NCT05175196

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.

Trial Health

53
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial recruitment is currently suspended
Enrollment
210

participants targeted

Target at P75+ for not_applicable

Timeline
10mo left

Started Jan 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress80%
Jan 2023Mar 2027

First Submitted

Initial submission to the registry

December 14, 2021

Completed
20 days until next milestone

First Posted

Study publicly available on registry

January 3, 2022

Completed
1 year until next milestone

Study Start

First participant enrolled

January 10, 2023

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

4.1 years

First QC Date

December 14, 2021

Last Update Submit

April 7, 2026

Conditions

Group A Streptococcal Infection

Keywords

saliva collectiondiagnosispediatric

Outcome Measures

Primary Outcomes (1)

  • Number of test results positive for GAS

    The primary aim of this study is to assess the efficacy of the CandyCollect platform to capture and detect Group A Streptococcus (GAS) in a small scale clinical study. The investigators will compare results of the CandyCollect sampling and a lollipop swab test to the rapid antigen detection test (RADT).

    day 1 (up to 40 minutes)

Secondary Outcomes (8)

  • Caregiver Experience Score (Bad/Good)

    day 1 (up to 40 minutes)

  • Caregiver Experience Score (Pleasant/Unpleasant)

    day 1 (up to 40 minutes)

  • Caregiver Sample Collection Preference

    day 1 (up to 40 minutes)

  • Number of Caregivers Willing to Have Their Child Perform the CandyCollect at Home

    day 1 (up to 40 minutes)

  • Pediatric Participant Wong-Baker FACES Pain Score for Each Sample Collection Method

    day 1 (up to 40 minutes)

  • +3 more secondary outcomes

Study Arms (1)

Pediatric Participants with GAS

EXPERIMENTAL

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").

Diagnostic Test: CandyCollectDiagnostic Test: Lollipop Swab

Interventions

CandyCollectDIAGNOSTIC_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.

Pediatric Participants with GAS
Lollipop SwabDIAGNOSTIC_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.

Pediatric Participants with GAS

Eligibility Criteria

Age5 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • Unable to suck on a swab or CandyCollect
  • Previous participation in this study
  • Self-reported sensitivity to sugar-free products
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Wisconsin Hospital and Clinics

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Conditions

Streptococcal InfectionsDisease

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Gregory DeMuri, MD

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 14, 2021

First Posted

January 3, 2022

Study Start

January 10, 2023

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2027

Last Updated

April 13, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)