title: Efficacy and safety of azithromycin 1.5% eye drops in paediatric population with purulent bacterial conjunctivitis.
abstract: OBJECTIVE
  To determine the efficacy and safety of azithromycin 1.5% eye drops in a paediatric population with purulent bacterial conjunctivitis.
  
  
  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.
authors: 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.
authors: Dominique
authors: D
authors: Bremond-Gignac
authors: 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.
authors: Hachemi
authors: H
authors: Nezzar
authors: University Eye Clinic, IRCCS Policlinico San Matteo Foundation, Pavia, Italy.
authors: Paolo Emilio
authors: PE
authors: Bianchi
authors: Service d'Ophtalmologie, Hôpital Régional de la Madhia, CHU Tahar Sfar de Mahdia, Mahdia, Tunisie.
authors: Riadh
authors: R
authors: Messaoud
authors: Cabinet d'Ophtalmologie, Blida, Algérie.
authors: Sihem
authors: S
authors: Lazreg
authors: Ophthalmology Department, University Emergency Hospital, Bucharest, Romania.
authors: Liliana
authors: L
authors: Voinea
authors: Service d'Ophtalmologie, CHU de Strasbourg, Strasbourg, France.
authors: Claude
authors: C
authors: Speeg-Schatz
authors: Service d'Ophtalmologie, CHU Mustapha, Alger, Algérie.
authors: Dahbia
authors: D
authors: Hartani
authors: Augenarztpraxis, Dossenheimer Landstr, Heidelberg, Germany.
authors: Thomas
authors: T
authors: Kaercher
authors: Ophthalmology Department, The Children's Memorial Health Institute, Warsaw, Poland.
authors: Beata
authors: B
authors: Kocyla-Karczmarewicz
authors: Faculty of Medicine, Department of Ophthalmology, Centro Hospitalar Universitário Coimbra, University of Coimbra, Coimbra, Portugal.
authors: Joaquim
authors: J
authors: Murta
authors: Laboratoires THÉA, Clermont-Ferrand, France.
authors: Laurent
authors: L
authors: Delval
authors: Laboratoires THÉA, Clermont-Ferrand, France.
authors: Didier
authors: D
authors: Renault
authors: 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.
authors: Frédéric
authors: F
authors: Chiambaretta
mesh_terms: D000287:Administration, Topical; D000293:Adolescent; D000900:Anti-Bacterial Agents / Q000009:adverse effects / Q000627:therapeutic use*; D017963:Azithromycin / Q000009:adverse effects / Q000627:therapeutic use*; D001419:Bacteria / Q000302:isolation & purification; D002648:Child; D002675:Child, Preschool; D003234:Conjunctivitis, Bacterial / Q000188:drug therapy* / Q000382:microbiology; D015818:Eye Infections, Bacterial / Q000188:drug therapy* / Q000382:microbiology; D005260:Female; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D008297:Male; D009883:Ophthalmic Solutions; D014031:Tobramycin / Q000009:adverse effects / Q000627:therapeutic use; D016896:Treatment Outcome
chemical_list: D000900:Anti-Bacterial Agents; D009883:Ophthalmic Solutions; D017963:Azithromycin; D014031:Tobramycin
keywords: Child Health (paediatrics); Conjunctiva; Infection