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Kalpana Gupta, MD, MPH; Thomas M. Hooton, MD; Pacita L. Roberts, MS; Walter E. Stamm, MD

Arch Intern Med. 2007;167(20):2207-2212.

Background  There is a paucity of data on the efficacy of nitrofurantoin for the treatment of acute uncomplicated cystitis in regimens shorter than 7 days. Evidence-based use of this drug is increasingly important as trimethoprim-sulfamethoxazole resistance among uropathogens increases.

Methods  To assess the efficacy of nitrofurantoin vs trimethoprim-sulfamethoxazole, 338 women aged 18 to 45 years with acute uncomplicated cystitis were randomized to open-label treatment with either trimethoprim-sulfamethoxazole, 1 double-strength tablet twice daily for 3 days, or nitrofurantoin, 100 mg twice daily for 5 days. Clinical cure 30 days after therapy was the main outcome measure. Secondary outcomes included clinical and microbiological cure rates 5 to 9 days after therapy and, for trimethoprim-sulfamethoxazole–treated women, clinical cure stratified by the trimethoprim-sulfamethoxazole susceptibility of the uropathogen.

Results  Clinical cure was achieved in 79% of the trimethoprim-sulfamethoxazole group and in 84% of the nitrofurantoin group, for a difference of –5% (95% confidence interval, –13% to 4%). Clinical and microbiological cure rates at the first follow-up visit were also equivalent between the 2 groups. In the trimethoprim-sulfamethoxazole arm, 7 of 17 women (41%) with a trimethoprim-sulfamethoxazole–nonsusceptible isolate had a clinical cure compared with 84% of women with a trimethoprim-sulfamethoxazole–susceptible isolate (P < .001).

Conclusion  A 5-day course of nitrofurantoin is equivalent clinically and microbiologically to a 3-day course of trimethoprim-sulfamethoxazole and should be considered an effective fluoroquinolone-sparing alternative for the treatment of acute cystitis in women.

Trial Registration  clinicaltrials.gov Identifier: NCT00391651

Author Affiliations: Departments of Medicine and Schools of Medicine, Yale University, New Haven, Connecticut (Dr Gupta); University of Miami, Miami, Florida (Dr Hooton); and University of Washington, Seattle (Ms Roberts and Dr Stamm).

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