Efficacy of ofloxacin and other otic preparations for acute otitis media in patients with tympanostomy tubes.

Otorrhea occurs in 21 to 50% of all children with tympanostomy tubes in the United States. More than 1 million children annually undergo tubomyringotomy, constituting placement of more than 2 million tympanostomy tubes each year. The organisms typically responsible for otorrhea are the same as those that cause otitis media in very young children, including Streptococcus pneumonia, Haemophilus influenzae and Moraxella catarrhalis. Drainage from tympanostomy tubes in older children involves organisms that colonize the external auditory canal, the most common being Pseudomonas aeruginosa and Staphylococcus aureus. Ofloxacin (Floxin otic), a newer fluoroquinalone antibiotic, has several advantages over other agents available for the treatment of otorrhea caused by acute otitis media in patients with tympanostomy tubes. The twice daily dosing regimen encourages better patient adherence to therapy, which is likely to improve treatment efficacy. Ofloxacin has not been associated with ototoxicity in animal models or in children participating in the clinical trials. It provides coverages for a wide range of pathogens, including Pseudomonas sp., and is indicated for use in children > or =1 year old and currently approved for patients > or =12 years with chronic suppurative otitis media. Ofloxacin applied topically in children with tympanostomy tubes in place and purulent otorrhea is as efficacious as oral amoxicillin/clavulanate (Augmentin) therapy. Other currently available therapeutic options are discussed.

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 typically presents with otorrhea (draining ear). Because therapy is not standardized, various topical and systemic antibiotics of unproven efficacy and safety have been used in this indication. This study compared the safety and efficacy of ofloxacin otic solution, 0.3% (OFLX) with that of Augmentin oral suspension (AUG) in pediatric subjects 1-12 years of age with tympanostomy tubes and acute purulent otorrhea. Subjects were randomized to receive 10d of OFLX, 0.25 ml topically bid, or of AUG, 40 mg/kg per day. Audiometry was performed in subjects > or =4 years of age. Overall cure rate for clinically evaluable subjects was 76% with OFLX (n = 140) and 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 adverse event rates were 31% for AUG and 6% for OFLX (P<0.001). Neither treatment significantly altered hearing acuity. Topical ofloxacin 0.3% otic solution 0.25 ml bid was as effective and better tolerated than systemic therapy with Augmentin oral suspension 40 mg/kg per day in treating AOM in children with tympanostomy tubes.