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7 days of treatment with ciprofloxacin or trimethoprim / sulfamethoxazole for suspected symptomatic UTIs in afebrile men were not inferior to 14 days of treatment, according to a randomized study.
To determine the optimal duration of treatment for urinary tract infections 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 (mean age 69 years) from two VA health clinics. All participants were prescribed 7 days of antibiotic therapy with ciprofloxacin or trimethoprim / sulfamethoxazole. Half of the men were then randomly assigned to continue the same therapy while the other half received placebo for days 8-14.
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 men, regardless of adherence.
Drekonja and colleagues wrote in JAMA that in the primary analysis, 93.1% of men who took their prescribed therapy for 7 days and then received a placebo had symptom resolution, compared with 90.2% of men who took 14 days received antibiotic therapy. The difference between the groups was 2.9% (one-sided 97.5% CI, –5.2% bis), which corresponded to a predefined non-inferiority margin of 10%.
According to the researchers, in the secondary analysis, symptoms resolved in 91.9% of the 7-day cohort, compared with 90.4% in the 14-day cohort (between the groups = 1.5%; one-sided 97.5 % CI, -5.8.). % to ).
According to the researchers, there was no significant difference in recurrence of UTI symptoms between the groups. Approximately 20% of the men in the 7-day cohort experienced adverse events compared to 24.3% in the 14-day cohort. Adverse events included an impairment in the dose of warfarin, abnormal blood sugar levels, diarrhea, nausea, headache, dizziness, muscle or joint pain, tested for clostridial difficile, and allergy.
The researchers wrote that there were several reasons for limiting the therapies in their study to ciprofloxacin and trimethoprim / sulfamethoxazole.
“At the time of the start of the study, these active ingredients made up 90% of the treatment cycles for urinary tract infections in male outpatients in the VA,” wrote Drekonja and colleagues.
In addition, although other drugs, such as amoxicillin clavulanate or nitrofurantoin, are increasingly being used, the researchers found that little data is available to support these drugs in male urinary tract infections; The inclusion of these therapies would have introduced “substantial heterogeneity” into the study cohort and “created additional barriers to achieving blinding based on the availability of the same active ingredient but with a different appearance than the original, which would have been very difficult. ”
Overall, the results support the use of ciprofloxacin or trimethoprim / sulfamethoxazole for 7 days in afebrile men with suspected symptomatic UTIs, the researchers wrote.
In a related editorial Daniel J. Morgan, MD, MS, and KC Coffey, MD, MPH, Both professors of Epidemiology and Public Health at the University of Maryland School of Medicine wrote that since the end of the study, the FDA has required Drekonja and colleagues to include a black box warning on the packaging of ciprofloxacin, a fluoroquinolone points out the risks for adverse events from its application “generally outweigh the benefits for patients with uncomplicated urinary tract infections”.
The study was also limited by its small sample size, and its “as-treated” design may undermine “the value of randomization and the risks that confuse or distort,” continued Morgan and Coffey.
“Perhaps most importantly, the clinical definition of UTIs used in the study included about a third of patients with no microbiological evidence of UTIs, which could skew the results toward zero,” the authors added.
Given that antibiotics are often prescribed without clinical evidence of UTIs, Morgan and Coffey encouraged efforts to identify non-infectious UTI symptoms in order to “spare patients antibiotic exposure and side effects” associated with their use.
References:
Drekonja DM et al. JAMA. 2021; doi: 10.1001 / jama.2021.9899.
Morgan DJ, Coffey KC. PIT. 2021; doi: 10.1001 / pit.2021.11120.
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