Microengineered Lollipop for Patient-Centric Saliva Collection
Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
This study will enroll children ages 5-17 who test positive for Group A Streptococcus (GAS) at a single clinic visit lasting approximately 30-60 minutes. The primary aim of this study is to assess the accuracy and feasibility of the CandyCollect platform to capture and detect GAS. The investigators hypothesize that the CandyCollect platform is non-inferior to gold-standard rapid antigen detection testing for GAS.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 5
Maximum Age: 17
Healthy Volunteers: f
View:
• Child age 5-17 years old
• Diagnosis of acute pharyngitis caused by GAS
• A positive RADT swab in clinic
• Able to assent and complete surveys in English
Locations
United States
Wisconsin
University of Wisconsin Hospital and Clinics
RECRUITING
Madison
Contact Information
Primary
Elena Alfaro
elalfaro@wisc.edu
(608) 890-0584
Time Frame
Start Date: 2023-01-10
Estimated Completion Date: 2025-09
Participants
Target number of participants: 210
Treatments
Experimental: Pediatric Participants with GAS
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).
Related Therapeutic Areas
Sponsors
Leads: University of Wisconsin, Madison
Collaborators: National Institutes of Health (NIH)