Ciprofloxacin plus fluocinolone acetonide, combo effective for treating Acute Otitis External

USA: Ciprofloxacin 0.3%, plus fluocinolone acetonide 0.025%, the otic solution is efficient and safe in treating acute otitis external (AOE), states an article published in the JAMA Network Open.

Otitis externa, an inflammatory condition (acute or chronic) of the external auditory canal is common worldwide with a prevalence of 10%. Patients with Acute Otitis External (AOE) present with otalgia, tenderness, diffuse ear canal oedema, and otorrhea. If untreated, the infection can spread to nearby tissue and bone. Topical antibiotics (mainly ciprofloxacin)  are the preferred first-line treatment because they efficiently reach the infection site, present low adverse events and minimize the development of antibiotic resistance. In AOE, the addition of corticosteroids to ototopical antibiotic treatment is believed to enhance the resolution of the inflammatory response and improve associated symptoms. Fluocinolone acetonide is a corticosteroid with anti-inflammatory, antipruritic, and vasoconstrictive properties.

Chu L, Benchmark Research, Austin, Texas and colleagues conducted a study to evaluate the superiority of ciprofloxacin, 0.3%, plus fluocinolone acetonide, 0.025%, otic solution vs ciprofloxacin and fluocinolone acetonide alone to treat AOE.

Researchers enrolled 493 patients aged 6 months or older with AOE of less than 21 days duration for the study. Patients were randomly assigned to receive ciprofloxacin plus fluocinolone(n-197), ciprofloxacin(n-196), or fluocinolone(n-100 ) twice daily for 7 days and were evaluated on day 1 (visit 1; baseline), days 3 to 4 (visit 2; conducted via telephone), days 8 to 10 (visit 3; end of treatment), and days 15 to 17 (visit 4; test of cure). The primary outcome was a therapeutic cure (clinical and microbiological) at the end of the treatment period. The principal secondary endpoint was the time to end ear pain.

Key findings of the study,

• Therapeutic cure in the population with ciprofloxacin plus fluocinolone was statistically comparable to that of ciprofloxacin(P = 0.30) and fluocinolone(P =0 .06) at visit 3 and significantly superior to ciprofloxacin at visit 4 (P =0 .04).

• A statistically faster resolution of otalgia was achieved among patients treated with ciprofloxacin plus fluocinolone vs ciprofloxacin ( P =0 .002) or fluocinolone (P <0 .001).

• Ciprofloxacin plus fluocinolone demonstrated statistical superiority in sustained microbiological response vs ciprofloxacin (P =0 .04) and fluocinolone (P =0 .01) and the microbiological outcome vs fluocinolone by visit 3 (P =0 .01) and ciprofloxacin by visit 4 (P =0 .02).

• Fifteen mild or moderate. adverse events related to study medications were registered.

The authors conclude that otic solution containing ciprofloxacin, 0.3%, plus fluocinolone acetonide, 0.025%, was efficacious and safe in treating AOE but in the main study endpoint of therapeutic cure, it did not demonstrate superiority to the use of ciprofloxacin and fluocinolone acetonide alone.

The findings suggest that to manage patients with AOE, concerning both the bacterial infection and the typical disease signs and symptoms, a combination of the antibiotic (ciprofloxacin) and the corticosteroid (fluocinolone acetonide) is beneficial, the authors wrote.

Chu L, Acosta AM, Aazami H, et al. Efficacy and Safety of Ciprofloxacin Plus Fluocinolone Acetonide Among Patients With Acute Otitis Externa: A Randomized Clinical Trial. JAMA Netw Open. 2022;5(7):e2221699. doi:10.1001/jamanetworkopen.2022.21699