Rapid POC GAS Diagnostics in the Paediatric ED

Hamilton Health Sciences Corporation392 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

392

Conditions

Streptococcal Pharyngitis

Interventions

Rapid testingDEVICE

Abbott ID NOW Strep A testing

Reference testingDIAGNOSTIC_TEST

Culture-based testing

Eligibility

Sex: ALLMin age: 3 YearsMax age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

McMaster Children's Hospital

Hamilton, Ontario, Canada

Outcomes

Primary Outcomes

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.'

Time frame: 3-5 days post-enrolment

Secondary Outcomes

Time to resolution of symptoms

Time frame: 3-5 and 7-10 days post-enrolment

Caregiver satisfaction with testing

Likert scale

Time frame: 3-5 days post-enrolment

Number of days of missed school/daycare

Time frame: 3-5 and 7-10 days post-enrolment

Number of days of missed work (caregiver)

Time frame: 3-5 and 7-10 days post-enrolment

Number of healthcare visits for pharyngitis or sinopulmonary infections

Time frame: 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.

Time frame: At enrolment

Data from ClinicalTrials.gov

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