According to the results of a randomized, double-blind trial, seven days of antibiotic therapy for afebrile men with suspected urinary tract infections (UTI) was as effective as a 14-day regimen.
In more than 250 men with a suspected symptomatic UTI included in the analysis as treated, resolution of symptoms 14 days after the end of antibiotic treatment occurred in 93.1% of the 7-day group versus 90.2 % of 14-day group – a difference of 2.9%, which met the 10% non-inferiority criterion, reported Dimitri Drekonja, MD, of the Minneapolis Veterans Affairs Health Care System, and colleagues at JAMA.
In the secondary randomized analysis of more than 270 men, resolution of symptoms occurred in 91.9% of participants in the 7-day group versus 90.4% in the 14-day group, a difference of 1.0. 5%.
“The results support the use of a 7-day course of ciprofloxacin or trimethoprim / sulfamethoxazole as an alternative to a 14-day course for the treatment of afebrile men with urinary tract infection,” the authors concluded.
“Shorter antibiotic treatments are inherently easier on patients and are preferred when clinical outcomes are not inferior to those with a longer treatment duration,” wrote Daniel Morgan, MD, and KC Coffey, MD, MPH , both from 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 give clinicians the confidence to treat thoughtfully for the shortest effective treatment duration.”
Shorter course antibiotics have been shown to be as effective as long term treatment for infections such as pneumonia, intra-abdominal infections, osteomyelitis, cellulitis and urinary tract infections in women, and represents therefore an important strategy to preserve the effectiveness of these drugs, noted Drekonja and colleagues.
In the case of UTIs in men, the evidence is mixed regarding the optimal duration of treatment. Therefore, in order to determine whether afebrile men with urinary tract infection could benefit from a shorter course of treatment, the authors conducted a placebo-controlled non-inferiority trial of antibiotic therapy for 7 versus 14 days of treatment. April 2014 to December 2019.
The trial included 272 patients from two US VA medical centers who used the antibiotic prescribed by their treating clinician for 7 days and were then randomized 1: 1 to receive continuous antibiotic therapy or placebo for days 8-14. The team limited their investigation to ciprofloxacin. and trimethoprim / sulfamethoxazole since these drugs represented 90% of treatments for AV patients at the time.
The patients had a median age of 69 years 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 in the group.
Of the patients included, 254 were considered part of the treated population (participants who took at least 26 of 28 doses and did not miss more than two consecutive doses) and were used for the main analysis.
The primary outcome – resolution of UTI symptoms by day 14 after cessation of antibiotic treatment – occurred in 233 of 254 patients in the as-treated population (91.7%) and in 248 of 272 (91.2%) patients from the randomized population. population.
The reported recurrence of UTI symptoms was similar between the two groups in the as-treated population (9.9% in the 7-day group vs. 12.9% in the 14-day group; P= 0.70) and the randomized population (10.3% and 16.9%, respectively; P= 0.20).
Of the patients in the as-treated population who reported adverse events – primarily diarrhea, nausea, and abnormal blood glucose readings – 19.8% were in the 7-day group and 23.6% were in the 14-day group. days. For the randomized group, these proportions were 20.6% and 24.3% respectively.
Morgan and Coffey noted that since the start of the study, the FDA began requiring a black box warning on ciprofloxacin, indicating that the potential for serious adverse events outweighs its benefits in treating infections. uncomplicated urinary tract, which was a limitation of the study.
In addition, they stated that the clinical definition of UTI used in the study allowed the enrollment of approximately one-third of patients without microbiological evidence of UTI, “which could bias the results towards zero.”
“Antibiotics are frequently prescribed to patients with dysuria, frequency, hematuria, and even non-localized symptoms in the urinary tract such as altered mental state and general malaise,” the editorialists wrote. “Practice should evolve to better identify non-infectious symptoms and spare patients exposure to antibiotics and side effects, although little progress has been made to date, as evidenced by overtreatment of asymptomatic bacteriuria.”
The study was funded by the VA Merit Review Program and supported in part by a grant from the Houston VA Health Services Research & Development Center for Innovations in Quality, Effectiveness, and Safety.
Drekonja did not report any disclosures.
The co-authors reported relationships with the industry.
Morgan reported grants from the US Department of Veterans Affairs, the Agency for Healthcare Research and Quality, and the CDC outside of the submitted work. Coffey did not report any disclosures.