Evaluation of outpatient treatment with ertapenem in a double blind controlled clinical trial of complicated skin/skin structure infections.
OBJECTIVE
The patient characteristics and the efficacy and safety of ertapenem 1 g once daily vs. piperacillin-tazobactam 13.5 g divided Q6H were examined in patients who received outpatient parenteral antimicrobial therapy (OPAT) during a clinical trial of complicated skin/skin structure infections.


METHODS
The population analyzed included 363 patients treated at US sites in a large randomized double-blind study.


RESULTS
In this analysis, 146 (40%) patients at 19 (66%) sites were managed by OPAT. A lower proportion of treated patients who received OPAT had severe infection (12% vs. 20%, P=0.03). In evaluable patients managed by OPAT, 45 (83.3%) of 54 treated with ertapenem and 41 (82.0%) of 50 treated with piperacillin-tazobactam were cured at the test of cure assessment 10-21 days post-therapy (OR 1.2 (95% CI, 0.4-3.2), P=0.78). The safety profile of both drugs was generally similar; diarrhoea was the most common adverse event in both groups.


CONCLUSIONS
In this trial of complicated skin/skin structure infection, OPAT was commonly used by US investigators. Among patients who received OPAT, ertapenem 1 g daily was as effective as piperacillin-tazobactam 3.375 g Q6H.
Gesser
Richard M
RM
Merck Research Laboratories, West Point, PA, USA. richard_gesser@merck.com
McCarroll
Kathleen A
KA
Woods
Gail L
GL
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000900:Anti-Bacterial Agents / Q000627:therapeutic use*; D016009:Chi-Square Distribution; D004311:Double-Blind Method; D004359:Drug Therapy, Combination / Q000627:therapeutic use*; D004791:Enzyme Inhibitors / Q000627:therapeutic use*; D000077727:Ertapenem; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous; D007769:Lactams / Q000627:therapeutic use*; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D010397:Penicillanic Acid / Q000031:analogs & derivatives* / Q000627:therapeutic use*; D010878:Piperacillin / Q000627:therapeutic use*; D011446:Prospective Studies; D012871:Skin Diseases / Q000188:drug therapy* / Q000382:microbiology; D018709:Statistics, Nonparametric; D000078142:Tazobactam; D016896:Treatment Outcome; D047090:beta-Lactams
D000900:Anti-Bacterial Agents; D004791:Enzyme Inhibitors; D007769:Lactams; D047090:beta-Lactams; D010397:Penicillanic Acid; D000077727:Ertapenem; D000078142:Tazobactam; D010878:Piperacillin