Comparison of Two Antibiotic Regimens for the Treatment of Early Airways Infection With PA in Adults With Bronchiectasis

Phase 1

• Conditions: Bronchiectasis; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: CTIS2023-504755-26-00
• Lead Sponsor: Centre Hospitalier Intercommunal Creteil

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-11-14
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 196

Inclusion Criteria

=18 years of age, Diagnosis of bronchiectasis on thoracic CT-scan, Recent isolation of P. aeruginosa (PA) in a respiratory sample (spontaneous or induced sputum or other lower respiratory tract sample obtained by bronchoscopy) within the last 3 months, with a PA positive respiratory sample obtained = 3 weeks before randomization, Patient either Pseudomonas naive (i.e., never previously isolated PA) or Pseudomonas free (i.e., infection-free for =1 year, proven by at least two PA negative respiratory sample during the last year), Patient affiliated with the French health care system, Able to understand and sign a written informed consent form

Exclusion Criteria

Confirmed diagnosis of cystic fibrosis, Active cancer or haematological malignancy under active therapy, Systemic corticosteroid therapy = 20 mg/d. prednisone equivalent for a predictable duration > 4 weeks, Non-tuberculous mycobacterial infection or positive non-tuberculous mycobacterial respiratory specimen within 1 year prior to inclusion, Severe chronic renal failure defined by a creatinine clearance (Cockcroft or MDRD) = 30 mL/min/1.73m2 or chronic haemodialysis, Long-term oxygen therapy and/or noninvasive mechanical ventilation for chronic respiratory insufficiency (except continuous positive airway pressure for OSA) and/or forced expiratory volume at one second (FEV1) <25% of predicted value, Patient participating to another interventional clinical trial, Pregnancy or breastfeeding, P. aeruginosa resistant to ciprofloxacin or ceftazidime, Women of childbearing potential (following menarche and until becoming post-menopausal unless permanently sterile (hysterectomy, bilateral salpingectomy and bilateral oophorectomy)) who refuse to use effective contraception (hormonal or mechanical) for 3 months and/or to undergo pregnancy tests at baseline, 1 month and 3 months after baseline, Isolation of P.Aeruginosa (PA) in a respiratory specimen (spontaneous or induced sputum or other lower respiratory tract specimen obtained by bronchoscopy) more than 3 months to 12 months prior to randomization, Severe exacerbation requiring admission to an intensive care unit (e.g. for non-invasive ventilatory support, invasive mechanical ventilation, catecholamine or any other organ supportive therapy), Acute liver failure, Prior severe reaction, hypersensitivity reaction or other contraindication to any of the treatments in study (ciprofloxacin, beta-lactam, colistimethate sodium), Prior severe bronchospasm attributed to a nebulization, Patients already receiving PA suppressive therapy with an inhaled antibiotic (long-term azithromycin therapy accepted), Prior PA-eradication antibiotic treatment (systemic antibiotic(s) active against PA for = 14 days or nebulized anti-PA antibiotic) within the last year, Antibiotic treatment active against PA (anti-PA beta-lactam antibiotic and/or FQ and/or aminoglycoside) for more than 3 days before randomisation, Protected person (pregnant woman, nursing mother, person under guardianship, minor, person deprived of liberty, person unable to give consent), Patient who has already taken part in the ANTEIPA study

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified