Around 200,000 people in the UK live with bronchiectasis, a chronic lung disease, and roughly one in three will develop a stubborn infection with *Pseudomonas aeruginosa* bacteria that accelerates lung damage. This trial will test whether aggressive antibiotic treatment—combining systemic drugs with a three-month course of inhaled antibiotics—can eradicate that first infection and cut the rate of future lung attacks (exacerbations) over two years, compared with standard care that only treats symptoms. Current guidelines recommend this eradication approach, but no robust evidence proves it works or is worth the cost. The trial will randomise 326 patients to either the eradication regimen or usual care, measuring exacerbation rates, hospitalisations, quality of life, and cost-effectiveness per exacerbation prevented and per quality-adjusted life year gained. If the treatment succeeds, it could become the new standard of care for bronchiectasis patients with a new *P. aeruginosa* infection, potentially slowing disease progression, reducing hospital admissions, and saving the NHS money. If it does not, the trial will prevent widespread adoption of an expensive, burdensome treatment that offers no benefit. Either way, the results will directly inform UK clinical guidelines.
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Research question Does Pseudomonas aeruginosa eradication treatment result in a reduced rate of exacerbations over 24 months? Is P. aeruginosa eradication cost-effective when compared with standard care? To answer these questions we will conduct a randomized controlled trial in which patients with new P. aeruginosa infection will be randomized to eradication treatment (systemic + inhaled antibiotics) compared to patients receiving only symptomatic treatment. Background Bronchiectasis is a chronic lung disease which affects 200,000 people in the UK. Infection with P. aeruginosa occurs in approximately 1/3 of patients and is associated with progression of disease and worse outcomes. When P. aeruginosa is first detected, combined treatment with systemic and inhaled antibiotics is recommended by some guidelines with the aim of preventing long term infection and preventing exacerbations. Whether this treatment is clinically and cost effective is not known. Methods Population: Adults with bronchiectasis who have a first isolate of P. aeruginosa in sputum or another respiratory sample or who have a new isolate of P. aeruginosa (defined as at least 2 consecutive respiratory samples that are negative for P. aeruginosa prior to the new isolation and no isolation of P. aeruginosa in the previous 12 months). Intervention: P. aeruginosa eradication treatment as defined by the British Thoracic Society Guidelines, consisting of systemic antibiotics (either oral or intravenous as clinically indicated) followed by inhaled anti-pseudomonal antibiotics for 3 months. Comparator: Symptomatic treatment without a formal eradication regimen. Standard care for a patient isolating P.aeruginosa who does not have symptoms of an exacerbation would be observation only. Patients will receive oral or IV antibiotics if they have symptoms of exacerbation but no inhaled antibiotics over the study period. Outcomes: The primary outcome is the rate of exacerbations over 24 months following randomization We will evaluate cost-effectiveness, presented as incremental cost per exacerbation prevented, and cost-utility analysis reported as incremental cost per quality adjusted life year (QALY) gained. Eradication, the key secondary endpoints, will be evaluated by the frequency of P. aeruginosa isolation in sputum samples taken at 12 months and 24 months indicating the success of eradication. Additional secondary outcomes will be: - Hospitalizations for severe exacerbations - Symptoms measured using the quality of life bronchiectasis questionnaire respiratory symptom domain - Quality of life using the Chronic airways assessment test (CAAT) - Symptom burden using the Bronchiectasis impact measure - Quality of life using the EQ-5D-5L - Time to reinfection - Total days of antibiotic use - Antibiotic resistance - All cause healthcare contacts - All-cause mortality - Treatment adherence - Adverse events and serious adverse events - Time to commencement of long term inhaled antibiotic treatment Sample size: 326 participants will be randomized (163 to Pseudomonas eradication treatment and 163 participants to usual care). This will provide >90% power to show a 35% reduction in the rate of exacerbations between arms. Timelines for delivery 66 months Anticipated impact and dissemination This study will answer a key clinical question in the management of bronchiectasis identified by patients and clinicians as a leading research priority. Results will inform clinical guidelines.
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