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Diagnostic Test
Lollipop Swab for Strep Throat
N/A
Recruiting
Led By Gregory DeMuri, MD
Research Sponsored by University of Wisconsin, Madison
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 (up to 40 minutes)
Awards & highlights
No Placebo-Only Group
Summary
This trial will test a new platform for detecting Group A Streptococcus in children ages 5-17. The platform, called LolliTest, will be compared to the current gold-standard test.
Who is the study for?
This trial is for children aged 5-17 with a sore throat caused by Group A Streptococcus (GAS), confirmed by a rapid test at the clinic. They must be able to understand and complete surveys in English, as should their parents or guardians who consent on their behalf. Children sensitive to sugar-free products or unable to use the CandyCollect swab are excluded.
What is being tested?
The study tests the CandyCollect platform's ability to detect GAS from a lollipop-like swab compared to standard rapid antigen testing. It aims to prove that this new, kid-friendly method is just as accurate for diagnosing strep throat during a single clinic visit.
What are the potential side effects?
Since the intervention involves using a non-invasive candy-like swab, side effects may include discomfort from sucking on the swab and potential issues for those with sensitivity to sugar-free products.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 1 (up to 40 minutes)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 (up to 40 minutes)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of test results positive for GAS
Secondary study objectives
Caregiver Experience Score (Bad/Good)
Caregiver Experience Score (Pleasant/Unpleasant)
Caregiver Sample Collection Preference
+5 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Pediatric Participants with GASExperimental Treatment2 Interventions
Children age 5-17 years old diagnosed via standard Rapid Antigen Detection Test with acute pharyngitis caused by Group A Streptococcus (GAS), along with their parent or legal guardian (aka "caregiver").
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Who is running the clinical trial?
University of Wisconsin, MadisonLead Sponsor
1,228 Previous Clinical Trials
3,198,398 Total Patients Enrolled
1 Trials studying Strep Throat
33 Patients Enrolled for Strep Throat
National Institutes of Health (NIH)NIH
2,811 Previous Clinical Trials
8,161,118 Total Patients Enrolled
Gregory DeMuri, MDPrincipal InvestigatorUniversity of Wisconsin, Madison
1 Previous Clinical Trials
180 Total Patients Enrolled
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