6/28/23, 11:44 PM Ototopical ABX and CS in AOE (ciprofloxacin plus fluocinolone vs. ciprofloxacin) Pathway Feedback Search Clinical Topics Home Studies Ototopical ABX and CS in AOE (ciprofloxacin plus fluocinolone vs. ciprofloxacin) Ototopical ABX and CS in AOE (ciprofloxacin plus fluocinolone vs. ciprofloxacin) Disease Acute otitis externa Trial question Is the combination of ciprofloxacin and fluocinolone acetonide superior to ciprofloxacin in patients with acute otitis externa? Study design Multi-center Double blinded RCT Population Characteristics of study participants 50.0% female N = 393 50.0% male 393 patients (198 female, 195 male) Inclusion criteria: adults and children aged > 6 months with acute otitis externa Key exclusion criteria: previous episode of acute otitis externa within 4 weeks or > 1 episode of acute otitis externa within 6 months; tympanic membrane perforation; otitis media; malignant otitis externa Interventions N=197 ciprofloxacin plus fluocinolone acetonide (ciprofloxacin 0.3% plus fluocinolone acetonide 0.025% otic solution BID for 7 days) N=196 ciprofloxacin alone (ciprofloxacin 0.3% otic solution BID for 7 days) https://web.pathway.md/studies/reccragARbEsf2SBn 1/2 6/28/23, 11:44 PM Ototopical ABX and CS in AOE (ciprofloxacin plus fluocinolone vs. ciprofloxacin) Pathway Primary outcome Clinical and microbiological cure at day 8-10 61.2 % 61.2 53.8 45.9 % 30.6 % 15.3 % No significant difference 0.0 % Ciprofloxacin plus fluocinolone acetonide Ciprofloxacin alone No significant difference in clinical and microbiological cure at day 8-10 (61.2% vs. 53.8%; AD 7.3%, 95% CI -6.6 to 21.2) Secondary outcomes No significant difference in median number of days until cessation of ear pain (5 days vs. 5.9 days; MD -0.9, 95% CI -4.3 to 7.3) Significant increase in sustained microbiological response (91.3% vs. 81.3%; AD 9.9%, 95% CI 0.3 to 19.6) Significant increase in clinical and microbiological cure at day 15-17 (87.4% vs. 75.8%; AD 11.6%, 95% CI 0.7 to 22.4) Safety outcomes No significant difference in adverse events. Conclusion In adults and children aged > 6 months with acute otitis externa, ciprofloxacin plus fluocinolone acetonide was not superior to ciprofloxacin alone with respect to clinical and microbiological cure at day 8-10. Reference Laurence Chu, Ana M Acosta, Hessam Aazami et al. Efficacy and Safety of Ciprofloxacin Plus Fluocinolone Acetonide Among Patients With Acute Otitis Externa: A Randomized Clinical Trial. JAMA Netw Open. 2022 Jul 1;5(7):e2221699. Open reference URL https://web.pathway.md/studies/reccragARbEsf2SBn 2/2