As per the Treatment Guidelines by ICMR, 2019, Ciprofloxacin is the empirical antibiotic recommended in prostatitis, due to its broad-spectrum antibacterial activity, good bioavailability, and high concentrations in the prostatic tissue. Globally, as well as in India, high rates of quinolone resistance (>20%) are being reported. Antibiotic options for prostatitis are limited as only a few antibiotics are able to achieve high concentrations in the prostate. Therefore, the treatment of chronic bacterial prostatitis is an unmet medical need.

Fosfomycin is an old antibiotic, discovered in 1969 and approved as an oral and intravenous formulation. It is a broad-spectrum antibiotic achieving high concentrations in the prostate and urinary tract. Sensitivity of Escherichia coli (E. coli) the main causative organism for prostatitis to fosfomycin remains high. Further, as per the Indian Council of Medical Research’s (ICMR) Antimicrobial Resistance Research and Surveillance Network, Annual Report, 2020, sensitivity of Enterococcus faecalis (E. faecalis), another key organism in prostatitis to fosfomycin has increased in the recent years. There are several studies and case reports in the published literature that have demonstrated the efficacy of fosfomycin to achieve microbiological and clinical cure in the patients of chronic bacterial prostatitis and due to the widespread resistance to the fluoroquinolones, co-trimoxazole and tetracyclines, use of fosfomycin in prostatitis in increasing in India.

Currently, the indication of prostatitis is not approved for fosfomycin. Therefore, this comparative clinical trial of fosfomycin with ciprofloxacin is planned to evaluate the efficacy and safety of oral fosfomycin in CBP.