Topical ofloxacin versus systemic amoxicillin/clavulanate in purulent otorrhea in children with tympanostomy tubes

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.