PRIME Trial - Primary Respiratory Infection and Microbiological Eradication Trial

Ki vehet részt

• Adults aged >18 years
• Diagnosis of NCFB based on clinical symptoms and HRCT imaging within the last five years
• Primary PA infection, identified by isolation of PA from a respiratory sample, meeting one of the following criteria: -First isolation: The patient has never had a positive culture for PA from a respiratory sample* before. -PA persistence: The patient had a first isolation of PA from a respiratory sample during an exacerbation, followed by systemic antibiotic treatment (oral or intravenous), with PA persisting in a respiratory sample four weeks after the completion of treatment. -New isolation: The patient had a prior positive culture for PA from a respiratory sample, with at least three negative cultures for PA over the preceding year (spaced at least one month apart) without chronic antipseudomonal treatment during this period. * Respiratory sample: sputum or bronchoscopic sample obtained during routine clinical practice
• Clinically stable at the time of inclusion: no exacerbations in the past month and no need for intravenous medications or hospitalization
• Signed informed consent

Ki nem vehet részt

• Patients with contraindications to the study medications (ciprofloxacin or colistin)
• Patients receiving chronic antibiotic therapy
• Infection with PA resistant to the treatments under investigation or infection with other bacteria
• Patients with a history of intolerance to inhaled treatment via nebulization
• Patients with cystic fibrosis, uncontrolled asthma, tuberculosis, or immunosuppression
• Patients with uncontrolled systemic diseases within the last 3 months
• Women of childbearing age not using a highly effective contraceptive method
• Patients participating in other clinical trials
• Refusal to participate
• Patients with a glomerular filtration rate < 30 ml/min/1.73 m²
• Pregnant or breastfeeding women