Topical ofloxacin treatment of otorrhea in children with tympanostomy tubes

Objective: To determine the safety and efficacy of ofloxacin otic solution in the treatment of acute otorrhea in children with tympanostomy tubes. Design: Multicenter study with an open-label, prospective ofloxacin arm and retrospective historical and current practice arms. Setting: Ear, nose, and throat pediatric and general practice clinics and o ffice-based practices. Subjects: Children younger than 12 years with acute purulent otorrhea of pr esumed bacterial origin and tympanostomy tubes. Intervention: Instillation of 0.3% ofloxacin, 0.25 mL, twice daily for 10 d ays in the prospective arm; review of medical records in the retrospective arms. Main Outcome Measures: The primary index of clinical efficacy was absence ( cure) or presence (failure) of otorrhea at 10 to 14 days after therapy. The primary index of microbiologic efficacy (in the ofloxacin arm only) was er adication of pathogens isolated at baseline. Safety was evaluated in the of loxacin arm only. Results: Significantly more clinically evaluable ofloxacin-treated subjects were cured (84.4%; 119/141) than were historical practice subjects (64.2%; 140/218) (P less than or equal to.001) or current practice subjects (70%; 33/47) (P less than or equal to.03). All baseline pathogens were eradicated in 103 (96.3%) of 107 microbiologically evaluable ofloxacin subjects. Adve rse events considered "possibly" or "probably" treatment related occurred i n 29 (12.8%) of 226 ofloxacin-treated subjects. Conclusion: Ofloxacin is safe and significantly more effective than treatme nts used in historical or current practice for acute purulent otorrhea in c hildren with tympanostomy tubes.