PMID- 25151205
OWN - NLM
STAT- MEDLINE
DCOM- 20150701
LR  - 20181202
IS  - 1460-2091 (Electronic)
IS  - 0305-7453 (Linking)
VI  - 69
IP  - 12
DP  - 2014 Dec
TI  - Ertapenem prophylaxis of surgical site infections in elective colorectal surgery 
      in China: a multicentre, randomized, double-blind, active-controlled study.
PG  - 3379-86
LID - 10.1093/jac/dku302 [doi]
AB  - OBJECTIVES: 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.
CI  - (c) The Author 2014. Published by Oxford University Press on behalf of the British 
      Society for Antimicrobial Chemotherapy. All rights reserved. For Permissions, 
      please e-mail: journals.permissions@oup.com.
FAU - Leng, Xi-sheng
AU  - Leng XS
AD  - Department of Surgery, Peking University People's Hospital, Beijing, China 
      lengxs2003@yahoo.com.cn.
FAU - Zhao, Yong-jie
AU  - Zhao YJ
AD  - Department of Surgery, Tianjin People's Hospital, Tianjin, China.
FAU - Qiu, Hui-zhong
AU  - Qiu HZ
AD  - Department of General Surgery, Peking Union Medical College Hospital, Beijing, 
      China.
FAU - Cao, Yong-kuan
AU  - Cao YK
AD  - Department of General Surgery, Chengdu Military General Hospital, Chengdu, China.
FAU - Zhu, Wei-hua
AU  - Zhu WH
AD  - Department of Surgery, Peking University People's Hospital, Beijing, China.
FAU - Shen, Ju-fang
AU  - Shen JF
AD  - MSD China, Shanghai, China.
FAU - Paschke, Amanda
AU  - Paschke A
AD  - Merck & Co., Inc., Whitehouse Station, NJ, USA.
FAU - Dai, Wei-min
AU  - Dai WM
AD  - PAREXEL International, Shanghai, China.
FAU - Caldwell, Nicole
AU  - Caldwell N
AD  - Merck & Co., Inc., Whitehouse Station, NJ, USA.
FAU - Wang, Jue
AU  - Wang J
AD  - MSD China, Shanghai, China.
LA  - eng
SI  - ClinicalTrials.gov/NCT01254344
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20140823
PL  - England
TA  - J Antimicrob Chemother
JT  - The Journal of antimicrobial chemotherapy
JID - 7513617
RN  - 0 (Anti-Bacterial Agents)
RN  - 0 (Placebos)
RN  - 0 (beta-Lactams)
RN  - 140QMO216E (Metronidazole)
RN  - 75J73V1629 (Ceftriaxone)
RN  - G32F6EID2H (Ertapenem)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Anti-Bacterial Agents/*administration & dosage
MH  - Antibiotic Prophylaxis/*methods
MH  - Ceftriaxone/administration & dosage
MH  - China
MH  - Colorectal Surgery/*adverse effects/methods
MH  - Double-Blind Method
MH  - Ertapenem
MH  - Female
MH  - Humans
MH  - Infusions, Intravenous
MH  - Laparotomy/adverse effects/methods
MH  - Male
MH  - Metronidazole/administration & dosage
MH  - Middle Aged
MH  - Placebos/administration & dosage
MH  - Surgical Wound Infection/*prevention & control
MH  - Treatment Outcome
MH  - Young Adult
MH  - beta-Lactams/*administration & dosage
OTO - NOTNLM
OT  - ceftriaxone
OT  - metronidazole
OT  - beta-lactams
EDAT- 2014/08/26 06:00
MHDA- 2015/07/02 06:00
CRDT- 2014/08/25 06:00
PHST- 2014/08/25 06:00 [entrez]
PHST- 2014/08/26 06:00 [pubmed]
PHST- 2015/07/02 06:00 [medline]
AID - dku302 [pii]
AID - 10.1093/jac/dku302 [doi]
PST - ppublish
SO  - J Antimicrob Chemother. 2014 Dec;69(12):3379-86. doi: 10.1093/jac/dku302. Epub 
      2014 Aug 23.