Actively Recruiting

Phase 2
Age: 18Years +
All Genders
ID06368804

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

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

Follow-up

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

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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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