Phase 2 Cystic Fibrosis Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• Adults aged 18 or older
• People who have been diagnosed with bronchiectasis (a lung condition) confirmed by a chest CT scan
• People who have had a recent respiratory sample (such as sputum) test positive for a bacteria called Pseudomonas aeruginosa (PA) within the last 3 months, with the most recent positive sample taken no more than 3 weeks before joining the trial
• People who have either never had a PA infection before, or who have been free of PA infection for at least 1 year (confirmed by at least two negative respiratory samples in the past year)
• People who are covered by the French healthcare system
• People who are able to understand and sign a consent form

Who may not be able to join:

• People who have a confirmed diagnosis of cystic fibrosis
• People who are pregnant or breastfeeding
• Women who could become pregnant and who are unwilling to use effective contraception (hormonal or physical barrier methods) for 3 months and/or are unwilling to have pregnancy tests at the start of the trial, at 1 month, and at 3 months
• People whose PA-positive respiratory sample was taken between 3 and 12 months before joining the trial (rather than within the last 3 months)
• People whose PA infection has been found to be resistant to the antibiotics ciprofloxacin or ceftazidime
• People who have had a severe flare-up of their condition requiring admission to an intensive care unit
• People who have previously had a severe or allergic reaction, or have a known medical reason to avoid any of the treatments used in this trial (ciprofloxacin, beta-lactam antibiotics, or colistimethate sodium)
• People who have previously had a severe episode of airway tightening (bronchospasm) caused by inhaled (nebulised) medication
• People already receiving long-term inhaled antibiotic treatment aimed at suppressing PA (long-term azithromycin is accepted)
• People who have received antibiotic treatment targeting PA — either as tablets/injections for 14 days or more, or as inhaled antibiotics — within the past year
• People who have received antibiotic treatment active against PA for more than 3 days immediately before joining the trial
• People currently being treated for active cancer or a blood cancer
• People taking high-dose steroid tablets (20 mg per day of prednisone or equivalent) expected to continue for more than 4 weeks
• People who have had a non-tuberculous mycobacterial lung infection, or a positive test for this type of infection, within the past year
• People with severe kidney disease (confirm with trial site for exact measurement details) or who are on long-term dialysis
• People with severe liver disease
• People who require long-term oxygen therapy or non-invasive breathing support for a chronic breathing condition, or whose lung function is severely reduced (confirm with trial site for exact measurement), excluding those using CPAP for sleep apnoea only
• People who are already taking part in another interventional clinical trial

Important: Always verify eligibility with the trial site directly before applying.