Clinical Research Directory
Browse clinical research sites, groups, and studies.
Comparison of Two Antibiotic Regimens for the Treatment of Early Airways Infection With PA in Adults With Bronchiectasis
Sponsor: Centre Hospitalier Intercommunal Creteil
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.
Official title: 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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
196
Start Date
2024-09-15
Completion Date
2028-09-15
Last Updated
2025-07-17
Healthy Volunteers
No
Conditions
Interventions
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).
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).
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