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Randomized Controlled Trial
. 2014 Jun;98(6):739-45.
doi: 10.1136/bjophthalmol-2013-303888. Epub 2014 Feb 13.

Efficacy and safety of azithromycin 1.5% eye drops in paediatric population with purulent bacterial conjunctivitis

Dominique Bremond-Gignac  1 , Hachemi Nezzar  2 , Paolo Emilio Bianchi  3 , Riadh Messaoud  4 , Sihem Lazreg  5 , Liliana Voinea  6 , Claude Speeg-Schatz  7 , Dahbia Hartani  8 , Thomas Kaercher  9 , Beata Kocyla-Karczmarewicz  10 , Joaquim Murta  11 , Laurent Delval  12 , Didier Renault  12 , Frédéric Chiambaretta  13 ; AZI Study Group
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Free PMC article
Randomized Controlled Trial

Efficacy and safety of azithromycin 1.5% eye drops in paediatric population with purulent bacterial conjunctivitis

Dominique Bremond-Gignac et al. Br J Ophthalmol. 2014 Jun.
Free PMC article

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.

Keywords: Child Health (paediatrics); Conjunctiva; Infection.

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Figures

Figure 1
Figure 1
Study flow chart.
Figure 2
Figure 2
Clinical cure and bacteriological resolution in the worse eye in patients aged <24 months (microbiologically positive full analysis set, N=112).
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