Rapid POC GAS Diagnostics in the Paediatric ED

Not Applicable

Completed

• Conditions: Streptococcal Pharyngitis
• Interventions: Device: Rapid testing; Diagnostic Test: Reference testing

• Registration Number: NCT04247243
• Lead Sponsor: Hamilton Health Sciences Corporation

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-01-20
• Study First Submitted QC: 2020-01-28
• Study First Posted: 2020-01-30
• Study Start: 2021-01-04
• Status Verified: 2024-03
• Primary Completion: 2024-03-25
• Study Completion: 2024-04-04
• Last Update Submitted: 2024-10-01
• Last Update Posted: 2024-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 392

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rapid testing	Rapid testing	Abbott ID NOW Strep A testing.
Reference testing	Reference testing	Culture-based testing.

Primary Outcome Measures

Name	Time	Method
Appropriate antibiotic treatment	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.'

Secondary Outcome Measures

Name	Time	Method
Caregiver satisfaction with testing	3-5 days post-enrolment	Likert scale
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	The MD who clinically assessed the patient and who later discharged the patient home will be asked - if the participant was randomized to rapid testing - whether the testing was helpful. (The outcome will be ordinal on a Likert scale). If the participant was randomized to standard testing, they will be asked how helpful NOT having rapid testing was, again measured on the same Likert scale.
Time required to utilize point-of-care testing	at enrolment	Time from consent to discharge from the ED
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

Trial Locations

Locations (1)

McMaster Children's Hospital; 🇨🇦 Hamilton, Ontario, Canada