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

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Currently Recruiting

This trial is actively seeking participants in the UK. Discuss eligibility with your patient.

Status

Recruiting

Phase

N/A

NCT ID

NCT07484607

Trial 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.

Lead Sponsor: Alexander Horsley

Participants: ALL

Start Date: 2025-10-09

Primary Completion: 2029-12-31

Min Age: 16 Years

Eligibility Criteria

Inclusion Criteria: 1. Confirmed diagnosis of cystic fibrosis (CF), defined as presence of two pathogenic CF-causing CFTR mutations AND clinical features consistent with a diagnosis of CF, OR presence of at least one pathogenic CF-causing CFTR mutation AND sweat chloride (before use of CFTR modulators) >60mmol/L AND clinical features consistent with a diagnosis of CF. 2. Receiving care from a UK Adult Cystic Fibrosis Centre taking part in the study. 3. EITHER: • Have had at least 1 previous exacerbation of CF lung disease, treated with intravenous antibiotics, in the previous 12 months. OR • Enrolled in the CF-Tracker study (IRAS ID 338539) within the last 24 months (dated from date of completion of baseline Tracker visit) 4. In case of treatment for an exacerbation, likely to be treated with a ß-lactam or an anti-pseudomonal penicillin, combined with tobramycin or colistin, per CF Trust and NICE guidelines for 1st-line CF therapies. 5. Able to produce sputum (spontaneous or induced) at baseline visit. 6. Able to understand the patient information sheet, willing to consent to study protocol. Exclusion Criteria: 1. When attending for the baseline visit participants should be clinically stable at the time of the visit. This is defined as…

View Full Trial on ClinicalTrials.gov ↗

Data sourced from ClinicalTrials.gov. Trial details may change — always check the primary source before clinical decisions.

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