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Br J Ophthalmol. 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.

Author information

1
Service d'Ophtalmologie, Centre Saint Victor, CHU d'Amiens, Université Picardie Jules Verne, Amiens, France INSERM UMRS968, Institut de la Vision, Université Paris 6, Paris, France.
2
Service d'Ophtalmologie, Hôpital Gabriel Montpied, CHU Clermont-Ferrand, Clermont-Ferrand, France IGCNC-EA7282-UMR6284 ISIT, UFR Médecine, Université d'Auvergne, Clermont Université, Clermont-Ferrand, France.
3
University Eye Clinic, IRCCS Policlinico San Matteo Foundation, Pavia, Italy.
4
Service d'Ophtalmologie, Hôpital Régional de la Madhia, CHU Tahar Sfar de Mahdia, Mahdia, Tunisie.
5
Cabinet d'Ophtalmologie, Blida, Algérie.
6
Ophthalmology Department, University Emergency Hospital, Bucharest, Romania.
7
Service d'Ophtalmologie, CHU de Strasbourg, Strasbourg, France.
8
Service d'Ophtalmologie, CHU Mustapha, Alger, Algérie.
9
Augenarztpraxis, Dossenheimer Landstr, Heidelberg, Germany.
10
Ophthalmology Department, The Children's Memorial Health Institute, Warsaw, Poland.
11
Faculty of Medicine, Department of Ophthalmology, Centro Hospitalar Universitário Coimbra, University of Coimbra, Coimbra, Portugal.
12
Laboratoires THÉA, Clermont-Ferrand, France.
13
Service d'Ophtalmologie, Hôpital Gabriel Montpied, CHU Clermont-Ferrand, Clermont-Ferrand, France EA 7281 R2D2, Laboratoire de Biochimie Médicale, Faculté de Médecine, Université d'Auvergne, Clermont-Ferrand, France.

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

PMID:
24526744
PMCID:
PMC4033170
DOI:
10.1136/bjophthalmol-2013-303888
[Indexed for MEDLINE]
Free PMC Article
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