Original Investigation July 27, 2021<\/p>\n\n\n\n
Importance<\/strong> Determination of optimal treatment durations for common infectious diseases is an important strategy to preserve antibiotic effectiveness.<\/p>\n\n\n\n Objective<\/strong> To determine whether 7 days of treatment is noninferior to 14 days when using ciprofloxacin or trimethoprim\/sulfamethoxazole to treat urinary tract infection (UTI) in afebrile men.<\/p>\n\n\n\n Design, Setting, and Participants<\/strong> Randomized, double-blind, placebo-controlled noninferiority trial of afebrile men with presumed symptomatic UTI treated with ciprofloxacin or trimethoprim\/sulfamethoxazole at 2 US Veterans Affairs medical centers (enrollment, April 2014 through December 2019; final follow-up, January 28, 2020). Of 1058 eligible men, 272 were randomized.<\/p>\n\n\n\n Interventions<\/strong> Participants continued the antibiotic prescribed by their treating clinician for 7 days of treatment and were randomized to receive continued antibiotic therapy (n\u2009=\u2009136) or placebo (n\u2009=\u2009136) for days 8 to 14 of treatment.<\/p>\n\n\n\n Main Outcomes and Measures<\/strong> The prespecified primary outcome was resolution of UTI symptoms by 14 days after completion of active antibiotic treatment. A noninferiority margin of 10% was selected. The as-treated population (participants who took \u226526 of 28 doses and missed no more than 2 consecutive doses) was used for the primary analysis, and a secondary analysis included all patients as randomized, regardless of treatment adherence. Secondary outcomes included recurrence of UTI symptoms and\/or adverse events within 28 days of stopping study medication.<\/p>\n\n\n\n Results<\/strong> Among 272 patients (median [interquartile range] age, 69 [62-73] years) who were randomized, 100% completed the trial and 254 (93.4%) were included in the primary as-treated analysis. Symptom resolution occurred in 122\/131 (93.1%) participants in the 7-day group vs 111\/123 (90.2%) in the 14-day group (difference, 2.9% [1-sided 97.5% CI, \u20135.2% to \u221e]), meeting the noninferiority criterion. In the secondary as-randomized analysis, symptom resolution occurred in 125\/136 (91.9%) participants in the 7-day group vs 123\/136 (90.4%) in the 14-day group (difference, 1.5% [1-sided 97.5% CI, \u20135.8% to \u221e]) Recurrence of UTI symptoms occurred in 13\/131 (9.9%) participants in the 7-day group vs 15\/123 (12.9%) in the 14-day group (difference, \u20133.0% [95% CI, \u201310.8% to 6.2%]; P<\/em>\u2009=\u2009.70). Adverse events occurred in 28\/136 (20.6%) participants in the 7-day group vs 33\/136 (24.3%) in the 14-day group.<\/p>\n\n\n\n Conclusions and Relevance<\/strong> Among afebrile men with suspected UTI, treatment with ciprofloxacin or trimethoprim\/sulfamethoxazole for 7 days was noninferior to 14 days of treatment with regard to resolution of UTI symptoms by 14 days after antibiotic therapy. The findings support the use of a 7-day course of ciprofloxacin or trimethoprim\/sulfamethoxazole as an alternative to a 14-day course for treatment of afebrile men with UTI.<\/p>\n\n\n\n