Treatment and/or Prevention of Urinary Tract Infections

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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.