Efficacy and safety of azithromycin 1.5% eye drops for purulent bacterial conjunctivitis in pediatric patients.
BACKGROUND
Purulent bacterial conjunctivitis affects all ages with high frequency in newborns and children. In a subset of 150 children included in a large study having enrolled 1043 patients, our aim was to analyze in children, the efficacy and safety of azithromycin 1.5% eye-drops in the treatment of this disease.


METHODS
This multicenter, randomized, investigator-masked, parallel-group study, included 150 children and adolescents to study safety and compare azithromycin 1.5% eye drops twice daily for 3 days and tobramycin 0.3% 1 drop every 2 hours for 2 days then 4 times daily for 5 days. Out of 150 patients included, 58 had positive cultures and were studied for efficacy. Signs and symptoms were evaluated and cultures obtained at baseline, Days 3 and 9. Primary efficacy variable was the clinical cure (score 0 for bulbar conjunctival injection and purulent discharge) at the test of cure visit (day 9).


RESULTS
Both treatments were effective with a clinical and microbiologic cure of more than 80% of children on day 9. Azithromycin therapy provided a greater bacteriologic cure on day 3 than did tobramycin (P < 0.001) and eradicated bacteria that were defined as resistant, using classical antibiogram. No adverse effects were noted on the ocular surface.


CONCLUSIONS
Azithromycin 1.5% eye drops leads to a rapid clinical and microbiological cure.
Bremond-Gignac
Dominique
D
Service d'Ophtalmologie, Centre Saint Victor, CHU d'Amiens, Bd de Beauvillé, Amiens, Université Picardie Jules Verne, France. Bremond.Dominique@chu-amiens.fr
Mariani-Kurkdjian
Patricia
P
Beresniak
Ariel
A
El Fekih
Lamia
L
Bhagat
Yasmin
Y
Pouliquen
Pascale
P
Delval
Laurent
L
Goldschmidt
Pablo
P
Bingen
Edouard
E
Cochereau
Isabelle
I
D000293:Adolescent; D000328:Adult; D000900:Anti-Bacterial Agents / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use*; D017963:Azithromycin / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use*; D001419:Bacteria / Q000302:isolation & purification; D002648:Child; D002675:Child, Preschool; D003234:Conjunctivitis, Bacterial / Q000188:drug therapy*; D005260:Female; D006801:Humans; D007231:Infant, Newborn; D008297:Male; D009883:Ophthalmic Solutions / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use*; D014031:Tobramycin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D016896:Treatment Outcome; D055815:Young Adult
D000900:Anti-Bacterial Agents; D009883:Ophthalmic Solutions; D017963:Azithromycin; D014031:Tobramycin