Randomized prospective comparison of fosfomycin and cefotiam for prevention of postoperative infection following urological surgery.

ABSTRACT

A randomized study design was used to compare the efficacy of cefotiam (CTM) and fosfomycin (FOM) for preventing infection associated with urologic surgery. Of 207 patients initially enrolled, data from 202 were evaluated for drug safety, and data from 195 were evaluated for efficacy (115 transurethral endoscopic surgeries, 20 clean surgeries, 54 clean-contaminated surgeries, and 6 contaminated surgeries). FOM (2 g/dose) or CTM (1 g/dose), assigned by random ballot, was drip infused starting 30 min before surgery. The same drug was drip infused twice daily (3 days) after surgery. Drugs were rated ineffective when infection was diagnosed or suspected during the first 14 days after surgery, and effective when postoperative infection was clearly prevented. Response rates were 90.8% (177/195) overall, 90.5% (86/95) for FOM, and 91.0% (91/100) for CTM. The response rate difference between FOM and CTM was -0.5% (95% confidence interval [CI] -8.6% to 7.7%), which ruled out a minimum 10% inferiority of FOM to CTM. FOM and CTM response rates were 92.9% and 94.9%, respectively, in transurethral surgery patients, and 87.2% and 85.4% in open-surgery patients. Open surgeries consisted of clean surgery, clean-contaminated surgery, and contaminated surgery, of which the response rates for FOM and CTM were 100% and 84.6%; 89.7% and 96.0%; and 33% and 0%, respectively. Surgical-site infection rates in open surgeries were 0% for FOM and 4.9% for CTM, with no statistically significant difference. These data show that CTM and FOM are similarly effective in preventing infection following a wide range of urologic surgeries.