Rapid POC GAS Diagnostics in the Paediatric ED

Study Overview
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Brief Summary
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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.

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

Conditions
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Streptococcal Pharyngitis

Intervention / Treatment
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* Device: Rapid testing
* Diagnostic Test: Reference testing


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rapid testing<br>Abbott ID NOW Strep A testing. | Device: Rapid testing<br>* Abbott ID NOW Strep A testing<br>|
| Active Comparator: Reference testing<br>Culture-based testing. | Diagnostic Test: Reference testing<br>* Culture-based testing<br>|

What is the study measuring?
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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 |