Disclosures: Drekonja reports no relevant financial disclosures.
July 27, 2021
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Study supports shorter antibiotic course in men with UTI

Disclosures: Drekonja reports no relevant financial disclosures.
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A 7-day course of ciprofloxacin or trimethoprim/sulfamethoxazole for presumed, symptomatic UTI in afebrile men was noninferior to 14 days of treatment, a randomized trial showed.

To determine the optimal treatment duration for UTI in men, Dimitri M. Drekonja, MD, MS, an infectious disease physician and clinical researcher at the Minneapolis Veterans Affairs Health Care System, and colleagues reviewed data from 272 men (median age, 69 years) from two VA health clinics. All the participants were prescribed antibiotic therapy with ciprofloxacin or trimethoprim/sulfamethoxazole for 7 days. Half the men were then randomly assigned to continue with this same therapy, whereas the other half received placebo for days 8 through 14.

A 7-day course of ciprofloxacin or trimethoprim/sulfamethoxazole for presumed, symptomatic UTI in afebrile men was noninferior to 14 days of treatment, a randomized trial showed.
Reference: Drekonja DM, et al. JAMA. 2021;doi:10.1001/jama.2021.9899.

The primary analysis included data from men who took 26 or more of their 28 doses and missed no more than two consecutive doses (93.4%). A secondary analysis included data from all the men, regardless of treatment adherence.

Drekonja and colleagues wrote in JAMA that in the primary analysis, symptom resolution occurred in 93.1% of the men who took their prescribed therapy for 7 days and then received placebo compared with 90.2% of men who continued receiving antibiotic therapy for 14 days. The between-group difference was 2.9% (one-sided 97.5% CI, –5.2% to ), which met a prespecified 10% noninferiority margin.

According to the researchers, in the secondary analysis, symptom resolution occurred in 91.9% of the 7-day cohort compared with 90.4% in the 14-day cohort (between-group difference = 1.5%; one-sided 97.5% CI, –5.8% to ).

There was no significant difference in UTI symptom recurrence between groups, according to the researchers. About 20% of men in the 7-day cohort experienced adverse events compared with 24.3% in the 14-day cohort. The adverse events included warfarin dose interference, abnormal blood glucose levels, diarrhea, nausea, headache, dizziness, muscle or joint aches, tested for Clostridiodes difficile and allergy.

The researchers wrote that there were multiple reasons for limiting the therapies in their trial to ciprofloxacin and trimethoprim/sulfamethoxazole.

“At the time of study initiation, these agents accounted for 90% of treatment courses for UTI among ambulatory male patients in the VA,” Drekonja and colleagues wrote.

In addition, although other agents such as amoxicillin-clavulanate or nitrofurantoin are being increasingly used, the researchers noted that there is a paucity of data supporting these agents in male UTI; incorporating these therapies would have “introduced substantial heterogeneity” into the study cohort, and “would have posed additional barriers to achieving blinding, which relied on availability of the same agent but with a different appearance from the original, which would have been very challenging.”

Overall, the findings support the use of ciprofloxacin or trimethoprim/sulfamethoxazole for 7 days in afebrile men with presumed, symptomatic UTI, the researchers wrote.

In a related editorial, Daniel J. Morgan, MD, MS, and K. C. Coffey, MD, MPH, both professors of epidemiology and public health at the University of Maryland’s School of Medicine, wrote that since Drekonja and colleagues’ trial ended, the FDA has required packaging for ciprofloxacin, a fluoroquinolone, to contain a black box warning that indicates the risks for adverse events from its use “generally outweigh the benefits for patients with uncomplicated UTIs.”

The trial was also limited by its small sample size, and its “as-treated” design potentially “undermines the value of random allocation and risks confounding or bias,” Morgan and Coffey continued.

“Perhaps most important, the clinical definition of UTI used in the study included approximately one-third of patients without microbiologic evidence of UTI, which could bias results toward the null,” the authors added.

Noting that antibiotics are frequently prescribed for UTI without clinical evidence, Morgan and Coffey encouraged efforts to ascertain noninfectious UTI symptoms to “spare patients antibiotic exposure and adverse effects” tied to their use.

References:

Drekonja DM, et al. JAMA. 2021;doi:10.1001/jama.2021.9899.

Morgan DJ, Coffey KC. JAMA. 2021;doi:10.1001/jama.2021.11120.