Testing a new saliva collection method for strep throat in children
Microengineered Lollipop for Patient-Centric Saliva Collection
This study is testing a new way to collect saliva samples from kids with strep throat to see if it works as well as the usual tests.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 210 (estimated) |
| Ages | 5 Years to 17 Years |
| Sex | All |
| Sponsor | University of Wisconsin, Madison Academic / other |
| Locations | 1 site (Madison, Wisconsin) |
| Trial ID | NCT05175196 on ClinicalTrials.gov |
What this trial studies
This study enrolls children aged 5-17 who test positive for Group A Streptococcus (GAS) to evaluate the accuracy and feasibility of the CandyCollect platform for saliva sample collection. The study aims to demonstrate that this new method is as effective as traditional rapid antigen detection tests for diagnosing GAS. Participants will provide saliva samples and complete surveys during their clinic visit, which will help refine the device's design. The long-term goal is to establish saliva sampling as a preferred and less invasive diagnostic method for respiratory diseases.
Who should consider this trial
Good fit: Ideal candidates are children aged 5-17 who have been diagnosed with acute pharyngitis caused by Group A Streptococcus.
Not a fit: Patients who are unable to suck on a swab or have a sensitivity to sugar-free products may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to a more comfortable and effective method for diagnosing strep throat in children.
How similar studies have performed: While the approach of using saliva for diagnostics is innovative, similar studies have shown promise in improving sample collection methods for respiratory infections.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Unable to suck on a swab or CandyCollect * Previous participation in this study * Self-reported sensitivity to sugar-free products Inclusion for Caregiver Participants: * Parent or legal guardian able to provide consent for child participant * Physically present at the clinic with the child * Able consent and complete surveys in English Exclusion for Caregiver Participants: * Does not meet inclusion criteria
Where this trial is running
Madison, Wisconsin
- University of Wisconsin Hospital and Clinics — Madison, Wisconsin, United States (Recruiting)
Study contacts
- Principal investigator: Gregory DeMuri, MD — University of Wisconsin, Madison
- Study coordinator: Elena Alfaro
- Email: elalfaro@wisc.edu
- Phone: (608) 890-0584
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.