RecruitingPhase 2NCT06368804

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.


Sponsor

Centre Hospitalier Intercommunal Creteil

Enrollment

196 participants

Start Date

Sep 15, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Antibiotic bitherapy treatment and follow-up and a drug called Antibiotic monotherapy treatment and follow-up for people with bronchiectasis. The study is currently recruiting participants at 18 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAntibiotic 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).

DRUGAntibiotic 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).


Locations(18)

CHU Amiens-Picardie

Amiens, France

CHU Haut Leveque, Bordeaux

Bordeaux, France

CHRU Brest

Brest, France

CH Pontoise

Cergy-Pontoise, France

Centre hospitalier intercommunal de Créteil

Créteil, France

APHP, Henri Mondor

Créteil, France

Hôpital de la Croix Rousse, HCL, Lyon

Lyon, France

Clinique St Joseph

Marseille, France

CHU Nantes

Nantes, France

CHU H. Pasteur, Nice

Nice, France

Hôpital Pitié Salpêtrière

Paris, France

APHP, Cochin

Paris, France

APHP, Saint Louis

Paris, France

APHP, Tenon

Paris, France

Hôpital Foch, Suresnes

Suresnes, France

CHU H. Larrey, Toulouse

Toulouse, France

CH Versailles

Versailles, France

CH Villefranche s/Saône

Villefranche-sur-Saône, France

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NCT06368804


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