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临床试验/NCT04247243
NCT04247243已完成不适用

Streamlining Care Delivery in the Paediatric Emergency Department Using Rapid Point-of-care Diagnostics for Group a Streptococcus: a Randomized Controlled Trial

Hamilton Health Sciences Corporation2 个研究点 分布在 1 个国家目标入组 392 人开始时间: 2021年1月4日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
392
试验地点
2
主要终点
Appropriate antibiotic treatment

研究概览

简要总结

Randomized trial evaluating effectiveness of rapid point-of-care molecular GAS diagnostics as compared to standard culture-based techniques for the management of children aged 3-18 years of age presenting with sore throat to McMaster Children's Hospital Emergency Department.

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 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • all those presenting who have a throat swab ordered for GAS testing

排除标准

  • those who took antibiotics effective against GAS within 72 h of ED presentation

结局指标

主要结局

Appropriate antibiotic treatment

时间窗: 3-5 days post-enrolment

All participants will be contacted by phone to ascertain whether they took antibiotics for the treatment of streptococcal pharyngitis. 'Appropriate antibiotic treatment' is a dichotomous measure. If the participant's throat swab was positive for GAS and they took antibiotics, or if their throat swab was negative for GAS and they did NOT take antibiotics, antibiotic treatment will be deemed 'appropriate.' All other scenarios will be deemed not 'appropriate.'

次要结局

  • Caregiver satisfaction with testing(3-5 days post-enrolment)
  • Number of days of missed work (caregiver)(3-5 and 7-10 days post-enrolment)
  • Proportion of point-of-care GAS tests that are uninterpretable(at enrolment)
  • Number of days of missed school/daycare(3-5 and 7-10 days post-enrolment)
  • ED MD satisfaction with testing(At enrolment)
  • Time required to utilize point-of-care testing(at enrolment)
  • Number of healthcare visits for pharyngitis or sinopulmonary infections(7 days post-enrolment)
  • Number of household contacts subsequently diagnosed with GAS pharyngitis(7-10 days post-enrolment)
  • Time to resolution of symptoms(3-5 and 7-10 days post-enrolment)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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