Seven vs. 14 Days Treatment for Male Urinary Tract Infection

描述(由申请人提供)： 这项拟议的研究是一项关于男性尿路感染(UTI)治疗时间的随机安慰剂对照试验。具体来说，319名有尿路感染的男性将被随机分为7天和14天 抗菌治疗的结果。主要结果是尿路感染症状的缓解，在完成积极的抗菌治疗后14天进行评估。次要结果包括治疗后4周内尿路感染复发、药物不良反应和肠道携带抗菌素耐药革兰氏阴性杆菌。受试者将从明尼阿波利斯退伍军人医疗中心(MVAMC)的初级保健诊所和急诊科登记。目前，男性尿路感染的最佳治疗时间尚不清楚。治疗14天和28天的临床试验结果没有差异，而另一项治疗3天和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尿路感染7至14天，没有数据支持较短或较长的持续时间。大多数在退伍军人病区患有尿路感染的男性接受治疗的时间超过7天，这与艰难梭菌感染的少量但显著增加有关。此外，对非尿路感染传染病的其他研究表明，较长的疗程会导致抗菌素耐药性的增加。持续时间更长的治疗也更昂贵，对患者来说也不方便。因此，由于较长时间的治疗与一些不良后果相关，为了证明较长时间的治疗是合理的，那么延长治疗必须在临床上有显著的益处。因此，这项针对319名男性尿路感染患者的随机安慰剂对照试验将检验这样一种假设，即与14天的治疗相比，7天的抗菌治疗在缓解尿路感染症状方面并不逊色。这项研究将为VA患者和临床医生提供关于常见的和未被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.