A Double Blind Clinical Study of Fosfomycin (FOM) Otic Solution for the Treatment of Chronic Suppurative Otitis Media and its Acute Exacerbations

Abstract

In order to evaluate the clinical efficacy and safety of 3 % Fosfomycin (FOM) otic solution on suppurative otitis media, a double blind study was carried out comparing topical administration of FOM otic solution or placebo solution to patients with chronic suppurative otitis media and its acute exacerbations. Cephalexin was orally administered as a basic treatment. Clinical efficacy was analyzed in 247 patients (126 administered FOM, 121 administered placebo). Side effects were analyzed in 259 patients (129 administered FOM, 130 administered placebo) and clinical usefulness was analyzed in 248 patients (126 administered FOM, 122 administered placebo). The following results were obtained: 1) The overall clinical effectiveness rate judged by chief physicians was 66.7 % for the FOM group and 43.8 % for the placebo group. These results are significantly different. 2) The overall clinical offectiveness rate judged by a committee was significantly different for the two treatments (64.3 % for the FOM group and 40.5 % for the placebo group). 3) As to improvement rate of subjective and objective symptoms, a significant higher rate was obtained with the FOM group than with the placebo group. 4) The bacteriological elimination rate of causative organisms in all cases was 69.2 % treated with FOM and 46.7 % treated with placebo; the difference was significant. 5) Some side effects and adverse reactions were observed in 2 patients (1.6 %) in FOM group and in 2 patients (1.5 %) in the placebo group. Therefore, no singificant difference was observed in the incidence of adverse reactions. All adverse reactions observed were transient and not severe. 6) The overall clinical usefulness rate judged by the chief physicians was significantly greater for the FOM group (67.5 %) than for the placebo group (44.3 %). From the above results it was concluded that 3 % FOM otic solution possessed an excellent antibacterial activity, and is a efficient and safe topical preparation for the treatment of suppurative otitis media.