A Randomized, Open-label, Multi-Center, Prospective Study to Assess the Clinical Utility of TEM-PCR™ Upper Respiratory Panel in Adult Patients 65 and Older Presenting With Symptoms of Acute Respiratory Illness
试验速览
- 阶段
- 4 期
- 状态
- 暂停
- 入组人数
- 314
- 试验地点
- 8
- 主要终点
- Proportion of subjects with revisit to a healthcare facility
研究概览
简要总结
This is a randomized, open-label, multi-center, prospective study to assess the clinical utility of the TEM-PCR Upper Respiratory Infection (URI) Panel in adult subjects age 65 and older presenting to the primary care clinic with symptoms of acute respiratory illness.
详细描述
This is a randomized, open-label, multi-center, prospective study to assess the clinical utility of the TEM-PCR URI Panel in adult subjects age 65 and older presenting to the primary care clinic with symptoms of acute respiratory illness. The study will enroll 314 subjects with <10% of subjects having chronic conditions that may affect the lungs (i.e., CHF, COPD, and neoplastic disease of the lungs).
Subjects recruited from the general patient population visiting identified primary care clinic sites will be recruited and randomized to either TEM-PCR or Standard of Care (SOC)/empiric diagnosis for determination of respiratory pathogen(s). The treating physician will use the results of either the TEM-PCR panel or the SOC/empiric diagnosis to guide treatment decisions. Sputum sample (or nasopharyngeal swab if sputum sample cannot be collected) results obtained from the TEM-PCR diagnosis will be available in approximately one business day of sample collection. Sputum sample (or nasopharyngeal swab if sputum sample cannot be collected) results obtained from the SOC/empiric diagnosis will be available in approximately 3-5 business days of sample collection. The Investigator may call the subject upon receipt of sputum sample results if the results indicate that a change in therapy is necessary. All changes in the prescribed treatment plan will be documented in the subject's source documents. Subjects will record all therapy used for the treatment of respiratory illness and adverse events from Day 1 through Day 30 in a patient diary.
A final in-clinic visit will be conducted on Day 30 (± 5 days) following the Day 1 clinic visit to assess for outcomes (i.e., antibiotic treatment and duration/completion, use of antivirals and duration/completion, rate of clinic revisit or hospital admission and subsequent length of stay, mortality rate, use of steroids and/or antipyretics, use of OTC symptomatic treatments, and use of supportive therapy).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provide written informed consent for the trial;
- •Age 65 years or older;
- •In the opinion of the investigator, subject has the cognitive ability to provide accurate information to study site personnel and to follow instructions, or subject has a caregiver who can provide accurate information and ensure subject's compliance with instructions;
- •Presentation with at least two of the following symptoms of acute respiratory illness:
- •nasal congestion
- •chest congestion
- •shortness of breath
- •fever (≥100.4 ºF)
排除标准
- •Subject is currently taking antibiotics or has taken antibiotics within the previous 30 days.
- •Subject is currently taking antivirals or has taken antivirals within the previous 30 days.
- •Subject has been hospitalized within the previous 30 days.
- •Severity of illness (according to the Investigator) requires immediate hospitalization or referral to specialty care.
结局指标
主要结局
Proportion of subjects with revisit to a healthcare facility
时间窗: 30 days
The rate of revisit to a healthcare facility (i.e., revisit to primary care, urgent care, or hospital ER) for the same reason (respiratory infection) as the initial visit between subjects assigned to SOC/empiric diagnosis and TEM-PCR diagnosis as well as in a subset of subjects with bacterial superinfection
次要结局
- Proportion of subjects prescribed or continuing antibiotics for respiratory infection on the day of pathogen diagnosis(30 days)
- Total number of days of antibiotic use for respiratory infection during the follow-up period(30 days)
- Proportion of subjects prescribed antibiotics on Day 1 for respiratory infection(30 days)
- Use of supportive care (i.e., mechanical ventilation, addition of oxygen therapy or increase in oxygen use)(30 days)
- Proportion of subjects prescribed antivirals (i.e., oseltamivir, zanamivir, etc.) for respiratory infection on Day 1(30 days)
- Proportion of subjects prescribed or continuing antivirals for respiratory infection on the day of pathogen diagnosis(30 days)
- Clearance of respiratory infection at 30 days(30 days)
- Use (or increase in use) of steroids and/or antipyretics (acetaminophen/NSAIDs) for the treatment of respiratory illness(30 days)
- Use of OTC symptomatic treatment (i.e., antitussives, decongestants, and antihistamines) for the treatment of respiratory illness(30 days)
- Length of hospital stay for respiratory infection(30 days)
- Appropriateness of initial antibiotic selection for respiratory infection(30 days)
- Total number of days of antiviral use for respiratory infection during the follow-up period(30 days)
- Hospital admission for respiratory infection(30 days)
- Mortality from any cause within 30 days of Clinic visit(30days)
- Appropriateness of initial antiviral selection for respiratory infection(30 days)