Rapid POC GAS Diagnostics in the Paediatric ED

Streptococcal Pharyngitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04247243
• Other study ID #: HAHSO POC GAS
• Status: Recruiting
• Phase: N/A
• Start date: January 4, 2021
• Est. completion date: May 1, 2024

Study information

• Verified date: March 2024
• Source: Hamilton Health Sciences Corporation
• Contact: Jeffrey Pernica, MD
• Phone: 9055212100
• Email: pernica[@]mcmaster.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 352
• Est. completion date: May 1, 2024
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Pharyngitis
• Streptococcal Pharyngitis

Intervention

Device:
• Rapid testing
Abbott ID NOW Strep A testing

Diagnostic Test:
• Reference testing
Culture-based testing

Locations

Country	Name	City	State
Canada	McMaster Children's Hospital	Hamilton	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Hamilton Health Sciences Corporation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Time to resolution of symptoms		3-5 and 7-10 days post-enrolment
Secondary	Caregiver satisfaction with testing	Likert scale	3-5 days post-enrolment
Secondary	Number of days of missed school/daycare		3-5 and 7-10 days post-enrolment
Secondary	Number of days of missed work (caregiver)		3-5 and 7-10 days post-enrolment
Secondary	Number of healthcare visits for pharyngitis or sinopulmonary infections		7 days post-enrolment
Secondary	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
Secondary	Number of household contacts subsequently diagnosed with GAS pharyngitis		7-10 days post-enrolment
Secondary	Proportion of point-of-care GAS tests that are uninterpretable		at enrolment
Secondary	Time required to utilize point-of-care testing	Time from consent to discharge from the ED	at enrolment