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Randomized Controlled Trial Multicenter Study Clinical Trial
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.
- Donald R Graham, Christopher Lucasti, Osvaldo Malafaia, Ronald L Nichols, Paul Holtom, Nora Quintero Perez, Andrea McAdams, Gail L Woods, T Paulette Ceesay, and Richard Gesser.
- Springfield Clinic, Springfield, IL, 62703, USA. infectn@springfieldclinic.com
- Clin. Infect. Dis. 2002 Jun 1; 34 (11): 1460-8.
AbstractWe 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.
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