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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rapid testing | Experimental | Abbott ID NOW Strep A testing. |
|
| Reference testing | Active Comparator | Culture-based testing. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rapid testing | Device | Abbott ID NOW Strep A testing |
| |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| McMaster Children's Hospital | Hamilton | Ontario | L8S 4K1 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34380724 | Derived | 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. |
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| Reference testing |
| Diagnostic Test |
Culture-based testing |
|
| 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 |