Ertapenem once daily versus piperacillin-tazobactam 4 times per day for treatment of complicated skin and skin-structure infections in adults: results of a prospective, randomized, double-blind multicenter study.
We conducted a prospective, randomized, double-blind trial comparing ertapenem (1 g once daily) with piperacillin-tazobactam (3.375 g every 6 h) as parenteral treatment for 540 adults with complicated skin and skin-structure infections. The most common diagnoses were skin or soft-tissue abscesses and lower-extremity infections associated with diabetes. The mean duration (+/- standard deviation) of therapy was 9.1+/-3.1 days for ertapenem and 9.8+/-3.3 days for piperacillin-tazobactam. At the assessment of primary efficacy end point, 10-21 days after treatment, 82.4% of those who received ertapenem and 84.4% of those who received piperacillin-tazobactam were cured. The difference in response rates, adjusting for the patients' assigned strata, was -2.0% (95% confidence interval, -10.2% to 6.2%), indicating that the response rates in the 2 treatment groups were equivalent. Cure rates for the 2 treatment groups were similar when compared by stratum, diagnosis, and severity of infection. The frequency and severity of drug-related adverse events were similar in the treatment groups.
Graham
Donald R
DR
Springfield Clinic, Springfield, IL, 62703, USA. infectn@springfieldclinic.com
Lucasti
Christopher
C
Malafaia
Osvaldo
O
Nichols
Ronald L
RL
Holtom
Paul
P
Perez
Nora Quintero
NQ
McAdams
Andrea
A
Woods
Gail L
GL
Ceesay
T Paulette
TP
Gesser
Richard
R
D000328:Adult; D000900:Anti-Bacterial Agents / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination / Q000009:adverse effects / Q000627:therapeutic use*; D004791:Enzyme Inhibitors / Q000009:adverse effects / Q000627:therapeutic use; D000077727:Ertapenem; D005260:Female; D006801:Humans; D007769:Lactams; D008297:Male; D008826:Microbial Sensitivity Tests; D008875:Middle Aged; D010397:Penicillanic Acid / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use*; D010406:Penicillins / Q000627:therapeutic use*; D010878:Piperacillin / Q000009:adverse effects / Q000627:therapeutic use*; D011446:Prospective Studies; D011550:Pseudomonas aeruginosa / Q000187:drug effects; D012871:Skin Diseases / Q000188:drug therapy*; D013211:Staphylococcus aureus / Q000187:drug effects; D000078142:Tazobactam; D016896:Treatment Outcome; D047090:beta-Lactams
D000900:Anti-Bacterial Agents; D004791:Enzyme Inhibitors; D007769:Lactams; D010406:Penicillins; D047090:beta-Lactams; D010397:Penicillanic Acid; D000077727:Ertapenem; D000078142:Tazobactam; D010878:Piperacillin