Comparison of ciprofloxacin (7 days) and trimethoprim-sulfamethoxazole (14 days) for acute uncomplicated pyelonephritis pyelonephritis in women: a randomized trial.
BACKGROUND
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.


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


METHODS
Twenty-five outpatient centers in the United States.


METHODS
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.


METHODS
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).


METHODS
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.
Talan
D A
DA
Department of Medicine, Olive View-UCLA Medical Center, University of California, Los Angeles 91342, USA. idnet@ucla.edu
Stamm
W E
WE
Hooton
T M
TM
Moran
G J
GJ
Burke
T
T
Iravani
A
A
Reuning-Scherer
J
J
Church
D A
DA
D000208:Acute Disease; D000328:Adult; D000890:Anti-Infective Agents / Q000008:administration & dosage / Q000191:economics / Q000627:therapeutic use*; D000892:Anti-Infective Agents, Urinary / Q000008:administration & dosage / Q000191:economics / Q000627:therapeutic use*; D002939:Ciprofloxacin / Q000008:administration & dosage / Q000191:economics / Q000627:therapeutic use*; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004352:Drug Resistance, Microbial; D005260:Female; D017048:Health Care Costs; D006801:Humans; D008875:Middle Aged; D011704:Pyelonephritis / Q000188:drug therapy* / Q000191:economics / Q000382:microbiology; D015662:Trimethoprim, Sulfamethoxazole Drug Combination / Q000008:administration & dosage / Q000191:economics / Q000627:therapeutic use*
D000890:Anti-Infective Agents; D000892:Anti-Infective Agents, Urinary; D002939:Ciprofloxacin; D015662:Trimethoprim, Sulfamethoxazole Drug Combination