Nitrofurantoin has higher cure rates than fosfomycin for uncomplicated cystitis, study finds
Nitrofurantoin can be the agent of choice in regions of the world where susceptibility is preserved, editorialists said.
A five-day course of nitrofurantoin offered significantly greater clinical and microbiologic resolution of uncomplicated urinary tract infections (UTIs) in women at 28 days compared to single-dose fosfomycin, a study found.
To compare the clinical and microbiologic efficacy of the two regimens in women with uncomplicated cystitis, researchers conducted a multinational, open-label, analyst-blinded, randomized clinical trial of 513 nonpregnant women ages 18 years and older with symptoms of lower UTI (dysuria, urgency, frequency, or suprapubic tenderness), a positive urine dipstick result (with detection of nitrites or leukocyte esterase), and no known colonization or previous infection with uropathogens resistant to the antibiotics.
Participants were randomized in a 1:1 ratio to oral nitrofurantoin, 100 mg three times daily for five days (n=255), or a single 3-g dose of oral fosfomycin (n=258). The primary outcome was clinical response, defined as clinical resolution (complete resolution of symptoms and signs of UTI without prior failure), failure (need for additional or change in antibiotic treatment due to UTI or discontinuation due to lack of efficacy), or indeterminate (persistence of symptoms without objective evidence of infection).
Secondary outcomes included bacteriologic response and incidence of adverse events. Results were published online April 22 by JAMA.
Clinical resolution through day 28 was achieved in 171 of 244 patients (70%) receiving nitrofurantoin compared to 139 of 241 patients (58%) receiving fosfomycin (difference, 12%; 95% CI, 4% to 21%; P=0.004). Microbiologic resolution occurred in 129 of 175 patients in the nitrofurantoin group (74%) compared to 103 of 163 in the fosfomycin group (63%) (difference, 11%; 95% CI, 1% to 20%; P=0.04). Adverse events were few and primarily gastrointestinal.
An editorial concluded that the study improved on previous ones by using an intention-to-treat analysis, evaluating missing data through multiple imputation and sensitivity analyses, and including microbiologic outcomes. “In regions of the world where nitrofurantoin susceptibility is preserved, particularly for E. coli, nitrofurantoin can be the agent of choice,” the editorialists wrote.