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

Comparison of Two Antibiotic Regimens for the Treatment of Early Airways Infection With Pseudomonas Aeruginosa in Adults With Bronchiectasis: a Non-inferiority Randomized Controlled Trial.

Phase 2 Interventional Centre Hospitalier Intercommunal Creteil · NCT06368804

This study is testing which of two antibiotic treatments works better for adults with bronchiectasis who have early lung infections caused by Pseudomonas aeruginosa.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment196 (estimated)
Ages18 Years and up
SexAll
SponsorCentre Hospitalier Intercommunal Creteil Academic / other
Drugs / interventionsprednisone
Locations18 sites (Amiens and 17 other locations)
Trial IDNCT06368804 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older with a diagnosis of bronchiectasis and recent isolation of P. aeruginosa.

Not a fit: Patients with cystic fibrosis or those who are pregnant or breastfeeding will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide clearer guidance on the most effective treatment for early P. aeruginosa infections, potentially improving patient outcomes and quality of life.

How similar studies have performed: While there is a lack of definitive studies favoring one regimen over another, the approach of comparing antibiotic treatments in this context is relevant and could provide valuable insights.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 this trial is running

Amiens and 17 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions BronchiectasisNon cystic fibrosis bronchiectasis
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.