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RECRUITING
NCT07484607

Understanding Inflammation, InFection and Interventions in Severe Exacerbations of Cystic Fibrosis

Sponsor: Alexander Horsley

View on ClinicalTrials.gov

Summary

The UNIFIED-CF study is an observational study designed to investigate the impacts of treatment given for severe pulmonary exacerbations in people living with cystic fibrosis (pwCF). Exacerbations are episodes when pwCF become more unwell, typically characterised by increased cough, sputum, and breathlessness and treated with a combination of oral and/or intravenous antibiotics. Severe exacerbations require treatment with intravenous antibiotics and impart considerable morbidity on pwCF. In this study, the investigators will recruit people at risk of severe CF exacerbations when they are well and if/when they are subsequently admitted for treatment of an exacerbation, the investigators will track symptoms and lung function during recovery, and collect blood, sputum and stool samples to allow us to explore the biological mechanisms of exacerbations and how they relate to different treatment responses. The study is event driven and will complete recruitment once 125 participants have completed treatment and follow-up for a severe exacerbation event. This study is funded by the Cystic Fibrosis Trust. This study is part of a wider programme of research, led by the PULSE-CF Innovation Hub (and hosted by the University of Manchester). The aim of the Hub is that the data from the UNIFIED-CF study will ultimately support the design of a platform clinical trial to test exacerbation-prevention interventions in CF.

Key Details

Gender

All

Age Range

16 Years - Any

Study Type

OBSERVATIONAL

Enrollment

200

Start Date

2025-10-09

Completion Date

2029-12-31

Last Updated

2026-03-24

Healthy Volunteers

No

Locations (6)

Cardiff and Vale University Health Board

Cardiff, United Kingdom

Royal Devon and Exeter Hospital (Wonford)

Exeter, United Kingdom

Leeds Adult CF Centre

Leeds, United Kingdom

Liverpool Heart & Chest Hospital

Liverpool, United Kingdom

Manchester Adult Cystic Fibrosis Centre

Manchester, United Kingdom

Newcastle Adult CF Centre

Newcastle upon Tyne, United Kingdom