Ertapenem prophylaxis of surgical site infections in elective colorectal surgery in China: a multicentre, randomized, double-blind, active-controlled study

Received 20 February 2014; returned 15 March 2014; revised 2 July 2014; accepted 12 July 2014Objectives:Our purpose was to evaluate ertapenem versus ceftriaxone/metronidazole for prophylaxis of surgicalsite infections (SSIs) following elective colorectal surgery in Chinese adult patients.Methods:EligibleChineseadultsaged18–80 yearsscheduledtoundergoelectivecolorectalsurgerybylaparotomywere randomized to receive a 30 min infusion of 1 g of ertapenem/metronidazole placebo or 2 g of ceftriaxone/500 mg of metronidazole within 2 h before initial incision. The study endpoint was the proportion of patientswithsuccessfulprophylaxisat4 weeksaftertreatment.Theprimaryanalysiswasbasedontheevaluablepopulation(PP population) and the pre-specified non-inferiority margin was set at 215%. ClinicalTrials.gov: NCT01254344.Results: Of 599 patients randomized, 499 (251 ertapenem and 248 ceftriaxone) were eligible for inclusion inthe PP population. The proportions of patients with successful prophylaxis in the ertapenem and ceftriaxonegroups were 90.4% (227/251) and 90.3% (224/248), respectively. The difference in the proportion of successfuloutcomes was 0.1% (95% CI 25.2%, 5.5%). Unexplained antibioticusewasthe mostfrequentreasonfor prophy-laxis failure in both groups [ertapenem 4.8% (12/251), ceftriaxone 4.4% (11/248); difference 0.3%; 95% CI 23.6,4.3]. Pathogen species isolated from SSI sources were consistent with previously conducted studies and theproduct package insert. The incidence of adverse events (AEs) was similar between the groups, with the mostcommon AE being pyrexia [ertapenem 7.6% (22/290), ceftriaxone 5.7% (17/297)].Conclusions: Ertapenem is as effective as ceftriaxone/metronidazole for SSI prophylaxis in patients undergoingelective colorectal surgery, and is well tolerated.Keywords: b-lactams, ceftriaxone, metronidazole