Journal of Antimicrobial Chemotherapy (2004) 53, ii67-ii74
© 2004 The British Society for Antimicrobial Chemotherapy
Supplement |
Treatment of complicated urinary tract infection in adults: combined analysis of two randomized, double-blind, multicentre trials comparing ertapenem and ceftriaxone followed by appropriate oral therapy
1 Alabama Research Center, Birmingham, AL, USA; 2 Merck Research Laboratories, West Point, PA, USA
Abstract
The efficacy and safety of parenteral ertapenem, a Group 1 carbapenem, 1 g once a day, for the treatment of complicated urinary tract infections (UTIs; i.e. acute pyelonephritis, UTI in men, or UTI associated with obstruction, foreign body or a urological abnormality interfering with normal voiding) in adults, were compared with those of parenteral ceftriaxone, 1 g once a day, in two similarly designed prospective, double-blind, randomized studies. In both studies, patients could be switched to an oral agent after 
3 days of parenteral study therapy. At entry, 850 patients were stratified according to whether they had acute pyelonephritis or other complicated UTI without acute pyelonephritis. Two hundred and fifty-six patients in the ertapenem group and 224 in the ceftriaxone group were microbiologically evaluable. Ninety-six per cent of these patients were switched to oral therapy, usually ciprofloxacin; the median (range) duration of parenteral and total therapy, respectively, was 4 (2–14) days and 13 (14–18) days for ertapenem and 4 (2–14) days and 13 (3–17) days for ceftriaxone. The most common pathogens were Escherichia coli and Klebsiella pneumoniae, which accounted for 64.7% and 9.8% of isolates, respectively. At the primary efficacy endpoint 5–9 days after treatment, 229 (89.5%) patients who received ertapenem and 204 (91.1%) patients who received ceftriaxone had a favourable microbiological response (95% confidence interval, –7.4 to 4.0), indicating that outcomes in the two treatment groups were equivalent. Success rates in both treatment groups were similar when compared by stratum and severity of infection. The frequency and severity of drug-related adverse events were generally similar in both treatment groups. In this combined analysis, ertapenem was highly effective therapy for the treatment of complicated UTIs in adults with moderate-to-severe disease.
Keywords: acute pyelonephritis, carbapenems, antimicrobial agents, efficacy, safety
Footnotes
* Present address. Department of Pathology, University of Utah, ARUP Laboratories, 500 Chipeta Way, Salt Lake City, UT 84108, USA.
Present address: Novartis Pharmaceutical Corp., E. Hannover, NJ, USA.
¶ Corresponding author. Merck & Co. Inc., BL3–4, PO Box 4, West Point, PA 19486-0004, USA. Tel: +1-484-344-3176; Fax: +1-484-344-3404; E-mail: richard_gesser{at}merck.com
Members of the study groups are listed in the Acknowledgements.