Seven vs. 14 Days Treatment for Male Urinary Tract Infection

描述（由申请人提供）： 拟定的研究是一项关于男性尿路感染（UTI）治疗持续时间的随机安慰剂对照试验。具体而言，319名UTI男性将随机分为7天和14天 进行抗菌治疗。主要结局是UTI症状的消退，在完成积极的抗菌治疗后14天进行评估。次要结局包括治疗后4周内复发性UTI、药物不良事件和肠道携带耐药革兰氏阴性杆菌。受试者将从明尼阿波利斯VA医疗中心（MVAMC）的初级保健诊所和急诊科入组。目前，男性UTI的最佳治疗持续时间尚不清楚。一项治疗14天与28天的临床试验显示结局无差异，而另一项治疗3天与14天的临床试验显示治疗3天后复发率增加。然而，目前的治疗建议是治疗男性UTI 7至14天，没有数据支持更短或更长的持续时间。大多数患有VA中UTI的男性接受超过7天的治疗，这与艰难梭菌感染的小幅但显著增加有关。此外，其他非UTI感染性疾病的研究表明，较长时间的治疗会导致抗生素耐药性增加。较长时间的治疗对患者来说也更昂贵和不方便。因此，由于长期治疗与一些不良结局相关，为了证明长期治疗的合理性，必须证明延长治疗的临床显著获益。因此，拟定的319例UTI男性患者的随机安慰剂对照试验将检验以下假设：与14天治疗相比，7天抗菌药物治疗在UTI症状消退方面具有非劣效性。这项研究将为VA患者和临床医生提供有关常见和未充分研究的临床决策的有价值的信息。

DESCRIPTION (provided by applicant): The proposed study is a randomized placebo-controlled trial of treatment duration for male urinary tract infection (UTI). Specifically, 319 men with a UTI will be randomized to 7 vs. 14 days of antimicrobial treatment. The primary outcome is resolution of UTI symptoms, assessed 14 days after completing active antimicrobial treatment. Secondary outcomes include recurrent UTI in the 4 weeks after treatment, adverse drug events, and intestinal carriage of antimicrobial resistant Gram-negative bacilli. Subjects will be enrolled from the Primary Care Clinic and Emergency Department at the Minneapolis VA Medical Center (MVAMC). Currently, the optimal treatment duration for male UTI is unknown. A clinical trial of 14 vs. 28 days of treatment showed no difference in outcomes, whereas another trial of 3 vs.14 days showed an increase in recurrence with 3 days of treatment. However, current treatment recommendations are to treat men with UTI for 7 to 14 days, and no data exist to favor the shorter or longer duration. Most men with UTI in the VA are treated for more than 7 days, which is associated with a small but significant increase in Clostridium difficile infection. Additionally, other studies of non-UTI infectious diseases have shown that longer-duration treatment leads to increased antimicrobial resistance. Longer- duration treatment is also more costly and inconvenient to patients. Thus, since longer-duration treatment is associated with some adverse outcomes, in order to justify longer-duration treatment thee must be some clinically significant benefit to the extended treatment. Accordingly, the proposed randomized placebo-controlled trial of 319 men with UTI will test the hypothesis that 7 days of antimicrobial treatment is non-inferior for the resolution f UTI symptoms when compared to 14 days of treatment. This study will provide valuable information to VA patients and clinicians regarding a common and understudied clinical decision.