Actively Recruiting
Comparison of Two Antibiotic Regimens for the Treatment of Early Airways Infection With PA in Adults With Bronchiectasis
Led by Centre Hospitalier Intercommunal Creteil · Updated on 2025-07-17
196
Participants Needed
18
Research Sites
208 weeks
Total Duration
On this page
Sponsors
C
Centre Hospitalier Intercommunal Creteil
Lead Sponsor
A
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsor
AI-Summary
What this Trial Is About
Chronic airways infection with Pseudomonas aeruginosa (PA) is associated with increased frequency of exacerbations, deterioration in quality of life and increased mortality in adult patients with bronchiectasis. Current guidelines suggest the prescription of an eradication antibiotic treatment for a first episode of PA infection (early PA infection). Several antibiotic regimens may be proposed, ranging from a monotherapy with oral fluoroquinolone (FQ) to an intravenous cotherapy with the addition of inhaled antibiotics that seems to improve the rate of PA eradication. As no study strictly favoured one regimen, current practices are heterogeneous and could certainly benefit from stronger evidence, with both medical and economic impact.
CONDITIONS
Official Title
Comparison of Two Antibiotic Regimens for the Treatment of Early Airways Infection With PA in Adults With Bronchiectasis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years of age or older
- Diagnosis of bronchiectasis confirmed by thoracic CT scan
- Recent detection of Pseudomonas aeruginosa in a respiratory sample within the last 3 months, with a positive sample obtained no more than 3 weeks before randomization
- Either Pseudomonas naive (never previously isolated PA) or free of Pseudomonas infection for at least 1 year, confirmed by at least two negative PA respiratory samples during the last year
- Affiliated with the French health care system
- Able to understand and sign a written informed consent form
You will not qualify if you...
- Confirmed diagnosis of cystic fibrosis
- Pregnant or breastfeeding
- Women of childbearing potential who refuse effective contraception for 3 months and/or pregnancy tests at baseline, 1 month, and 3 months after baseline
- PA detected in respiratory specimens between 3 months and 12 months before randomization
- Pseudomonas aeruginosa resistant to ciprofloxacin or ceftazidime
- Severe exacerbation requiring intensive care unit admission
- Prior severe reaction or contraindication to ciprofloxacin, beta-lactam, or colistimethate sodium
- Prior severe bronchospasm caused by nebulization
- Currently receiving inhaled antibiotic therapy suppressing PA (long-term azithromycin allowed)
- Prior antibiotic treatment for PA eradication lasting 14 days or more within the last year
- Antibiotic treatment active against PA for more than 3 days before randomization
- Active cancer or hematological malignancy under treatment
- Systemic corticosteroid therapy at or above 20 mg/day prednisone equivalent for more than 4 weeks
- Non-tuberculous mycobacterial infection or positive specimen within 1 year before inclusion
- Severe chronic kidney failure with creatinine clearance ≤ 30 mL/min/1.73m2 or on chronic hemodialysis
- Severe liver impairment
- Long-term oxygen therapy and/or noninvasive mechanical ventilation for chronic respiratory failure (except CPAP for OSA) and/or FEV1 less than 25% of predicted
- Participation in another interventional clinical trial
AI-Screening
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Trial Site Locations
Total: 18 locations
1
CHU Amiens-Picardie
Amiens, France
Actively Recruiting
2
CHU Haut Leveque, Bordeaux
Bordeaux, France
Actively Recruiting
3
CHRU Brest
Brest, France
Actively Recruiting
4
CH Pontoise
Cergy-Pontoise, France
Actively Recruiting
5
Centre hospitalier intercommunal de Créteil
Créteil, France, 94010
Actively Recruiting
6
APHP, Henri Mondor
Créteil, France
Actively Recruiting
7
Hôpital de la Croix Rousse, HCL, Lyon
Lyon, France
Not Yet Recruiting
8
Clinique St Joseph
Marseille, France, 13008
Actively Recruiting
9
CHU Nantes
Nantes, France
Actively Recruiting
10
CHU H. Pasteur, Nice
Nice, France
Not Yet Recruiting
11
Hôpital Pitié Salpêtrière
Paris, France, 75013
Actively Recruiting
12
APHP, Cochin
Paris, France
Actively Recruiting
13
APHP, Saint Louis
Paris, France
Actively Recruiting
14
APHP, Tenon
Paris, France
Actively Recruiting
15
Hôpital Foch, Suresnes
Suresnes, France
Actively Recruiting
16
CHU H. Larrey, Toulouse
Toulouse, France
Actively Recruiting
17
CH Versailles
Versailles, France
Actively Recruiting
18
CH Villefranche s/Saône
Villefranche-sur-Saône, France
Actively Recruiting
Research Team
C
Camille JUNG, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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