Clinical Significance of Real Time PCR Panel in Children With Acute Gastrointestinal Symptoms
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 526
- 主要终点
- Impact on clinical decision making
研究概览
简要总结
This investigator-initiated randomized controlled trial compares the clinical impact of real time PCR of fecal samples in children with acute gastrointestinal symptoms at a pediatric emergency room. Specifically, the trial compares immediate testing of fecal samples using a multiplex PCR panel to a a control group with delayed test results.
详细描述
Acute gastroenteritis is one of the most common reasons for pediatric emergency visits in both general and pediatric emergency departments. For most of the children rehydration is the only therapy needed. However, a range of bacterial pathogens and parasites may need accurate diagnosis and targeted antimicrobial therapy. Use of molecular multiplex testing has increased detection of pathogens in children with acute gastrointestinal symptoms. The PCR tests currently available enable rapid identification of gastrointestinal pathogens, with the test results often being available during the day sample was taken. However, it is unclear which of the patients are most likely to benefit from testing. Also, there is considerable uncertainty about the cost-effectiveness of the multiplex panels used to test for suspected infectious gastroenteritis in hospital and community settings. The previous study by the research group demonstrated that acute gastrointestinal symptoms are one of the most common diagnoses and a major cost in high-income population.
The main hypothesis of the study is that real time multiplex PCR testing for gastrointestinal pathogens at pediatric emergency department setting could provide clinical benefit by allowing 1) earlier initiation of appropriate antimicrobial treatment, 2) reduce use of unnecessary antimicrobial treatment and 3) improve identification of conditions in need for follow-up.
To estimate the usefulness of real time multiplex PCR testing, an investigator-driven academic randomized (1:1) controlled trial will be conducted at the Pediatric Emergency Department of Oulu University Hospital, Finland. For eligibility, children aged under 16 years arriving to pediatric emergency due to acute gastrointestinal symptoms will be assessed. After obtaining the written consent, fecal specimens will be collected by the nurses from the first stool after arriving to hospital.
Multiplex PCR detects 13 gastrointestinal bacterial pathogens, 5 viral pathogens ands 4 parasitic species. QIAStat-Dx gastrointestinal panel 2 will be used.
The trial will compare two groups:
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
- — 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Child or adolescent < 16 years of age
- •Visiting pediatric ED
- •Presence of gastrointestinal symptom or symptoms (diarrhea, vomiting or abdominal pain)
排除标准
- •Need of cardiopulmonary resuscitation at the ED
- •Need of immediate transfer to the intensive care unit
- •Hemato-oncological disease
- •Severe immunosuppression
- •Bloody diarrhea
- •Clinical suspicion of typhoid/paratyphoid fever
结局指标
主要结局
Impact on clinical decision making
时间窗: 72 hours from initial contact at the ED
Primary outcome comprises the proportion of participants with 1) targeted antimicrobial therapy based on PCR results 2) untargeted antimicrobial therapy avoided based on PCR result, OR 3) specific clinical follow up planned based on PCR result, namely EHEC infection
次要结局
- Proportion of children needing hospitalization or specific follow up(72 hours from initial contact at the ED)
- Surgical operation(72 hours from the initial presentation)
- Total cost of treatment(30 days from the initial presentation)
- Need for a surgical consultation(72 hours from initial presentation)
- Time to correct diagnosis(30 days from the initial presentation at the ED)
- Time to resolution of symptoms(28 days)
- Proportion of children with correctly targeted antimicrobial therapy(72 hours from initial contact at the ED)
- The overall cost of diagnostic procedures(72 hours from the initial contact)
- Revisit at the ED(30 days)
- Correct hospital isolation measures(72 hours from initial presentation)
- Time to receive the laboratory results(7 days from the initial presentation to the ED)
- Length of stay(30 days from the presentation to the ED)
- Correct use of personal protective equipment(72 hours from the initial presentation)
- Pediatric infectious diseases consultation(72 hours after the initial presentation at the ED)