Urinary Tract Infection: RapID Molecular Organism Identification and Mixed Flora Antibiotic Resistance Profiling (MixAR)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pathnostics
- 入组人数
- 2,511
- 试验地点
- 2
- 主要终点
- Establish Safety: composite adverse event rate
研究概览
简要总结
In this protocol, investigators are examining the ability for a novel multiplex PCR assay with mixed floral antibiotic resistance profiling is safe and increases effective treatment for urinary tract infections in a urology clinic over traditional culture methods alone and decreases retreatment rates in this population.
详细描述
The novel multiplex real-time PCR assay with mixed floral antibiotic resistance profiling offers a higher degree of sensitivity and specificity than conventional culture methods in the identification of UTI pathogens as determined by the previous prospective comparison study. Additionally, conventional methods are often inadequate in the case of polymicrobial infections. More accurate and timely pathogen identification allows for prompt and more targeted treatment with less reliance on empiric therapy and decreased rates of antibiotic therapy changes and retreatment. This leads to more favorable patient outcomes and decreases the development of resistant organisms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Diagnostic
- 盲法
- Single (Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• Patient Informed Consent form completed
- •Male and Female Subjects may participate with no predetermined quotas or ratios for gender participation.
- •All patients must be ≥60 years old. For patients presenting with a diagnosis of interstitial cystitis, patients may be of any age.
- •Patients must be presenting for treatment of acute UTI, complicated UTI, persistent UTI, or recurrent UTI's.
- •Including prostatitis, pyelonephritis, and/or interstitial cystitis.
- •Data pertaining to the times at which the specimen samples are collected and stabilized needs to be documented.
- •Specimen samples obtained need to have a sufficient volume necessary to perform a urine culture and Guidance 4.0.
排除标准
- •• Do not provide written informed Consent with HIPAA authorization form.
- •Taking antibiotics for any reason other than UTI at the time of enrollment
- •Patients with chronic (> 10 days) indwelling catheters
- •Self-catheterized patients
- •Patients with neobladders
结局指标
主要结局
Establish Safety: composite adverse event rate
时间窗: 7 Days
Demonstrate safety of Guidance 4.0 multiplex real-time PCR organism identification with mixed floral antibiotic resistance profiling guided treatment. Safety will be measured with a composite adverse event outcome of urosepsis, pyelonephritis, hospitalization, or the need to attend an urgent care center. The composite adverse event rate in the arm tested with Guidance 4.0 will be shown to be non-inferior to that in the arm tested with traditional urine culture. Superiority will also be tested.
次要结局
- Time to Symptom Resolution in Each Arm(7 days)
- Number of Patients with Recurrent and Persistent Infections in Each Arm(7 Days)