Objectives/hypothesis: To compare the clinical failure rates among children with otorrhea through tympanostomy tubes treated with topical or systemic antibiotics versus topical saline.
Study design: Randomized, double-blind, controlled patient study.
Methods: A three-armed randomized clinical trial using topical ciprofloxacin or oral amoxicillin or topical saline. The primary outcome was treatment failure defined as presence of otorrhea in at least one ear after 7 days of treatment.
Results: The treatment failure rates were 23% and 70% in the group treated with topical ciprofloxacin and oral amoxicillin, respectively. Treatment failures were seen in 58% of children treated with topical saline. Thus, topical ciprofloxacin significantly reduced treatment failures compared to both oral amoxicillin and topical saline. The most frequent bacteria isolated from treatment failures in general were streptococci and Moraxella catarrhalis.
Conclusions: The significant effect of topical ciprofloxacin is probably related to a higher local concentration of antibiotics in the middle ear rather than the result of mechanical rinsing and dissolution of the bacterial load.