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Treatment of chronic suppurative otitis media with topical ciprofloxacin
J E Dohar1, C M Alper, E A Rose
1Department of Pediatric Otolaryngology, University of Pittsburgh School of Medicine and Children's Hospital of Pittsburgh, Pennsylvania 15213, USA.
Abstract:
To date, only ofloxacin has been approved by the US Food and Drug Administration for treatment of ears with a nonintact tympanic membrane. The purpose of this study was to determine the safety and efficacy of topical ciprofloxacin hydrochloride in the treatment of experimental chronic suppurative otitis media caused by Pseudomonas aeruginosa infection in cynomolgus monkeys. Forty adult cynomolgus monkeys were divided into 4 equal groups, and their ears were challenged with P aeruginosa, drained for 3 weeks, then treated twice daily for 4 weeks with 1 of 4 randomly assigned agents: 1) ciprofloxacin, 2) saline, 3) Cortisporin, or 4) vehicle. The animals were followed up with auditory brain stem response testing, culture, otoscopy, and histopathology. Both ciprofloxacin and Cortisporin treatment resulted in a significantly more rapid rate of clearance of P aeruginosa as compared to treatment with saline (100% versus 20%). Eradication was not associated with resolution of otorrhea after a 4-week period of treatment. There were no significant changes in auditory brain stem response wave latencies for any of the treatment groups. Histopathologic data revealed that there was no statistically significant difference in the amount of outer hair cell loss for the ciprofloxacin group as compared to the control ear and other treatment groups. We conclude, therefore, that topical ciprofloxacin is not ototoxic and is effective in sterilizing the otorrhea, but does not promote resolution of the drainage, in this animal model.
Insights
Topical ciprofloxacin effectively sterilized Pseudomonas aeruginosa infections in a chronic otitis media model. However, it did not resolve ear drainage, indicating a need for further research in otitis media treatment.
Area of Science:
- Otolaryngology
- Infectious Diseases
- Pharmacology
Background:
- Ofloxacin is the only FDA-approved treatment for otitis media with nonintact tympanic membranes.
- Chronic suppurative otitis media (CSOM) caused by Pseudomonas aeruginosa presents a significant treatment challenge.
Purpose of the Study:
- To evaluate the safety and efficacy of topical ciprofloxacin hydrochloride for experimental CSOM in cynomolgus monkeys.
- To compare ciprofloxacin's effectiveness against P. aeruginosa with saline, Cortisporin, and vehicle controls.
Main Methods:
- Forty cynomolgus monkeys with P. aeruginosa-induced CSOM were treated with ciprofloxacin, saline, Cortisporin, or vehicle for 4 weeks.
- Evaluations included auditory brain stem response (ABR) testing, cultures, otoscopy, and histopathology.
Main Results:
- Ciprofloxacin and Cortisporin significantly accelerated P. aeruginosa clearance compared to saline (100% vs. 20%).
- Bacterial eradication did not correlate with resolution of otorrhea after 4 weeks.
- No significant ototoxicity was observed with ciprofloxacin, with no difference in outer hair cell loss compared to controls.
Conclusions:
- Topical ciprofloxacin is non-ototoxic and effective in sterilizing otorrhea in this CSOM animal model.
- Ciprofloxacin's efficacy in eradicating P. aeruginosa is demonstrated, but it does not resolve ear drainage.