NCT06368804

Comparison of Two Antibiotic Regimens for the Treatment of Early Airways Infection With PA 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.

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 196 (estimated)
• Sponsor: Centre Hospitalier Intercommunal Creteil · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

According to current knowledge, the early combination of an oral FQ to an inhaled antibiotic could be an acceptable alternative to a systemic cotherapy. Indeed, such regimen allows avoiding IV drugs use, facilitating ambulatory management and influencing patient's quality of life and costs, and may achieve similar PA-eradication rate.

Conditions

• Bronchiectasis

Interventions

Type	Name	Description
DRUG	Antibiotic monotherapy treatment and follow-up	1. a 3-months treatment period, including: * an initial phase of 14 days, combining an oral fluoroquinolone (ciprofloxacin 750mg tw/d) with nebulized sodium colistimethate (1 Million Units tw/d) * a maintenance phase of 2.5 months: nebulized sodium colistimethate (1 MU tw/d) ; 2. a subsequent follow-up period of 9 months (i.e. until 12 months after the start of antibiotic therapy against Pseudomonas aeruginosa).
DRUG	Antibiotic bitherapy treatment and follow-up	1. a 3-months treatment period, including: * an initial phase of 14 days, combining an IV beta-lactam antibitic (ceftazidime 4 or 6g/d) and an oral fluoroquinolone (ciprofloxacin 750mg tw/d) with nebulized sodium colistimethate (1 Million Units tw/d) * a maintenance phase of 2.5 months: nebulized sodium colistimethate (1 MU tw/d) ; 2. a subsequent follow-up period of 9 months (i.e. until 12 months after the start of antibiotic therapy against Pseudomonas aeruginosa).

Timeline

• Start date: 2024-09-15
• Primary completion: 2025-03-15
• Completion: 2028-09-15
• First posted: 2024-04-16
• Last updated: 2025-07-17

Locations

18 sites across 1 country: France