Efficacy and safety of azithromycin 1.5% eye drops in paediatric population with purulent bacterial conjunctivitis.
Br J Ophthalmol
; 98(6): 739-45, 2014 Jun.
Article
em En
| MEDLINE
| ID: mdl-24526744
ABSTRACT
OBJECTIVE:
To determine the efficacy and safety of azithromycin 1.5% eye drops in a paediatric population with purulent bacterial conjunctivitis. PATIENTS ANDMETHODS:
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 3â days) or tobramycin 0.3% eye drops (every 2â h for 2â days, then four times daily for 5â 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 3.2â years; range 1â day-17â 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 24â 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.Palavras-chave
Texto completo:
1
Bases de dados:
MEDLINE
Assunto principal:
Infecções Oculares Bacterianas
/
Conjuntivite Bacteriana
/
Azitromicina
/
Antibacterianos
Tipo de estudo:
Clinical_trials
Limite:
Adolescent
/
Child
/
Child, preschool
/
Female
/
Humans
/
Infant
/
Male
/
Newborn
Idioma:
En
Revista:
Br J Ophthalmol
Ano de publicação:
2014
Tipo de documento:
Article
País de afiliação:
França