Cipro Combo Effective in Pediatric Middle Ear Infection

By David Douglas

December 29, 2016

NEW YORK (Reuters Health) - In children with acute otitis media with tympanostomy tubes (AOMT), topical ciprofloxacin plus fluocinolone acetonide (Otovel, Salvat) is more effective than either agent alone, according to results from two randomized trials.

As Dr. Zorik Spektor told Reuters Health by email, "The results demonstrated greater effectiveness of the combination versus each of its components for the treatment of ear infections with a draining ear after placement of tympanostomy tubes. Clinicians now have another effective treatment of this condition supplied in the form of individually packaged single doses, administered twice per day for a week."

In a December 22 online paper in JAMA Otolaryngology-Head & Neck Surgery, Dr. Spektor of the Center for Pediatric ENT-Head and Neck Surgery, Boynton Beach, Florida and colleagues report on two identical randomized trials in which a total of 662 children (median age, 2.5 years) received either ciprofloxacin plus fluocinolone, ciprofloxacin alone, or fluocinolone alone twice daily for 7 days.

The median time to cessation of otorrhea was 4.23 days in the combination group and 6.95 days in the ciprofloxacin group. This outcome was not estimable in the fluocinolone group because those with cessation of otorrhea were outnumbered by those who discontinued prematurely or took rescue medication.

However, clinical cure was achieved in a greater percentage of children in the ciprofloxacin plus fluocinolone group than in the other study groups.

Moreover, results obtained at the end of treatment and test-of-cure visits revealed statistically significant differences between ciprofloxacin plus fluocinolone compared with either treatment alone.

In addition, the frequency of adverse events associated with the treatments was less than 5% in each of the three groups, the investigators say. None were severe.

The researchers conclude that "topical treatment with ciprofloxacin in combination with fluocinolone constitutes a safe and effective treatment for children with AOMT and allows for superior levels of clinical efficacy than treatment with either component alone."

Commenting by email, otolaryngologist Dr. Eric A. Mair noted, "The combination of antibiotic and steroid resulted in resolution of bothersome otorrhea almost three days faster than antibiotic alone."

Dr. Mair of Charlotte Eye, Ear, Nose, and Throat Associates, North Carolina, told Reuters Health that this was a well designed study and the first major topical ear drop study to investigate both these single agents and their combination.

However, he added, "The authors did not address how ciprofloxacin in combination with fluocinolone, a weaker short-acting anti-inflammatory steroid, could possibly outperform ciprofloxacin plus a stronger long-acting steroid like dexamethasone."

The trials were sponsored by Laboratorios SALVAT SA. Dr Spektor has received personal fees and other support from SALVAT as have other authors.


JAMA Otolaryngol Head Neck Surg 2016.