Short-course cipro for pyelonephritis: unapproved regimen shows promise

OB/GYN News, Nov 1, 2003 by Bruce Jancin

CHICAGO -- Seven days of oral ciprofloxacin is a highly effective and well-tolerated treatment for community-acquired acute uncomplicated pyelonephritis, Dr. David Elkharrat reported at the annual Interscience Conference on Antimicrobial Agents and Chemotherapy.

The advantages of this unapproved regimen are its simplicity and brevity, compared with conventional therapies that typically call for at least 14 days of antimicrobial treatment, often with more than one agent, said Dr. Elkharrat, chief of the emergency department at Lariboisiere University Hospital in Paris.

He reported on a prospective, uncontrolled study in which 171 women who presented to 35 French emergency departments with a presumptive diagnosis of acute uncomplicated pyelonephritis were treated with 500 nag oral ciprofloxacin twice daily for 1 week.

The presumptive diagnosis was based on the presence of fever, flank pain or costovertebral tenderness upon palpation, and a positive urine dipstick test.

The diagnosis was subsequently confirmed in 122 patients in whom abdominal ultrasound was normal and a urophatogen was identified in urine and/or blood cultures; these women constituted the study population.

The primary end point was bacterial eradication at follow-up 5-9 days post treatment, and this was achieved in 93.4% of patients. The overall clinical cure rate at this time point was 93.5%, with a clinical cure rate of 95.5% in the 22 patients with positive baseline blood cultures. The causative uropathogen was identified as Escherichia coli in 121 patients and Staphylococcus saprophyticus in 1 patient.

At extended follow-up 22-48 days post treatment, continued bacterial eradication was documented in 78.1% of the women who had bacterial eradication at earlier follow-up.

Continued eradication was also seen in 15 of the 21 initially bacteremic patients with eradication at first follow-up.

The continued clinical cure rate at extended follow-up was 83.1%, Dr. Elkharrat said at the meeting, sponsored by the American Society for Microbiology.

Drug-related adverse events were reported in 12.9% of patients--mainly gastrointestinal complaints, especially nausea, and sleep disturbances. None led to treatment discontinuation.

Although this was an uncontrolled study, the outcomes compare favorably to those of approved therapies and were quite similar to those in an earlier double-blind randomized trial comparing 7 days of ciprofloxacin to 14 days of trimethoprim-sulfamethoxazole, he said.