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Oral ciprofloxacin for 7-10 days is a first-line treatment for uncomplicated acute pyelonephritis in nonpregnant women recommended by the Infectious Diseases Society of America and European Society for Microbiology and Infectious Diseases. This recommendation is based in part on a randomized trial that compared ciprofloxacin for 7 days vs. co-trimoxazole for 14 days (JAMA 2000 Mar 22-29;283(12):1583). That trial enrolled young women (median age 25 years) with mild to moderate illness, and the study population was found to have a high prevalence of co-trimoxazole resistance. Treatment duration > 7 days remains common, but longer treatment is associated with increased risk of developing resistance. A new randomized noninferiority trial evaluated the generalizability of 7-day treatment with ciprofloxacin in an older and sicker population.
A total of 248 women (median age 43 years) with a preliminary diagnosis of acute pyelonephritis were randomized to receive ciprofloxacin 500 mg orally twice daily for 7 days vs. 14 days. The first week of treatment was open-label, and the second week was placebo-controlled. 69 women were excluded from the study for incorrect diagnosis, drug resistance, or other ineligibility, and an additional 23 women were excluded from analysis for loss to follow-up or other protocol violations. Bacteremia was present in 27%.
The primary outcome was clinical cure, defined as complete resolution of symptoms during treatment with no recurrence of symptoms or signs of urinary tract infection during follow-up. The clinical cure rates at 10-14 days were 97% with 7-day treatment and 96% with 14-day treatment (noninferiority established) (level 2 [mid-level] evidence). At 42-63 days, both groups had a clinical cure rate of 93% (noninferiority established). There was no significant difference in overall rates of adverse events, but 7-day treatment was associated with lower incidence of mucosal candida infection after the first week (0% vs. 5%, p = 0.036) (Lancet 2012 Aug 4;380(9840):484).
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