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A Randomized Trial

David A. Talan, MD; Walter E. Stamm, MD; Thomas M. Hooton, MD; Gregory J. Moran, MD; Thomas Burke, MD; Abdollah Iravani, MD; Jonathan Reuning-Scherer, PhD; Deborah A. Church, MD

JAMA. 2000;283:1583-1590.

Context  The optimal antimicrobial regimen and treatment duration for acute uncomplicated pyelonephritis are unknown.

Objective  To compare the efficacy and safety of a 7-day ciprofloxacin regimen and a 14-day trimethoprim-sulfamethoxazole regimen for the treatment of acute pyelonephritis in women.

Design  Randomized, double-blind comparative trial conducted from October 1994 through January 1997.

Setting  Twenty-five outpatient centers in the United States.

Patients  Of 378 enrolled premenopausal women aged at least 18 years with clinical diagnosis of acute uncomplicated pyelonephritis, 255 were included in the analysis. Other individuals were excluded for no baseline causative organism, inadequate receipt of study drug, loss to follow-up, no appropriate cultures, and other reasons.

Interventions  Patients were randomized to oral ciprofloxacin, 500 mg twice per day for 7 days (with or without an initial 400-mg intravenous dose) followed by placebo for 7 days (n = 128 included in analysis) vs trimethoprim-sulfamethoxazole, 160/800 mg twice per day for 14 days (with or without intravenous ceftriaxone, 1 g) (n = 127 included in the analysis).

Main Outcome Measure  Continued bacteriologic and clinical cure, such that alternative antimicrobial drugs were not required, among evaluable patients through the 4- to 11-day posttherapy visit, compared by treatment group.

Results  At 4 to 11 days posttherapy, bacteriologic cure rates were 99% (112 of 113) for the ciprofloxacin regimen and 89% (90 of 101) for the trimethoprim-sulfamethoxazole regimen (95% confidence interval [CI] for difference, 0.04-0.16; P = .004). Clinical cure rates were 96% (109 of 113) for the ciprofloxacin regimen and 83% (92 of 111) for the trimethoprim-sulfamethoxazole regimen (95% CI, 0.06-0.22; P = .002). Escherichia coli, which caused more than 90% of infections, was more frequently resistant to trimethoprim-sulfamethoxazole (18%) than to ciprofloxacin (0%; P<.001). Among trimethoprim-sulfamethoxazole–treated patients, drug resistance was associated with greater bacteriologic and clinical failure rates (P<.001 for both). Drug-related adverse events occurred in 24% of 191 ciprofloxacin-treated patients and in 33% of 187 trimethoprim-sulfamethoxazole–treated patients, respectively (95% CI, -0.001 to 0.2).

Conclusions  In our study of outpatient treatment of acute uncomplicated pyelonephritis in women, a 7-day ciprofloxacin regimen was associated with greater bacteriologic and clinical cure rates than a 14-day trimethoprim-sulfamethoxazole regimen, especially in patients infected with trimethoprim-sulfamethoxazole–resistant strains.

Author Affiliations: Divisions of Emergency Medicine and Infectious Diseases, Department of Medicine, Olive View-UCLA Medical Center, University of California, Los Angeles (Drs Talan and Moran); Division of Infectious Diseases, Department of Medicine (Drs Stamm, Hooton, and Burke), Harborview Medical Center, University of Washington, Seattle (Drs Stamm and Hooton); Providence St Peter's Hospital, Olympia, Wash (Dr Burke); Central Florida Medical Research Center, Orlando (Dr Iravani); and Bayer Corporation Pharmaceutical Division, West Haven, Conn (Drs Reuning-Scherer and Church).

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