title: Ertapenem prophylaxis of surgical site infections in elective colorectal surgery in China: a multicentre, randomized, double-blind, active-controlled study.
abstract: OBJECTIVE
  Our purpose was to evaluate ertapenem versus ceftriaxone/metronidazole for prophylaxis of surgical site infections (SSIs) following elective colorectal surgery in Chinese adult patients.
  
  
  METHODS
  Eligible Chinese adults aged 18-80 years scheduled to undergo elective colorectal surgery by laparotomy were 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 patients with successful prophylaxis at 4 weeks after treatment. The primary analysis was based on the evaluable population (PP population) and the pre-specified non-inferiority margin was set at -15%. ClinicalTrials.gov: NCT01254344.
  
  
  RESULTS
  Of 599 patients randomized, 499 (251 ertapenem and 248 ceftriaxone) were eligible for inclusion in the PP population. The proportions of patients with successful prophylaxis in the ertapenem and ceftriaxone groups were 90.4% (227/251) and 90.3% (224/248), respectively. The difference in the proportion of successful outcomes was 0.1% (95% CI -5.2%, 5.5%). Unexplained antibiotic use was the most frequent reason for prophylaxis failure in both groups [ertapenem 4.8% (12/251), ceftriaxone 4.4% (11/248); difference 0.3%; 95% CI -3.6, 4.3]. Pathogen species isolated from SSI sources were consistent with previously conducted studies and the product package insert. The incidence of adverse events (AEs) was similar between the groups, with the most common 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 undergoing elective colorectal surgery, and is well tolerated.
authors.affiliation: Department of Surgery, Peking University People's Hospital, Beijing, China lengxs2003@yahoo.com.cn.
authors.forename: Xi-sheng
authors.initials: XS
authors.lastname: Leng
authors.affiliation: Department of Surgery, Tianjin People's Hospital, Tianjin, China.
authors.forename: Yong-jie
authors.initials: YJ
authors.lastname: Zhao
authors.affiliation: Department of General Surgery, Peking Union Medical College Hospital, Beijing, China.
authors.forename: Hui-zhong
authors.initials: HZ
authors.lastname: Qiu
authors.affiliation: Department of General Surgery, Chengdu Military General Hospital, Chengdu, China.
authors.forename: Yong-kuan
authors.initials: YK
authors.lastname: Cao
authors.affiliation: Department of Surgery, Peking University People's Hospital, Beijing, China.
authors.forename: Wei-hua
authors.initials: WH
authors.lastname: Zhu
authors.affiliation: MSD China, Shanghai, China.
authors.forename: Ju-fang
authors.initials: JF
authors.lastname: Shen
authors.affiliation: Merck & Co., Inc., Whitehouse Station, NJ, USA.
authors.forename: Amanda
authors.initials: A
authors.lastname: Paschke
authors.affiliation: PAREXEL International, Shanghai, China.
authors.forename: Wei-min
authors.initials: WM
authors.lastname: Dai
authors.affiliation: Merck & Co., Inc., Whitehouse Station, NJ, USA.
authors.forename: Nicole
authors.initials: N
authors.lastname: Caldwell
authors.affiliation: MSD China, Shanghai, China.
authors.forename: Jue
authors.initials: J
authors.lastname: Wang
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000900:Anti-Bacterial Agents / Q000008:administration & dosage*; D019072:Antibiotic Prophylaxis / Q000379:methods*; D002443:Ceftriaxone / Q000008:administration & dosage; D002681:China; D003107:Colorectal Surgery / Q000009:adverse effects* / Q000379:methods; D004311:Double-Blind Method; D000077727:Ertapenem; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous; D007813:Laparotomy / Q000009:adverse effects / Q000379:methods; D008297:Male; D008795:Metronidazole / Q000008:administration & dosage; D008875:Middle Aged; D010919:Placebos / Q000008:administration & dosage; D013530:Surgical Wound Infection / Q000517:prevention & control*; D016896:Treatment Outcome; D055815:Young Adult; D047090:beta-Lactams / Q000008:administration & dosage*
chemical_list: D000900:Anti-Bacterial Agents; D010919:Placebos; D047090:beta-Lactams; D008795:Metronidazole; D002443:Ceftriaxone; D000077727:Ertapenem
keywords: ceftriaxone; metronidazole; β-lactams