Ototopical ciprofloxacin and fluocinolone in AOE (ciprofloxacin plus fluocinolone vs. fluocinolone)
Trial question
Is the combination of ciprofloxacin and fluocinolone acetonide superior to fluocinolone acetonide in patients with acute otitis externa?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
52.0% female
48.0% male
N = 297
297 patients (153 female, 144 male).
Inclusion criteria: adult and pediatric patients 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=100 fluocinolone acetonide alone (fluocinolone acetonide 0.025% otic solution BID for 7 days).
Primary outcome
Clinical and microbiological cure at day 8-10
61.2%
44.4%
61.2 %
45.9 %
30.6 %
15.3 %
0.0 %
Ciprofloxacin plus fluocinolone
acetonide
Fluocinolone acetonide
alone
No significant
difference ↔
No significant difference in clinical and microbiological cure at day 8-10 (61.2% vs. 44.4%; AD 16.7%, 95% CI -0.6 to 34).
Secondary outcomes
No significant difference in median number of days until cessation of ear pain (5 days vs. 7.7 days; AD -2.7 days, 95% CI -6.7 to 9).
Significant increase in sustained microbiological response (91.3% vs. 75.6%; AD 15.7%, 95% CI 2 to 29.4).
No significant difference in clinical and microbiological cure at day 15-17 (87.4% vs. 80%; AD 7.4%, 95% CI -6 to 20.7).
Safety outcomes
No significant difference in adverse events.
Conclusion
In adult and pediatric patients aged > 6 months with acute otitis externa, ciprofloxacin plus fluocinolone acetonide was not superior to fluocinolone acetonide 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