Point of Care Group A Streptococcal Testing in a Pediatric Emergency Department: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 145
- 试验地点
- 2
- 主要终点
- Sore throat resolution.
研究概览
简要总结
Sore throat is a common problem in children typically caused by viral or bacterial infections. While viral infections resolve without treatment, bacterial infections, such as "strep throat," are treatable with antibiotics. Diagnosing "strep throat" traditionally required a throat swab for culture that delays treatment for several days. This may result in prolonged illness, activity absenteeism, and significant healthcare costs. New molecular tests can accurately diagnose "strep throat" within 8 minutes, but are more expensive and require impact evaluation before widespread implementation. This study will compare a new bedside molecular test with conventional throat cultures to evaluate for benefits to patients and families seen in the emergency department, as well to healthcare system operations. The investigators hypothesize that care for children and the associated healthcare costs will improve with these point of care molecular tests.
详细描述
Purpose:
Molecular-based, nucleic acid amplification tests (NAATs), have been proposed as a diagnostic solution for streptococcal pharyngitis. Indeed, available data suggest that NAATs have similar performance to conventional culture testing, and point of care (POC) NAATs recently became commercially available. These bedside tests do not require operation by laboratory personnel and have been approved by Health Canada for use without the need for backup culture testing. This study seeks to compare the clinical outcomes of a POC NAAT approach with a conventional bacterial culture-based approach for children presenting to a Pediatric Emergency Department (PED) with suspected streptococcal pharyngitis. Results from this clinical trial will elicit critical information regarding the potential clinical benefit of implementing this new technology in the PED.
Hypothesis:
The investigators hypothesize that clinical outcomes (duration of illness, incidence of complications, absenteeism) and system utilization (PED length of stay, ancillary testing, return visits to hospital or community healthcare facility, appropriate antibiotic treatment) will improve with a POC NAAT diagnostic approach for suspected streptococcal pharyngitis.
Justification:
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
- 3 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children 3-17 years of age who seek care in a ED with sore throat, and in whom the ED clinician is considering a throat swab for culture for suspected GAS pharyngitis. In addition, only English speaking families will be recruited.
排除标准
- •Patients younger than 3 and older than 17 years of age will be excluded. In addition, patients who had a throat swab completed and/or were treated with antibiotics prior to presenting to the ED for the current illness, and patients with underlying cardiorespiratory illness will be excluded.
结局指标
主要结局
Sore throat resolution.
时间窗: 7 days.
Mean time in half-days from ED discharge to sore throat resolution (POC vs. standard).
次要结局
- Parental Absenteeism.(7 days.)
- Calls averted.(7 days.)
- Fever resolution.(7 days.)
- Appropriate antibiotic utilization by patients/families.(7 days.)
- Child Absenteeism(7 days)
- Healthcare return visits.(7 days.)
- Ancillary testing.(7 days)
- Length of stay.(7 days.)
研究者
Quynh Doan
Assistant Professor
University of British Columbia