Rapid POC GAS Diagnostics in the Paediatric ED

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

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.

Study Overview

• Status: Completed
• Conditions: Streptococcal Pharyngitis
• Intervention / Treatment: Device: Rapid testing; Diagnostic test: Reference testing

• Study Type: Interventional
• Enrollment (Actual): 392
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8S 4K1
      • McMaster Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Rapid testing; Abbott ID NOW Strep A testing.	Device: Rapid testing; Abbott ID NOW Strep A testing
Active Comparator: Reference testing; Culture-based testing.	Diagnostic test: Reference testing; Culture-based testing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Appropriate antibiotic treatment	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.'	3-5 days post-enrolment

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hamilton Health Sciences Corporation

Publications and helpful links

General Publications

• Pernica JM, Smaill F, Kam AJ, Bartholomew A, Doan Q, Smieja M, Khan S, Sung M, Thabane L, Goldfarb DM. Single-centre, open-label, randomised, trial to compare rapid molecular point-of-care streptococcal testing to standard laboratory-based testing for the management of streptococcal pharyngitis in children: study protocol. BMJ Open. 2021 Aug 11;11(8):e047271. doi: 10.1136/bmjopen-2020-047271.

Study record dates

Study Major Dates

• Study Start (Actual): January 4, 2021
• Primary Completion (Actual): March 25, 2024
• Study Completion (Actual): April 4, 2024

Study Registration Dates

• First Submitted: January 20, 2020
• First Submitted That Met QC Criteria: January 28, 2020
• First Posted (Actual): January 30, 2020

Study Record Updates

• Last Update Posted (Actual): October 3, 2024
• Last Update Submitted That Met QC Criteria: October 1, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Pharyngitis
• Other Study ID Numbers: HAHSO POC GAS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes