CC-BY-NC-ND 4.0 · Int Arch Otorhinolaryngol 2017; 21(04): 329-335
DOI: 10.1055/s-0037-1598648
Original Research
Thieme Revinter Publicações Ltda Rio de Janeiro, Brazil

Evaluation of the Efficacy and Tolerability of Oral Ciprofloxacin used in the Comprehensive Treatment of External Bacterial Otitis: An Observational Prospective Study

Alexander Vladimirovich Gurov1, Andrey Ivanovich Kriukov1, Vera Yakovlevna Kunelskaya1, Galina Nikolaevna Isotova1, Georgiy Borisovich Shadrin1, Yuliya Vladislavovna Luchsheva1, Vladislav Olegovich Yakimov1, Amit Garg2, Shyam Prasad Akku2, Namita Gupta3
  • 1The Sverzhevskiy Otorhinolaryngology Healthcare Research Institute, Moscow Department of Healthcare, Moscow, Russian Federation
  • 2Emerging Markets, Global Medical Affairs, Dr. Reddy's Laboratories Ltd., Hyderabad, Telangana, India
  • 3Global Medical Affairs, Dr. Reddy's Laboratories Ltd., Hyderabad, Telangana, India
Further Information

Publication History

04 August 2016

28 November 2016

Publication Date:
17 February 2017 (eFirst)


Introduction Otitis Externa is common ear infection with a prevalence of 1%.

Objective The objective of this study is to evaluate the clinical and microbiological efficacy and safety profile with oral ciprofloxacin in the external bacterial otitis (EBO) management.

Methods This is a prospective observational study conducted with EBO outpatients referred to the otorhinolaryngology center in Moscow between March and August 2013. Our study included patients from two cohorts, acute external bacterial otitis (AEBO) - Group 1 - and exacerbation of chronic otitis externa (CEBO) - Group 2. We administered Ciprofloxacin 500 mg twice daily with standard topical EBO treatment for up to 10 days. Patients underwent evaluation on study visit days 1, 3, 5, and 10 for the severity. Bacteriological examination of ear canal cultures took place on Day 1 and Day 10.

Results We collected data from 60 EBO outpatients (AEBO: N = 30 and CEBO: N = 30). Swimming was the major risk factor associated with the disease in addition to the most common pathogenic organisms - Staphylococcus aureus and Pseudomonas aeruginosa. was We attained complete resolution of the inflammatory process in 28 (93%) and 27 (90%) patients in the AEBO and CEBO group, respectively. We confirmed this by microbiological test with almost complete eradication of the causative organisms. Overall, we observed good positive dynamics of ear canal with no major side effects.

Conclusion We found that Ciprofloxacin 500 mg, when administered orally twice daily for 7 to 10 days in otitis externa patients is clinically and microbiologically effective and comparatively safer than other antimicrobials.


This trial is registered with, number NCT02140073.