Inhaled colistimethate sodium in adult bronchiectasis patients with new asymptomatic Pseudomonas aeruginosa infection– an open-label, proof of concept- randomized controlled trial (ERADICATE)

<bold>Background:</bold> Chronic bacterial infections with <italic>Pseudomonas aeruginosa</italic> (PA) have a negative impact on morbidity and mortality in bronchiectasis. Despite a lack of evidence, guidelines recommend early eradication. <bold>Study design:</bold> ERADICATE is a multicentric open-label, proof-of-concept randomized controlled trial. 66 patients with new detection of PA in sputum will be randomized in a 2:1 ratio to either inhalation of colistimethate sodium (colistin) 2 million I.U. t.i.d. for 28 days, or continuation of standard of care without receiving an eradication attempt. Both groups receive a follow-up of 28 weeks after randomization. <bold>Objectives and end-points:</bold> Primary objective is to evaluate the efficacy of colistin for 28 days versus standard of care on sputum culture negativity for PA 28 weeks after randomization. Secondary endpoints are to evaluate safety of colistin and effects on exacerbations, lung function, quality of life and microbiological aspects. <bold>Key inclusion and exclusion criteria:</bold> The trial will enroll patients ≥18 years with CT-confirmed diagnosis of bronchiectasis and new or first-time detection of PA in sputum during stable state. Key exclusion criteria are a diagnosis of cystic fibrosis, known prior infection with PA within the last 5 years or treatment with PA-active antibiotics after new sputum detection. <bold>Conclusion:</bold> This study aims to evaluate the efficacy and safety of eradication therapy with inhaled colistin adults with bronchiectasis and new detection of PA in sputum. So far, the study is ongoing and has recruited 15 patients.