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-sulfamethoxazoletreated
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-sulfamethoxazoletreated
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-sulfamethoxazoleresistant
strains.
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