Treatment and/or Prevention of Urinary Tract Infections

描述(申请人提供)：尿路感染(UTI)是一种非常常见的细菌感染，每年影响数百万人。在美国，每年约有10%的女性被诊断为膀胱炎，相关成本为16亿美元。尿路感染也是最常见的医院感染，医院内尿路感染大多是留置导尿管的结果。虽然尿路感染一般可以通过抗生素治疗得到有效的治疗，但尿路病原菌之间的耐药性的出现正变得越来越常见，并已发展成为影响尿路感染治疗的最重要因素之一。该项目的目标是开发一种治疗和/或预防尿路感染的新产品，该产品不太可能导致微生物耐药性。在之前的人体研究中，该产品已被证明是安全的。第一阶段的研究将集中于完成联邦监管要求，包括在质量体系中制造产品，并向FDA提交调查性新药申请。在FDA接受IND后，该治疗将在治疗急性、简单尿路感染的临床试验中进行测试。该提案的具体目标是：目标1.对正在研究的新药的完整法规要求2.在膀胱炎的人体临床试验中评估该治疗的疗效 公共卫生相关性 尿路感染(UTI)是第二种最常见的人类感染类型，每年影响数百万人。尿路感染每年约有730万人次就诊。据估计，每3名妇女中就有1人在24岁之前至少有一次尿路感染需要抗菌治疗。在她们的一生中，超过一半的女性会有尿路感染，而且这些感染往往是反复发生的。由于微生物对当前抗生素治疗的耐药性增加，需要一种新的疗法来治疗和/或预防尿路感染。一种预防和治疗尿路感染的药物如果不鼓励微生物产生耐药性，将对公众健康产生重大影响。

DESCRIPTION (provided by applicant): Urinary tract infections (UTIs) are very common bacterial infections that affect millions of people each year. In the U.S., approximately 10% of women are diagnosed with cystitis annually, with an associated cost of $1.6 billion. UTIs are also the most commonly occurring nosocomial infection, and nosocomial UTIs mostly arise as a consequence of indwelling urinary catheters. Although UTIs are generally effectively treated with antibiotic therapy, the emergence of resistance among uropathogens is becoming more common and has developed into one of the most important factors impacting the management of UTIs. The goal of this project is to develop a novel product for the treatment and/or prevention of urinary tract infections that is unlikely to induce microbial resistance. The product has been shown to be safe in previous human studies. Phase I studies will focus on completing federal regulatory requirements including manufacturing the product in a quality system and submitting an Investigational New Drug application to the FDA. Subsequent to the acceptance of the IND by the FDA, the treatment will be tested in a clinical trial of treatment of acute, uncomplicated UTI. The Specific Aims of the proposal are: Aim 1. Complete Regulatory Requirements for an Investigational New Drug Aim 2. Evaluate Efficacy of the Treatment in a Human Clinical Trial of Cystitis PUBLIC HEALTH RELEVANCE Urinary tract infections (UTIs) are the second most common type of human infection and affect millions of people each year. UTIs account for about 7.3 million doctor visits annually. An estimated 1 in 3 women will have at least one UTI requiring antimicrobial treatment by the age of 24. During their lifetimes, more than half of all women will have a urinary infection, and these infections are often recurrent. A new therapy to treat and/or prevent UTIs is needed due to increased microbial resistance to current antibiotic treatments. An agent to prevent and treat UTI that does not encourage microbial resistance would have a significant impact on public health.