 12 months

Study & Design

• Study Type: Interventional
• Study Design: Not specified