Amundson Carla, Johnson James, Trautner Barbara, Drekonja Dimitri
Minneapolis Veterans Affairs Health Care System, 1 Veterans Drive, Mail Code 111F, Minneapolis, MN, 55417, USA.
University of Minnesota Medical School, 420 Delaware St SE, Minneapolis, MN, 55455, USA.
Contemp Clin Trials Commun. 2021 Jan 16;21:100714. doi: 10.1016/j.conctc.2021.100714. eCollection 2021 Mar.
The optimal treatment duration for men with urinary tract infection (UTI) is poorly defined. Observational data suggests that shorter-duration therapy may perform as well as longer-duration therapy, but trial data are lacking. We present the protocol and methods for a Department of Veterans Affairs-funded trial of seven vs. 14 days of antimicrobial therapy for afebrile men with UTI, with the primary outcome of symptom resolution 14 days after completing active antimicrobial treatment. An optional sub-study will investigate the effect of treatment duration on the intestinal carriage of antimicrobial-resistant microorganisms. Subjects are enrolled after their UTI is diagnosed and treatment initiated, using a combination of in-person and mail enrollment to maximize participation and minimize resource utilization. This trial will provide high-quality evidence to guide the management of a common infectious disease and potentially limit unnecessary antimicrobial use.
对于男性尿路感染（UTI）患者的最佳治疗时长尚无明确定义。观察性数据表明，较短疗程的治疗效果可能与较长疗程相当，但缺乏试验数据。我们介绍了一项由美国退伍军人事务部资助的试验方案和方法，该试验针对无发热的男性UTI患者，比较7天与14天抗菌治疗的效果，主要结局是完成积极抗菌治疗14天后症状缓解。一项可选的子研究将调查治疗时长对耐抗菌微生物肠道携带情况的影响。在UTI确诊并开始治疗后招募受试者，采用当面和邮寄相结合的招募方式，以最大限度地提高参与度并减少资源利用。这项试验将提供高质量证据，以指导一种常见传染病的管理，并可能限制不必要的抗菌药物使用。
