Headline of the Month: Appendix A2 recruitment can resume following Amendment 07 local implementation
Appendix A1
Appendix A1 remains temporarily halted in the UK while Sponsor activities to support the Investigational Medicinal Product – clofazimine, supply arrangements continue. Formal pharmacy involvement and sponsor-led supply arrangements are required before UK recruitment resumes.
Appendix A2
Regulatory approval for Amendment 07 has been granted to re-classify clofazimine as a non-Investigational Medicinal Product in Appendix A2. Sites may resume recruitment into Appendix A2 when this amendment has been implemented by their local Research and Innovation department. Study drugs remain standard of care and are sourced locally by sites.
Non-CF Recruitment Expansion in the UK
Sites cannot recruit non-CF participants at this time. Regulatory approval is pending to expand recruitment to non-CF patients in the UK. The Sponsor is actively working to secure funding for this expansion. Sites will be notified once regulatory approval is in place.
UK Recruitment at a Glance
| UK participants recruited to date | 2 (at Nottingham University Hospitals NHS Trust) |
| New participants recruited this month | 0 |
| UK sites currently open | 5 |
UK Sites
| Active/Open UK Sites | • Western General Hospital. • Royal Hospital Children's Hospital. • Nottingham Children and Young Persons’ CF centre (Queen’s Medical Centre Campus). • Welcome Wolfson Adult CF Centre (City Hospital campus). • Southampton General Hospital. |
| Sites in the Pipeline | • Wythenshawe Hospital. • Royal Manchester Children's Hospital. • Bristol Royal Hospital for Children. • University Hospital Llandough. • Ninewells Hospital. • Belfast City Hospital. |
Keep Recruiting – Every Participant Counts!
Recruitment remains a key priority, and we encourage all sites to continue identifying and screening potential participants whenever possible. Every enrolment helps us move closer to achieving our recruitment targets and generating meaningful study outcomes. If you have any questions about eligibility, screening, or recruitment processes, please do not hesitate to reach out to the FORMaT Project Management team by email at formattrial@health.qld.gov.au.
We appreciate your continued efforts and enthusiasm in supporting the success of the trial. Together, we can make a real difference.
First Interim Analysis Update
The first interim analysis has been completed. Following review, the independent Data Safety Monitoring Board recommended that all treatment arms remain open, as there was insufficient data at this stage to support dropping any arm. A novel Intensive Treatment Arm D (combination of intravenous (IV) Sulbactam-Durlobactam (SUL-DUR) with IV ceftriaxone, oral amoxicillin, azithromycin and clofazimine) will be introduced to the FORMaT platform. The Sulbactam-Durlobactam is being provided in-kind by our industry partner – Innoviva Specialty Therapeutics (IST).
Electronic Site File Reminders
- Electronic Investigator Site File (eISF) access is provided to sites following formal site activation unless the Sponsor confirms otherwise.
- Signed, dated Curriculum Vitaes and current Good Clinical Practice certificates must be collected and uploaded to SiteDocs after site activation/training.
- Any meeting minutes are to be filed in the Site Management folder of the eISF.
- Sites are to notify FORMaT Project Management team of any document control issues identified in their eISF.
Site Spotlight – Southampton General Hospital
Thank you to the Southampton team for continued engagement, identifying a potential observational cohort participant and confirming implementation of Amendment 07. Please continue to keep FORMaT in mind during clinics and microbiological review.