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ABSTRACT: Objective
To determine the efficacy and safety of azithromycin 1.5% eye drops in a paediatric population with purulent bacterial conjunctivitis.Patients and methods
This was a multicentre, international, randomised, investigator-masked study in 286 children with purulent discharge and bulbar conjunctival injection. Patients received either azithromycin 1.5% eye drops (twice daily for 3 days) or tobramycin 0.3% eye drops (every 2 h for 2 days, then four times daily for 5 days). Clinical signs were evaluated on day (D) 0, 3 and 7, and cultures on D0 and D7. The primary variable was the clinical cure (absence of bulbar conjunctival injection and discharge) on D3 in the worse eye for patients with positive cultures on D0.Results
286 patients (mean age 3.2 years; range 1 day-17 years) were included; 203 had positive cultures on D0. Azithromycin was superior to tobramycin in clinical cure rate on D3 (47.1% vs 28.7%, p=0.013) and was non-inferior to tobramycin on D7 (89.2% vs 78.2%, respectively). Azithromycin treatment eradicated causative pathogens, including resistant species, with a similar resolution rate to tobramycin (89.8% vs 87.2%, respectively). These results were confirmed in a subgroup of patients younger than 24 months old.Conclusions
Azithromycin 1.5% eye drops provided a more rapid clinical cure than tobramycin 0.3% eye drops in the treatment of purulent bacterial conjunctivitis in children, with a more convenient twice-a-day dosing regimen.
SUBMITTER: Bremond-Gignac D
PROVIDER: S-EPMC4033170 | biostudies-literature | 2014 Jun
REPOSITORIES: biostudies-literature
Bremond-Gignac Dominique D Nezzar Hachemi H Bianchi Paolo Emilio PE Messaoud Riadh R Lazreg Sihem S Voinea Liliana L Speeg-Schatz Claude C Hartani Dahbia D Kaercher Thomas T Kocyla-Karczmarewicz Beata B Murta Joaquim J Delval Laurent L Renault Didier D Chiambaretta Frédéric F
The British journal of ophthalmology 20140213 6
<h4>Objective</h4>To determine the efficacy and safety of azithromycin 1.5% eye drops in a paediatric population with purulent bacterial conjunctivitis.<h4>Patients and methods</h4>This was a multicentre, international, randomised, investigator-masked study in 286 children with purulent discharge and bulbar conjunctival injection. Patients received either azithromycin 1.5% eye drops (twice daily for 3 days) or tobramycin 0.3% eye drops (every 2 h for 2 days, then four times daily for 5 days). Cl ...[more]