Actively Recruiting
Comparison of Two Antibiotic Regimens for Early Airways Infection With Pseudomonas Aeruginosa in Adults With Bronchiectasis: A Randomized Controlled Trial
Led by Centre Hospitalier Intercommunal Creteil · Updated on 2025-07-17
196
Participants Needed
18
Research Sites
182 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
Researchers are studying adults with bronchiectasis who have a recent infection of Pseudomonas aeruginosa (PA) in their airways. This infection is linked to more frequent worsening of symptoms, lower quality of life, and a higher risk of death. The study compares two antibiotic treatment plans to find out if a simpler oral and inhaled antibiotic combination works as well as a more intensive treatment involving intravenous antibiotics. This research aims to provide clearer evidence to guide how these infections should be treated for better health and economic outcomes. The study tests two treatment approaches over a 3-month period. One group receives an oral fluoroquinolone antibiotic combined with inhaled colistimethate sodium, starting with 14 days of both followed by 2.5 months of inhaled antibiotic alone. The other group gets intravenous beta-lactam antibiotic plus the same oral and inhaled antibiotics in the initial 14 days, then continues inhaled treatment alone for 2.5 months. After treatment, participants are followed for 9 more months to monitor their health and infection status, totaling 12 months from the start of therapy. Participants will have regular check-ups during and after treatment to measure how well PA is eradicated and to track any return of infection or worsening symptoms. Questionnaires will assess quality of life and treatment burden at the start, 3 months, and 12 months. Researchers will also monitor antibiotic resistance, adverse events, and healthcare costs over one year. This comprehensive follow-up helps evaluate both the medical and economic impact of the two antibiotic regimens in managing early PA airway infection in bronchiectasis.
CONDITIONS
Brief 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...
- At least 18 years of age
- Diagnosed with bronchiectasis confirmed by thoracic CT scan
- Recent isolation of Pseudomonas aeruginosa in respiratory samples within the last 3 months
- Patient is either Pseudomonas naive or free of infection for at least 1 year
- Affiliated with the French health care system
- Able to understand and sign informed consent
You will not qualify if you...
- Confirmed diagnosis of cystic fibrosis
- Pregnancy or breastfeeding
- Women of childbearing potential who refuse effective contraception or pregnancy tests
- Pseudomonas aeruginosa isolated more than 3 months but less than 12 months before randomization
- Pseudomonas aeruginosa resistant to ciprofloxacin or ceftazidime
- Severe exacerbation requiring intensive care admission
- Prior severe reaction or contraindication to study treatments
- Prior severe bronchospasm caused by nebulization
- Receiving Pseudomonas aeruginosa suppressive inhaled antibiotic therapy
- Prior eradication antibiotic treatment for Pseudomonas aeruginosa within the last year
- Antibiotic treatment active against Pseudomonas aeruginosa for more than 3 days before randomization
- Active cancer or blood cancer under treatment
- Systemic corticosteroid therapy of 20 mg/day or more for over 4 weeks
- Recent non-tuberculous mycobacterial infection
- Severe chronic kidney or liver failure
- Long-term oxygen therapy or mechanical ventilation for chronic respiratory failure (except CPAP for sleep apnea)
- Forced expiratory volume in 1 second below 25% predicted
- Participation in another interventional clinical trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 months
Participants receive one of two antibiotic regimens for early airway infection with Pseudomonas aeruginosa, including an initial 14-day phase followed by a 2.5-month maintenance phase.
Visits as needed for treatment administration and monitoring
Duration - 9 months
Participants are monitored for 9 months after completing treatment to assess infection recurrence, quality of life, and adverse events.
Follow-up visits at 3, 6, and 12 months post-treatment
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
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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