Comparing two antibiotic treatments for early lung infections in adults with bronchiectasis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to compare the effectiveness of two different antibiotic regimens for treating early infections caused by Pseudomonas aeruginosa in adults diagnosed with bronchiectasis. Participants will be randomly assigned to receive either a monotherapy with oral fluoroquinolone or a combination therapy that includes inhaled antibiotics. The study seeks to determine which regimen is more effective in eradicating the infection while also considering the impact on patients' quality of life and healthcare costs. The trial will include adults aged 18 and older who have recently tested positive for P. aeruginosa and meet specific eligibility criteria.

Why it matters

Who can join: the full rules

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
* Pregnancy or breastfeeding
* Women of childbearing potential (after the first menstrual period and until menopause or permanent sterility (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 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.
* PA resistant to ciprofloxacin or ceftazidime
* 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)
* 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
* 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
* Severe hepatic impairment
* 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

Where it's running

• CHU Amiens-Picardie
  Amiens, France Recruiting
• CHU Haut Leveque, Bordeaux
  Bordeaux, France Recruiting
• CHRU Brest
  Brest, France Recruiting
• CH Pontoise
  Cergy-Pontoise, France Recruiting
• Centre hospitalier intercommunal de Créteil
  Créteil, France Recruiting
• APHP, Henri Mondor
  Créteil, France Recruiting

Study contacts

• Study coordinator: Camille JUNG, MD
• Email: camille.jung@chicreteil.fr
• Phone: 0157022000

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.