Seven days of antibiotic therapy for afebrile men with suspected urinary tract infections (UTI) was as effective as a 14-day regimen, according to results from a randomized, double-blind trial. In over 250 men with presumed symptomatic UTI included in the as-treated analysis, resolution of symptoms by 14 days after completion of antibiotic treatment occurred in 93.1% of the 7-day group compared with 90.2% of the 14-day group -- a difference of 2.9%, which met the noninferiority criterion of 10%, reported Dimitri Drekonja, MD, of Minneapolis Veterans Affairs Health Care System, and colleagues in JAMA. In the secondary as-randomized analysis of over 270 men, symptom resolution occurred in 91.9% of participants in the 7-day group compared with 90.4% in the 14-day group -- a difference of 1.5%. "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," the authors concluded. "Shorter courses of antibiotic treatment are inherently easier for patients and are preferred when clinical outcomes are noninferior compared with longer duration of treatment," wrote Daniel Morgan, MD, and K. C. Coffey, MD, MPH, both of the University of Maryland School of Medicine and the VA Maryland Healthcare System in Baltimore, in an accompanying editorial. "This study should inform guidelines and should give clinicians confidence to treat thoughtfully for the shortest effective treatment duration." Shorter-duration antibiotic treatment has been shown to be as effective as long-duration treatment for infections including pneumonia, intra-abdominal infections, osteomyelitis, cellulitis, and UTI in women, and thus represent an important strategy for preserving the effectiveness of these drugs, noted Drekonja and colleagues. In the case of UTI in men, the evidence is mixed regarding optimal treatment duration. Therefore, in order to determine whether afebrile men with UTI can benefit from shorter-duration treatment, the authors conducted a placebo-controlled noninferiority trial of antibiotic therapy for 7 versus 14 days from April 2014 through December 2019. The trial included 272 patients from two U.S. VA medical centers who used the antibiotic prescribed by their treating clinician for 7 days and were then randomized 1:1 to receive continued antibiotic therapy or placebo for days 8 to 14. The team limited its investigation to ciprofloxacin and trimethoprim/sulfamethoxazole since these drugs accounted for 90% of treatment courses for patients in the VA at the time. Patients were a median age of 69, and 77.9% were white, 18.0% were Black, and 2.2% were Native American. Demographic factors, baseline comorbidities, and Charlson Comorbidity Index scores were similar among the group. Of the patients enrolled, 254 were considered to be the as-treated population (participants who took at least 26 of 28 doses and missed no more than two consecutive doses) and were used for the primary analysis. The primary outcome -- resolution of UTI symptoms by day 14 after completion of antibiotic treatment -- occurred in 233 of 254 patients in the as-treated population (91.7%) and in 248 of 272 (91.2%) patients in the as-randomized population. Reported recurrence of UTI symptoms was similar between the two groups in both the as-treated population (9.9% in the 7-day group vs 12.9% in the 14-day group; P=0.70) and the as-randomized population (10.3% and 16.9%, respectively; P=0.20). Of the patients in the as-treated population who reported adverse events -- mostly diarrhea, nausea, and abnormal blood glucose readings -- 19.8% were in the 7-day group and 23.6% were in the 14-day group. For the as-randomized group, these proportions were 20.6% and 24.3%, respectively. Morgan and Coffey noted that since the time the study was initiated, the FDA began requiring a black box warning on ciprofloxacin, indicating that the potential for serious adverse events outweighs its benefits in treating uncomplicated UTIs, which was a limitation to the study. Additionally, they said that the clinical definition of UTI used in the study allowed for the enrollment of approximately one-third of patients without microbiologic evidence of UTI, "which could bias results toward the null." "Antibiotics are frequently prescribed for patients with dysuria, frequency, hematuria, and even symptoms not localized to the urinary tract such as altered mental status and general malaise," the editorialists wrote. "Practice should evolve to better identify noninfectious symptoms and spare patients antibiotic exposure and adverse effects, although little progress has been made to date, as evidenced by overtreatment of asymptomatic bacteriuria." Source
