Treatment and/or Prevention of Urinary Tract Infections

尿路感染的治疗和/或预防

基本信息

批准号：
7538517
负责人：
BARBARA Wells TRAUTNER
金额：
$ 22.67万
依托单位：
BIOMEDICAL DEVELOPMENT CORPORATION
依托单位国家：
美国
项目类别：
财政年份：
2008
资助国家：
美国
起止时间：
2008-09-15 至 2010-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7538517
关键词：
Accounting Acute Acute Cystitis Adopted Affect Age Antibiotic Therapy Antibiotics Antimicrobial Resistance Bacteria Bacterial Infections Biometry Budgets Caring Catheters Clinical Clinical Research Clinical Treatment Clinical Trials Communicable Diseases Communities Count Cystitis Development Diagnosis Doctor of Medicine Doctor of Philosophy Drug Formulations Escherichia coli Evaluation Goals Government Grant Guanosine Monophosphate Healthcare Hospitals Human Indwelling Catheter Infection Investigational Drugs Investigational New Drug Application Iodine Lead Legal patent Medicine Microbiology Nosocomial Infections Numbers Oral Oral mucous membrane structure Patients Persons Pharmaceutical Chemistry Pharmaceutical Preparations Pharmacologic Substance Phase Phase I Clinical Trials Prevention Prevention strategy Preventive Principal Investigator Public Health Purpose Recurrence Research Personnel Resistance Resistance development Science Statistically Significant Symptoms System Testing Treatment Efficacy Trimethoprim-sulfamethoxazole drug resistance United States Centers for Medicare and Medicaid Services United States Food and Drug Administration Urinary tract infection Urine Uropathogen Visit Woman antimicrobial base catheter associated UTI college community-acquired UTI cost experience fluoroquinolone resistance hatching human study innovation microbial nosocomial UTI novel pathogen payment prevent response urinary

项目摘要

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.

描述（由申请人提供）：尿路感染（UTI）是每年影响数百万人的非常常见的细菌感染。在美国，大约10％的妇女每年被诊断出患有膀胱炎，相关成本为16亿美元。 UTI也是最常见的医院感染，医院UTI主要是由于留置尿导管而产生的。尽管通常通过抗生素疗法有效地治疗UTI，但尿道病的抗药性出现变得越来越普遍，并已发展成为影响UTI管理的最重要因素之一。该项目的目的是开发一种新型产品，用于治疗和/或预防尿路感染，而尿路感染不太可能引起微生物抗性。在以前的人类研究中，该产品已被证明是安全的。第一阶段的研究将着重于完成联邦监管要求，包括在质量系统中生产该产品并向FDA提交研究新药申请。在FDA接受IND之后，将在急性，简单UTI治疗的临床试验中对该治疗进行测试。该提案的具体目的是：目标1。研究性新药目标的完全调节要求2。公共卫生相关性泌尿道感染（UTI）是第二常见的人类感染类型，每年影响数百万。 UTI每年约有730万医生就诊。估计有1分之一的女性将至少有一个UTI需要到24岁。在她们的一生中，一半以上的女性会感染一半，并且这些感染通常会经常发生。由于对当前抗生素治疗的微生物耐药性的增加，需要一种新的治疗和/或预防UTI治疗的疗法。预防和治疗不鼓励微生物抗性的代理商会对公共卫生产生重大影响。