Ertapenem versus cefotetan prophylaxis in elective colorectal surgery.
BACKGROUND
Ertapenem, a long-acting carbapenem, may be an alternative to the recommended prophylactic antibiotic cefotetan.


METHODS
In this randomized, double-blind trial, we assessed the efficacy and safety of antibiotic prophylaxis with ertapenem, as compared with cefotetan, in patients undergoing elective colorectal surgery. A successful outcome was defined as the absence of surgical-site infection, anastomotic leakage, or antibiotic use 4 weeks postoperatively. All adverse events were collected until 14 days after the administration of antibiotic prophylaxis.


RESULTS
Of the 1002 patients randomly assigned to study groups, 901 (451 in the ertapenem group and 450 in the cefotetan group) qualified for the modified intention-to-treat analysis, and 672 (338 in the ertapenem group and 334 in the cefotetan group) were included in the per-protocol analysis. After adjustment for strata, in the modified intention-to-treat analysis, the rate of overall prophylactic failure was 40.2% in the ertapenem group and 50.9% in the cefotetan group (absolute difference, -10.7%; 95% confidence interval [CI], -17.1 to -4.2); in the per-protocol analysis, the failure rate was 28.0% in the ertapenem group and 42.8% in the cefotetan group (absolute difference, -14.8%; 95% CI, -21.9 to -7.5). Both analyses fulfilled statistical criteria for the superiority of ertapenem. In the modified intention-to-treat analysis, the most common reason for failure of prophylaxis in both groups was surgical-site infection: 17.1% in the ertapenem group and 26.2% in the cefotetan group (absolute difference, -9.1; 95% CI, -14.4 to -3.7). In the treated population, the overall incidence of Clostridium difficile infection was 1.7% in the ertapenem group and 0.6% in the cefotetan group (P=0.22).


CONCLUSIONS
Ertapenem is more effective than cefotetan in the prevention of surgical-site infection in patients undergoing elective colorectal surgery but may be associated with an increase in C. difficile infection. (ClinicalTrials.gov number, NCT00090272 [ClinicalTrials.gov].).
Itani
Kamal M F
KM
Veterans Affairs Boston Healthcare System and Boston University Medical School, Boston, MA 02132, USA. kitani@med.va.gov
Wilson
Samuel E
SE
Awad
Samir S
SS
Jensen
Erin H
EH
Finn
Tyler S
TS
Abramson
Murray A
MA
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000704:Analysis of Variance; D000900:Anti-Bacterial Agents / Q000009:adverse effects / Q000627:therapeutic use*; D019072:Antibiotic Prophylaxis; D015313:Cefotetan / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D016360:Clostridioides difficile; D003015:Clostridium Infections; D003107:Colorectal Surgery; D004311:Double-Blind Method; D017558:Elective Surgical Procedures; D000077727:Ertapenem; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012307:Risk Factors; D013530:Surgical Wound Infection / Q000517:prevention & control*; D017211:Treatment Failure; D047090:beta-Lactams / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*
D000900:Anti-Bacterial Agents; D047090:beta-Lactams; D015313:Cefotetan; D000077727:Ertapenem