LOS ANGELES — Topical ciprofloxacin/dexamethasone is effective in treating acute otitis media with otorrhea through tympanostomy tubes, Dr. Joseph E. Dohar wrote in a poster presentation at the annual meeting of the American Academy of Otolaryngology-Head and Neck Surgery Foundation.
Topical ciprofloxacin 0.3% and dexamethasone 0.1%, marketed as Ciprodex sterile otic suspension, produced more clinical cures, earlier cessation of otorrhea, and caused fewer side effects than oral amoxicillin/clavulanate potassium (Augmentin), wrote Dr. Dohar, an otolaryngologist at the Children's Hospital of Pittsburgh. Alcon Laboratories, maker of Ciprodex, sponsored the study.
Dr. Dohar is a clinical investigator, consultant, and speaker for the company.
“My personal experience has been extremely favorable when using topical ciprofloxacin/dexamethasone,” Dr. Dohar said in an interview.
“The topical combination is superior to systemic antibiotics, due to better cure rates, more effective killing of bacteria, less treatment-related resistance, and far fewer side effects.”
In this observer-masked, prospective multicenter trial, 80 children aged 6 months to 8 years (mean 2 years) with acute otitis media and otorrhea were randomized to treatment with either topical ciprofloxacin/dexamethasone drops or a 5-mL oral suspension of 600 mg amoxicillin/42.9 mg clavulanate potassium.
The median time to cessation of otorrhea was 4 days in the ciprofloxacin/dexamethasone group and 7 days in the amoxicillin/clavulanic acid group.
Ciprofloxacin/dexamethasone also had fewer side effects.
Of the children receiving the drops, 5% complained of ear pain, compared with 20% of children taking the suspension had diarrhea.
The treatment failure rate was 17% for ciprofloxacin/dexamethasone and 41% for amoxicillin/clavulanic acid.
These results are impressive, Dr. Dohar said in an interview.
“The study design was meticulous, and a relatively small sample size resulted in such a positive outcome. It is rare in the modern era of anti-infectives to be able to demonstrate superiority.”