Clinical Trial to Reconfirm the Efficacy and Safety of Cefetamet Pivoxil Treatment in Sinusitis Patients: A Double-Blind, Randomized, Parallel Designed, Multicenter, Active Comparator Study (CASIS Study)

Ear Nose Throat J. 2023 Feb;102(2):101-109. doi: 10.1177/01455613211036236. Epub 2021 Aug 24.

Abstract

Objective: To evaluate the clinical efficacy and safety of cefetamet pivoxil for the treatment of acute bacterial rhinosinusitis in Korean patients compared to treatment with cefdinir.

Methods: A prospective, multicenter, randomized double-blind, comparative study was conducted by the Departments of Otorhinolaryngology-Head and Neck Surgery at 17 hospitals or universities in the Republic of Korea from March 2017 to April 2019. A total of 309 patients were screened and 249 patients participated in the study.

Results: Treatment with cefetamet pivoxil for 2 weeks showed 82.4% clinical cure and improvement rates in patients with acute bacterial rhinosinusitis compared to 84.68% in those taking cefdinir for 2 weeks, showing that cefetamet pivoxil administered twice a day for 2 weeks was as effective as cefdinir 3 times a day for 2 weeks for the treatment of acute bacterial rhinosinusitis. The overall adverse reaction rates of both drugs were 10.56% in the cefetamet pivoxil group and 15.49% in the cefdinir group, without serious adverse events or drug reactions.

Conclusions: Cefetamet pivoxil twice a day was as efficacious and safe as cefdinir 3 times a day for the treatment of acute bacterial rhinosinusitis, which suggested that cefetamet pivoxil may be a suitable alternative to cefdinir.

Keywords: acute bacterial rhinosinusitis; cefdinir; cefetamet; comparative study; double-blinded method.

Publication types

  • Randomized Controlled Trial
  • Multicenter Study

MeSH terms

  • Bacteria
  • Cefdinir
  • Ceftizoxime* / adverse effects
  • Humans
  • Prospective Studies
  • Sinusitis* / chemically induced
  • Sinusitis* / drug therapy

Substances

  • cefetamet pivoxyl
  • Cefdinir
  • Ceftizoxime