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

被引:98
作者
Graham, DR
Lucasti, C
Malafaia, O
Nichols, RL
Holtom, P
Perez, NQ
McAdams, A
Woods, GL
Ceesay, TP
Gesser, R
机构
[1] Springfield Clin, Springfield, IL 62703 USA
[2] S Jersey Infect Dis, Somers Point, NJ USA
[3] Tulane Univ, Sch Med, New Orleans, LA 70112 USA
[4] Univ So Calif, Med Ctr, Los Angeles, CA 90033 USA
[5] Hosp Evangelico, Curitiba, Parana, Brazil
[6] Hosp Civil Guadalajara, Mexico City, DF, Mexico
[7] Merck Res Labs, W Point, PA USA
关键词
D O I
10.1086/340348
中图分类号
R392 [医学免疫学]; Q939.91 [免疫学];
学科分类号
100102 ;
摘要
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 days 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.
引用
收藏
页码:1460 / 1468
页数:9
相关论文
共 19 条
[1]   GENERAL-GUIDELINES FOR THE CLINICAL-EVALUATION OF ANTIINFECTIVE DRUG PRODUCTS [J].
BEAM, TR ;
GILBERT, DN ;
KUNIN, CM .
CLINICAL INFECTIOUS DISEASES, 1992, 15 :S5-S32
[2]  
Breslow NE, 1980, IARC SCI PUBLICATION, V32
[3]  
Cochran W.G., 1953, A Wiley publication in applied statistics
[4]   SOME METHODS FOR STRENGTHENING THE COMMON X2 TESTS [J].
COCHRAN, WG .
BIOMETRICS, 1954, 10 (04) :417-451
[5]  
FILE TM, 1994, EUR J SURG S, V573, P51
[6]  
FORAN RM, 1991, DICP ANN PHARMAC, V25, P546
[7]   In vitro activities of ertapenem (MK-0826) against clinical bacterial isolates from 11 North American medical centers [J].
Fuchs, PC ;
Barry, AL ;
Brown, SD .
ANTIMICROBIAL AGENTS AND CHEMOTHERAPY, 2001, 45 (06) :1915-1918
[8]   FOOT INFECTIONS IN DIABETIC-PATIENTS - THE ROLE OF ANAEROBES [J].
GERDING, DN .
CLINICAL INFECTIOUS DISEASES, 1995, 20 :S283-S288
[9]   Comparative in vitro activities of ertapenem (MK-0826) against 1,001 anaerobes isolated from human intra-abdominal infections [J].
Goldstein, EJC ;
Citron, DM ;
Merriam, CV ;
Warren, Y ;
Tyrrell, KL .
ANTIMICROBIAL AGENTS AND CHEMOTHERAPY, 2000, 44 (09) :2389-2394
[10]  
*NAT COMM CLIN LAB, 1997, M2A6 NCCLS