Back to resultsRapid POC GAS Diagnostics in the Paediatric ED
Primary Purpose
Streptococcal Pharyngitis
Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Rapid testing
Reference testing
Sponsored by
About this trial
This is an interventional diagnostic trial for Streptococcal Pharyngitis
Eligibility Criteria
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
Sites / Locations
- McMaster Children's HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Rapid testing
Reference testing
Arm Description
Abbott ID NOW Strep A testing.
Culture-based testing.
Outcomes
Primary Outcome Measures
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.'
Secondary Outcome Measures
Time to resolution of symptoms
Caregiver satisfaction with testing
Likert scale
Number of days of missed school/daycare
Number of days of missed work (caregiver)
Number of healthcare visits for pharyngitis or sinopulmonary infections
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.
Number of household contacts subsequently diagnosed with GAS pharyngitis
Proportion of point-of-care GAS tests that are uninterpretable
Time required to utilize point-of-care testing
Time from consent to discharge from the ED
Full Information
NCT ID
NCT04247243
First Posted
January 20, 2020
Last Updated
January 5, 2023
Sponsor
Hamilton Health Sciences Corporation
1. Study Identification
Unique Protocol Identification Number
NCT04247243
Brief Title
Rapid POC GAS Diagnostics in the Paediatric ED
Official Title
Streamlining Care Delivery in the Paediatric Emergency Department Using Rapid Point-of-care Diagnostics for Group A Streptococcus: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 4, 2021 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
February 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hamilton Health Sciences Corporation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Streptococcal Pharyngitis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
352 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Rapid testing
Arm Type
Experimental
Arm Description
Abbott ID NOW Strep A testing.
Arm Title
Reference testing
Arm Type
Active Comparator
Arm Description
Culture-based testing.
Intervention Type
Device
Intervention Name(s)
Rapid testing
Intervention Description
Abbott ID NOW Strep A testing
Intervention Type
Diagnostic Test
Intervention Name(s)
Reference testing
Intervention Description
Culture-based testing
Primary Outcome Measure Information:
Title
Appropriate antibiotic treatment
Description
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 Outcome Measure Information:
Title
Time to resolution of symptoms
Time Frame
3-5 and 7-10 days post-enrolment
Title
Caregiver satisfaction with testing
Description
Likert scale
Time Frame
3-5 days post-enrolment
Title
Number of days of missed school/daycare
Time Frame
3-5 and 7-10 days post-enrolment
Title
Number of days of missed work (caregiver)
Time Frame
3-5 and 7-10 days post-enrolment
Title
Number of healthcare visits for pharyngitis or sinopulmonary infections
Time Frame
7 days post-enrolment
Title
ED MD satisfaction with testing
Description
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
Title
Number of household contacts subsequently diagnosed with GAS pharyngitis
Time Frame
7-10 days post-enrolment
Title
Proportion of point-of-care GAS tests that are uninterpretable
Time Frame
at enrolment
Title
Time required to utilize point-of-care testing
Description
Time from consent to discharge from the ED
Time Frame
at enrolment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jeffrey Pernica, MD
Phone
9055212100
Ext
77577
Email
pernica@mcmaster.ca
Facility Information:
Facility Name
McMaster Children's Hospital
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8S 4K1
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeffrey Pernica, MD
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
34380724
Citation
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.
Results Reference
derived
Learn more about this trial
Rapid POC GAS Diagnostics in the Paediatric ED
We'll reach out to this number within 24 hrs