Rapid POC GAS Diagnostics in the Paediatric ED

Sponsor

Hamilton Health Sciences Corporation (Other)

Overall Status

Recruiting

CT.gov ID

NCT04247243

Collaborator

(none)

352

Enrollment

Location

Arms

36.9

Anticipated Duration (Months)

9.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Streptococcal Pharyngitis	Device: Rapid testing Diagnostic Test: Reference testing	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

352 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Jan 4, 2021

Anticipated Primary Completion Date :

Jan 1, 2024

Anticipated Study Completion Date :

Feb 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Rapid testing Abbott ID NOW Strep A testing.	Device: Rapid testing Abbott ID NOW Strep A testing
Active Comparator: Reference testing Culture-based testing.	Diagnostic Test: Reference testing Culture-based testing

Arm

Intervention/Treatment

Experimental: Rapid testing

Abbott ID NOW Strep A testing.

Device: Rapid testing

Abbott ID NOW Strep A testing

Active Comparator: Reference testing

Culture-based testing.

Diagnostic Test: Reference testing

Culture-based testing

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

Time to resolution of symptoms [3-5 and 7-10 days post-enrolment]
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]
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.
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

3 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	McMaster Children's Hospital	Hamilton	Ontario	Canada	L8S 4K1

Sponsors and Collaborators

Hamilton Health Sciences Corporation

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hamilton Health Sciences Corporation

ClinicalTrials.gov Identifier:

NCT04247243

Other Study ID Numbers:

HAHSO POC GAS

First Posted:

Jan 30, 2020

Last Update Posted:

Mar 22, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Yes

Additional relevant MeSH terms:

Pharyngitis

Study Results

No Results Posted as of Mar 22, 2022