SBIR Phase II: Development of a urine dipstick test that can guide immediate and appropriate antibiotic therapy for treatment of complicated urinary tract infections

小型企业创新研究(SBIR)第二阶段项目的更广泛影响/商业潜力是改善复杂性尿路感染(CUTI)患者的临床结果和生活质量。今天，在美国，每年有40万人因皮肤病住院。不幸的是，多药耐药病原体是cUTI的常见原因。许多人对一线抗生素(头孢曲松)具有耐药性，头孢曲松是这种疾病的经验性治疗方法。然而，引起cUTI的多重耐药病原体的高发病率推迟了时间，直到患者接受更适当的治疗。CUTI的适当治疗时间延迟是由于住院时间延长以及发病率和死亡率增加。目前诊断耐药cUTI的标准测试需要2-3天才能获得患者样本。因此，迫切需要能够为尿路感染的初始治疗提供快速信息的诊断测试，以改善患者的护理。这项小型企业创新研究(SBIR)第二阶段项目旨在开发一种快速尿路诊断测试，使对头孢曲松耐药的尿路病原体能够被检测出来。及早发现对一线治疗的耐药性将使抗生素处方能够得到通知，从而降低患者疾病进展的风险。在尿路感染的情况下，疾病的进展可导致严重的侵袭性感染，主要是败血症。因此，能够检测出对一线抗生素的耐药性的诊断方法使早期治疗干预成为可能，从而缩短适当治疗的时间并降低疾病进展的风险。治疗时间的减少也降低了与耐药cUTI相关的医疗成本，因为与易感感染相比，疾病进展与住院时间的延长有关。第二阶段项目的完成将产生一种原型测试的开发，该测试可以在不到5分钟的时间内提供有关头孢曲松敏感性的可行信息。该项目的成功将为临床医生提供一种皮肤炎症性疾病的诊断解决方案，该解决方案可以立即采取行动，通过防止不必要的不适当抗生素的使用来改善患者的预后并帮助抗生素管理。该奖项反映了NSF的法定使命，并通过使用基金会的智力价值和更广泛的影响审查标准进行评估，被认为值得支持。

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase II project is to improve the clinical outcomes and quality of life for patients suffering from complicated urinary tract infections (cUTI). Today, cUTIs account for 400,000 hospitalizations annually in the United States. Unfortunately, multidrug resistant pathogens are a common cause of cUTI. Many are resistant to the first-line antibiotic (Ceftriaxone), which is used as the empiric treatment of this condition. However, the high incidence of multidrug resistant pathogens causing cUTI delays the time until patients receive more appropriate treatment. Delayed time to appropriate therapy in cUTI has been attributed to extended hospital stays and an increased risk of morbidity and mortality. The current standard test for diagnosing a drug-resistant cUTI takes 2-3 days from obtaining a patient sample. Therefore, diagnostic tests that can rapidly inform the initial treatment of UTIs are urgently needed to improve patient care.This Small Business Innovation Research (SBIR) Phase II project aims to develop a rapid urinary diagnostic test that will enable the detection of ceftriaxone-resistant uropathogens. Early detection of resistance to first-line therapies would enable antibiotic prescribing to be informed, reducing the risk of disease progression in patients. In the case of UTIs, disease progression can lead to severely invasive infections, predominately sepsis. Therefore, diagnostics that can detect resistance to first-line antibiotics enable early treatment interventions, reducing the time to appropriate treatment and reducing the risk of disease progression. Decreased treatment time also lowers the healthcare costs associated with drug-resistant cUTI, as disease progression is associated with increased lengths of hospital stays compared to susceptible infections. The completion of the Phase II project will yield the development of a prototype test that can provide actionable information regarding ceftriaxone susceptibility in less than 5 minutes. This project’s success will provide clinicians with a diagnostic solution for cUTIs that can be acted on immediately to improve patient outcomes and aid antibiotic stewardship by preventing the unnecessary use of inappropriate antibiotics.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.