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Antimicrobial Agents and Chemotherapy, September 2002, p. 2895-2900, Vol. 46, No. 9
0066-4804/02/$04.00+0     DOI: 10.1128/AAC.46.9.2895-2900.2002
Copyright © 2002, American Society for Microbiology. All Rights Reserved.

Ertapenem versus Ceftriaxone Followed by Appropriate Oral Therapy for Treatment of Complicated Urinary Tract Infections in Adults: Results of a Prospective, Randomized, Double-Blind Multicenter Study

Kevin M. Tomera,1 Emmanuel A. Burdmann,2 Oscar G. Pamo Reyna,3 Qi Jiang,4 Wendy M. Wimmer,4 Gail L. Woods,4 Richard M. Gesser,4* and the Protocol 014 Study Group{dagger}

Alaska Clinical Research Center, Anchorage, Alaska,1 Sao Jose do Rio Preto Medical School, Sao Paulo, Brazil,2 Peruvian University Cayetano Heredia of Lima, Lima, Peru,3 Merck Research Laboratories, West Point, Pennsylvania4

Received 17 April 2002/ Returned for modification 3 June 2002/ Accepted 19 June 2002

The efficacy and safety of intravenous (i.v.) ertapenem (1 g once a day) with the option to switch to an oral agent for treatment of adults with complicated urinary tract infections (UTIs) were compared with that of i.v. ceftriaxone (1 g daily) with the same oral switch option in a multicenter, double-blind, prospective, randomized study. At entry, 592 patients were assigned to one of two strata: acute pyelonephritis or other complicated UTI without acute pyelonephritis. After a minimum of 3 days, patients could be switched to an oral antimicrobial agent. A total of 159 patients in the ertapenem group and 171 patients in the ceftriaxone group were microbiologically evaluable. Approximately 95% of patients in each treatment group were switched to oral therapy. The most common pathogens were Escherichia coli and Klebsiella pneumoniae. At the primary efficacy endpoint 5 to 9 days after treatment, 91.8% of patients who received ertapenem and 93.0% of those who received ceftriaxone had a favorable microbiological response (95% confidence interval for the difference, adjusting for strata, -7.6 to 5.1%), indicating that outcomes in the two treatment groups were equivalent. Microbiological success rates for the two treatment groups were similar when compared by stratum and also by severity of infection. The frequency and severity of drug-related adverse events were generally similar in both treatment groups. In this study, ertapenem was as effective as ceftriaxone for the initial treatment of complicated UTIs in adults, was generally well tolerated, and had a similar overall safety profile.

* Corresponding author. Mailing address: Merck & Co., Inc., BL3-4, P.O. Box 4, West Point, PA 19486-0004. Phone: (484) 344-3176. Fax: (484) 344-3404. E-mail: richard_gesser{at}merck.com.

{dagger} Members of the Protocol 014 Study Group included Elizabeth A. Albertson, Winston-Salem, N.C.; Mohamed S. Al-Ibrahim, Baltimore, Md.; Emmanuel A. Burdmann, Sao Paulo, Brazil; Thomas F. Burke, Olympia, Wash.; Stacy Childs, Cheyenne, Wyo.; Clair Cox, Memphis, Tenn.; Robert H. K. Eng, East Orange, N.J.; Elliot Frank, Neptune, N.J.; Robert Brooks Gainer II, Morgantown, W.Va.; Fernando Gonzalez Fuenzalida, Santiago, Chile; John A. Gezon, Salt Lake City, Utah; Theodore Herman, Buffalo, N.Y.; Karny Jacoby, Seattle, Wash.; Andrew H. Krinsky, Sarasota, Fla.; Richard E. Landau, Sellersville, Pa.; William Moseley, San Diego, Calif.; M. Sigfrido Rangel-Frausto, Mexico City, Mexico; Gilberto Recinos-Mijangos, Guatemala City, Guatemala; John F. Reinhardt, Newark, Del.; Oscar G. Pamo Reyna, Lima, Peru; Stuart Sarshik, Sellersville, Pa.; Albrecht Schilling, Munich, Germany; Kevin M. Tomera, Anchorage, Alaska; John Tuttle, Jr., Lexington, Ky.; Yair Walzer, Memphis, Tenn.; and Glen Wells, Birmingham, Ala.

Antimicrobial Agents and Chemotherapy, September 2002, p. 2895-2900, Vol. 46, No. 9
0066-4804/02/$04.00+0     DOI: 10.1128/AAC.46.9.2895-2900.2002
Copyright © 2002, American Society for Microbiology. All Rights Reserved.



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