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
1 other identifier
interventional
392
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2021
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 20, 2020
CompletedFirst Posted
Study publicly available on registry
January 30, 2020
CompletedStudy Start
First participant enrolled
January 4, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 25, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
April 4, 2024
CompletedOctober 3, 2024
March 1, 2024
3.2 years
January 20, 2020
October 1, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (9)
Time to resolution of symptoms
3-5 and 7-10 days post-enrolment
Caregiver satisfaction with testing
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
- +4 more secondary outcomes
Study Arms (2)
Rapid testing
EXPERIMENTALAbbott ID NOW Strep A testing.
Reference testing
ACTIVE COMPARATORCulture-based testing.
Interventions
Eligibility Criteria
You may qualify if:
- all those presenting who have a throat swab ordered for GAS testing
You may not qualify if:
- those who took antibiotics effective against GAS within 72 h of ED presentation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
McMaster Children's Hospital
Hamilton, Ontario, L8S 4K1, Canada
Related Publications (1)
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.
PMID: 34380724DERIVED
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 20, 2020
First Posted
January 30, 2020
Study Start
January 4, 2021
Primary Completion
March 25, 2024
Study Completion
April 4, 2024
Last Updated
October 3, 2024
Record last verified: 2024-03