Rapid testing for Strep Throat

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
McMaster Children's Hospital, Hamilton, CanadaStrep ThroatRapid testing - Device
Eligibility
3 - 18
All Sexes
What conditions do you have?
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Study Summary

This trial is testing how effective a rapid point-of-care molecular GAS diagnostics is compared to standard culture-based techniques for diagnosing children aged 3-18 years of age with a sore throat.

Eligible Conditions
  • Strep Throat

Treatment Effectiveness

Study Objectives

1 Primary · 9 Secondary · Reporting Duration: at enrolment

Day 10
Number of days of missed school/daycare
Number of days of missed work (caregiver)
Time to resolution of symptoms
3-5 days post-enrolment
Appropriate antibiotic treatment
Caregiver satisfaction with testing
7 days post-enrolment
Number of healthcare visits for pharyngitis or sinopulmonary infections
7-10 days post-enrolment
Number of household contacts subsequently diagnosed with GAS pharyngitis
At enrolment
ED MD satisfaction with testing
at enrolment
Proportion of point-of-care GAS tests that are uninterpretable
Time required to utilize point-of-care testing

Trial Safety

Trial Design

2 Treatment Groups

Reference testing
1 of 2
Rapid testing
1 of 2

Active Control

Experimental Treatment

352 Total Participants · 2 Treatment Groups

Primary Treatment: Rapid testing · No Placebo Group · N/A

Rapid testing
Device
Experimental Group · 1 Intervention: Rapid testing · Intervention Types: Device
Reference testing
DiagnosticTest
ActiveComparator Group · 1 Intervention: Reference testing · Intervention Types: DiagnosticTest
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rapid testing
2012
N/A
~1000

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: at enrolment

Who is running the clinical trial?

Hamilton Health Sciences CorporationLead Sponsor
347 Previous Clinical Trials
271,996 Total Patients Enrolled

Eligibility Criteria

Age 3 - 18 · All Participants · 1 Total Inclusion Criteria

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Frequently Asked Questions

Are there any openings for the public to take part in this trial at present?

"Affirmative - the information available on clinicaltrials.gov points to this study actively seeking participants. The trial was launched on April 1st 2021, and has recently been revised as of March 21 2022; 352 individuals are needed for enrolment at a single site." - Anonymous Online Contributor

Unverified Answer

Does the age of 25 serve as a cutoff for participants in this medical study?

"This trial is seeking participants aged 3 to 18, with 4 studies dedicated solely for those under the age of eighteen and 8 trials targeted toward patients over 65 years old." - Anonymous Online Contributor

Unverified Answer

How many individuals are currently taking part in this clinical investigation?

"Affirmative. According to data hosted on clinicaltrials.gov, this medical study – initially posted in April 2021 – is currently searching for participants. 352 test subjects need to be recruited from 1 trial site." - Anonymous Online Contributor

Unverified Answer

Is it feasible for me to register as a participant in this trial?

"This scientific study aims to recruit 352 minors aged 3 to 18 who exhibit symptoms of streptococcal pharyngitis. The primary entrance criterion is that individuals need a throat swab conducted for GAS testing." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.