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Molecular Diagnostics

Rapid POC Diagnostics for Strep Throat

N/A

Recruiting

Research Sponsored by Hamilton Health Sciences Corporation

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at enrolment

Awards & highlights

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.

Who is the study for?

This trial is for children aged 3-18 who visit the McMaster Children's Hospital Emergency Department with a sore throat and need a GAS test. They can't have taken antibiotics effective against GAS in the last 72 hours.Check my eligibility

What is being tested?

The study compares rapid point-of-care molecular diagnostics for strep throat with standard culture-based tests to see which is more effective in diagnosing and managing the condition quickly.See study design

What are the potential side effects?

There are generally no side effects associated with these diagnostic tests, but there may be minor discomfort or gagging during the throat swab procedure.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3-5 and 7-10 days post-enrolment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3-5 and 7-10 days post-enrolment

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3-5 and 7-10 days post-enrolment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Appropriate antibiotic treatment

Secondary outcome measures

Caregiver satisfaction with testing

ED MD satisfaction with testing

Number of days of missed school/daycare

+6 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Rapid testingExperimental Treatment1 Intervention

Abbott ID NOW Strep A testing.

Group II: Reference testingActive Control1 Intervention

Culture-based testing.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Rapid testing

2012

N/A

~1000

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Hamilton Health Sciences CorporationLead Sponsor

368 Previous Clinical Trials

300,641 Total Patients Enrolled

Media Library

Rapid testing (Molecular Diagnostics) Clinical Trial Eligibility Overview. Trial Name: NCT04247243 — N/A

Strep Throat Research Study Groups: Reference testing, Rapid testing

Strep Throat Clinical Trial 2023: Rapid testing Highlights & Side Effects. Trial Name: NCT04247243 — N/A

Rapid testing (Molecular Diagnostics) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04247243 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

Recent research and studies

BMJ OpenJournal

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

Pernica, Jeffrey M, Fiona Smaill, April J Kam, Amy Bartholomew, Quynh Doan, Marek Smieja, Sarah Khan, Melani Sung, Lehana Thabane, and David M Goldfarb. 2021. “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. BMJ. doi:10.1136/bmjopen-2020-047271.

clinicaltrials.govStudy

Rapid POC GAS Diagnostics in the Paediatric ED

2021. "Rapid POC GAS Diagnostics in the Paediatric ED". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04247243.