CandyCollect Strep Throat Testing

NCT ID: NCT05175196

Last Updated: 2025-10-23

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 210 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-10
• Study Completion Date: 2026-03-31

Brief 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.

Detailed Description

The rationale for this study is to demonstrate the potential of the CandyCollect platform for acquisition of samples from children in the clinic. With deliberate design to maximize collection performance from saliva sampling, the investigators long-term vision is that the CandyCollect platform will achieve better sensitivity and specificity than can be obtained with current biospecimen collection techniques, while providing a platform that is preferred by patients and usable in home settings. Ultimately, the CandyCollect has the potential to make saliva sampling a new gold standard for respiratory disease diagnostics and prevent the discomfort associated with a pharyngeal swab.

The Theberge Lab at the University of Washington that is developing CandyCollect is using data collected throughout the study to iterate the engineering of the device. As such, analyses were performed after Cohort 1 (n=30 dyad completers), and in line with the iterative nature of this study, the study team adjusted the study design to further inform the engineering of the device. For Cohort 2, which will also target n=30 dyad completers, the study team will still administer surveys to the child and caregiver and collect 4 saliva samples from each child. Cohort 3 will target n= 30 dyad completers, and the study team will administer surveys and collect 5 saliva samples from each child.

Intervention:

• Cohort 1: Pediatric participants diagnosed with GAS via rapid antigen detection test (RADT) will be asked to suck on a swab for 10 seconds, like sucking on a lollipop. They will then be asked to suck on a candy lollipop that will collect their saliva. Participants will do each type of saliva collection twice-two swabs, then two lollipops. Afterwards, participants (both pediatric and caregiver) will fill out a short survey asking about their feelings and opinions about the different types of tests.
• Cohort 2: Pediatric participants diagnosed with GAS via rapid antigen detection test (RADT) will be asked to suck on four CandyCollect devices and one lollipop swab. The CandyCollect devices will be designed such that one will take 10 seconds to obtain, one will take 30 seconds to obtain; and two will each take 1 minute to obtain; participants will be instructed to suck on the CandyCollect device for these durations. Afterwards, participants (both pediatric and caregiver) will fill out a short survey asking about their feelings and opinions about the different types of tests.
• Cohort 3: Pediatric participants diagnosed with GAS via rapid antigen detection test (RADT) children will use the first four CandyCollect devices for 1 minute and the fifth CandyCollect device until it dissolves (about 1.5 - 3.5 minutes). They will also use 1 lollipop swab. [Cohort 3 is not funded by NIH]

Specific aims:

• Aim 1: The primary aim of this study is to assess the efficacy of the CandyCollect platform to capture and detect GAS in a small scale clinical study. The investigators will compare results of the CandyCollect sampling with both the RADT, which is the current gold standard, as well as a lollipop swab.
• Aim 2: The secondary aim of this study is to evaluate the usability of the CandyCollect device by surveying pediatric participant and parent experience, acceptance of the collection technique, and their willingness to perform the test at home.

Hypotheses to be tested:

• Aim 1: The CandyCollect platform is non-inferior to gold-standard RADT for GAS.
• Aim 2: Pediatric participants and their parent/legal guardians will have a more positive experience with the CandyCollect than the RADT throat swab or the lollipop swab, and they will be willing to do the CandyCollect at home.

Conditions

Group A Streptococcal Infection

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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").

Group Type: EXPERIMENTAL

CandyCollect

Intervention Type: DIAGNOSTIC_TEST

The CandyCollect device is a novel, micro-engineered, lollipop-inspired platform. It has functionalized open microchannels for pathogen capture and concentration. It also has time-controlled flavoring release to make the platform more patient-centric.

Lollipop Swab

Intervention Type: DIAGNOSTIC_TEST

The "lollipop" swab is a typical swab that would be used to obtain routine pharyngeal samples. Child participants are instructed to suck on the swab for 10 seconds, as they would suck on a lollipop. Participant will be asked to take this test twice.

Interventions

CandyCollect

The CandyCollect device is a novel, micro-engineered, lollipop-inspired platform. It has functionalized open microchannels for pathogen capture and concentration. It also has time-controlled flavoring release to make the platform more patient-centric.

Intervention Type: DIAGNOSTIC_TEST

Lollipop Swab

The "lollipop" swab is a typical swab that would be used to obtain routine pharyngeal samples. Child participants are instructed to suck on the swab for 10 seconds, as they would suck on a lollipop. Participant will be asked to take this test twice.

Intervention Type: DIAGNOSTIC_TEST

Eligibility 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:

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role: collaborator

University of Wisconsin, Madison

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gregory DeMuri, MD

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

University of Wisconsin Hospital and Clinics

Madison, Wisconsin, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Elena Alfaro

Role: CONTACT

elalfaro@wisc.edu

(608) 890-0584

Other Identifiers

A536756

Identifier Type: OTHER

Identifier Source: secondary_id

Protocol Version 2/28/2025

Identifier Type: OTHER

Identifier Source: secondary_id

SMPH\PEDIATRICS\INFECT DIS

Identifier Type: OTHER

Identifier Source: secondary_id

R21AI166120

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2021-1427

Identifier Type: -

Identifier Source: org_study_id