El. Goldblatt et al., Topical ofloxacin versus systemic amoxicillin/clavulanate in purulent otorrhea in children with tympanostomy tubes, INT J PED O, 46(1-2), 1998, pp. 91-101
Citations number
14
Categorie Soggetti
Otolaryngology
Journal title
INTERNATIONAL JOURNAL OF PEDIATRIC OTORHINOLARYNGOLOGY
Acute otitis media (AOM) in children with tympanostomy tubes in place typic
ally presents with otorrhea (draining ear). Because therapy is not standard
ized, various topical and systemic antibiotics of unproven efficacy and saf
ety have been used in this indication. This study compared the safety and e
fficacy of ofloxacin otic solution, 0.3% (OFLX) with that of Augmentin(R) o
ral suspension (AUG) in pediatric subjects 1-12 years of age with tympanost
omy tubes and acute purulent otorrhea. Subjects were randomized to receive
10d of OFLX, 0.25 mi topically bid, or of AUG, 40 mg/kg per day. Audiometry
was performed in subjects greater than or equal to 4 years of age. Overall
cure rate for clinically evaluable subjects was 76% with OFLX (n = 140) an
d 69% with AUG (n = 146; P = 0.169). Overall eradication rates for OFLX and
AUG were similar for Streptococcus pneumoniae, Haemophilus influenzae and
Moraxella catarrhalis and were superior with OFLX for Staphylococcus aureus
and Pseudomonas aeruginosa (P < 0.05 for both). OFLX had a greater overall
pathogen eradication rate (96% vs. 67%; P < 0.001). Treatment-related adve
rse event rates were 31% for AUG and 6% for OFLX (P < 0.001). Neither treat
ment significantly altered hearing acuity. Topical ofloxacin 0.3% otic solu
tion 0.25:mi bid was as effective and better tolerated than systemic therap
y with Augmentin(R) oral suspension 40 mg/kg per day in treating AOM in chi
ldren with tympanostomy tubes. (C) 1998 Published by Elsevier Science Irela
nd Ltd. All rights reserved.