Streptococcal Pharyngitis
Conditions
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.
Interventions
DEVICERapid testing
Abbott ID NOW Strep A testing
DIAGNOSTIC_TESTReference testing
Culture-based testing
Sponsors
Hamilton Health Sciences Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Years to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Caregiver satisfaction with testing | 3-5 days post-enrolment | Likert scale |
| 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 | — |
| Time to resolution of symptoms | 3-5 and 7-10 days post-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 | at enrolment | Time from consent to discharge from the ED |
| 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. |
Countries
Canada
Outcome results
None listed