Ertapenem, a long-acting carbapenem, may be an alternative to the recommended prophylactic antibiotic cefotetan.
In this randomized, double-blind trial, Dr Kamal Itani and colleagues assessed the efficacy and safety of antibiotic prophylaxis with ertapenem.
The research team compared the results with cefotetan, in patients undergoing elective colorectal surgery.
The team defined a successful outcome as 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.
Of the 1002 patients randomly assigned to study groups, 901 qualified for the modified intention-to-treat analysis.
|Surgical-site infection was 17% with ertapenem vs 26% cefotetan|
|New Englnd Journal of Medicine|
This included 451 in the ertapenem group and 450 in the cefotetan group.
A further 672 patients, of which 338 were in the ertapenem group and 334 in the cefotetan group, were included in the per-protocol analysis.
After the researchers adjusted for strata in the modified intention-to-treat analysis, the rate of overall prophylactic failure was 40% in the ertapenem group and 51% in the cefotetan group.
The team noted that in the per-protocol analysis, the failure rate was 28% in the ertapenem group, and 43% in the cefotetan group.
The team reported that 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.
The researchers observed that the surgical-site infection was 17% in the ertapenem group and 26% in the cefotetan group.
In the treated population, the team found that the overall incidence of Clostridium difficile infection was 2% in the ertapenem group and less than 1% in the cefotetan group.
Dr Itani's team concludes, “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.”