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CandyCollect Strep Throat Testing

Primary Purpose

Group A Streptococcal Infection

Status
Suspended
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CandyCollect
Lollipop Swab
Sponsored by
University of Wisconsin, Madison
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Group A Streptococcal Infection focused on measuring saliva collection, diagnosis, pediatric

Eligibility Criteria

5 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Wisconsin Hospital and Clinics

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pediatric Participants with GAS

Arm Description

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").

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Caregiver Experience Score (Bad/Good)
The secondary aim of this study is to evaluate the usability of the CandyCollect device by surveying participant experience with the throat swab, lollipop swab, and CandyCollect. Caregivers will be asked to rate their experiences on a scale of -5 (bad) to 5 (good). Mean scores for each feeling for each test will be reported.
Caregiver Experience Score (Pleasant/Unpleasant)
The secondary aim of this study is to evaluate the usability of the CandyCollect device by surveying participant experience with the throat swab, lollipop swab, and CandyCollect. Caregivers will be asked to rate their experiences on a scale of 1 (pleasant) to 7 (unpleasant). Mean scores for each feeling for each test will be reported.
Caregiver Sample Collection Preference
The acceptance of the CandyCollect device relative to other sample collection methods will be measured by surveying preferred sample collection method for their child if they needed another test next week, which method they preferred, which method was most suitable for children in general, and which method was least invasive. Count of Caregivers for each question for each sample collection method will be reported.
Number of Caregivers Willing to Have Their Child Perform the CandyCollect at Home
Acceptability of the CandyCollect device will be in part measured by Caregiver willingness to perform the test at home.
Pediatric Participant Wong-Baker FACES Pain Score for Each Sample Collection Method
Pediatric participants will be surveyed with the Wong-Baker FACES Pain Rating Scale for their experience with the throat swab, lollipop swab, and CandyCollect. Scores range from 1-10, where higher scores indicate increased pain.
Pediatric Participant Sample Collection Preference
Pediatric participants will be asked with sample collection method they prefer: throat swab, lollipop swab, or CandyCollect.
Number of Pediatric Participants Willing to do the CandyCollect at Home
Acceptability of the intervention will be in part measured by asking pediatric participants if they are willing to do the CandyCollect at home.

Full Information

First Posted
December 14, 2021
Last Updated
September 11, 2023
Sponsor
University of Wisconsin, Madison
Collaborators
National Institutes of Health (NIH)
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1. Study Identification

Unique Protocol Identification Number
NCT05175196
Brief Title
CandyCollect Strep Throat Testing
Official Title
Microengineered Lollipop for Patient-Centric Saliva Collection
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Suspended
Why Stopped
interim analysis
Study Start Date
January 10, 2023 (Actual)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison
Collaborators
National Institutes of Health (NIH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes

5. Study Description

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 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. Intervention: 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Group A Streptococcal Infection
Keywords
saliva collection, diagnosis, pediatric

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pediatric Participants with GAS
Arm Type
Experimental
Arm Description
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").
Intervention Type
Diagnostic Test
Intervention Name(s)
CandyCollect
Intervention Description
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. Participant will be asked to take this test twice.
Intervention Type
Diagnostic Test
Intervention Name(s)
Lollipop Swab
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of test results positive for GAS
Description
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).
Time Frame
day 1 (up to 40 minutes)
Secondary Outcome Measure Information:
Title
Caregiver Experience Score (Bad/Good)
Description
The secondary aim of this study is to evaluate the usability of the CandyCollect device by surveying participant experience with the throat swab, lollipop swab, and CandyCollect. Caregivers will be asked to rate their experiences on a scale of -5 (bad) to 5 (good). Mean scores for each feeling for each test will be reported.
Time Frame
day 1 (up to 40 minutes)
Title
Caregiver Experience Score (Pleasant/Unpleasant)
Description
The secondary aim of this study is to evaluate the usability of the CandyCollect device by surveying participant experience with the throat swab, lollipop swab, and CandyCollect. Caregivers will be asked to rate their experiences on a scale of 1 (pleasant) to 7 (unpleasant). Mean scores for each feeling for each test will be reported.
Time Frame
day 1 (up to 40 minutes)
Title
Caregiver Sample Collection Preference
Description
The acceptance of the CandyCollect device relative to other sample collection methods will be measured by surveying preferred sample collection method for their child if they needed another test next week, which method they preferred, which method was most suitable for children in general, and which method was least invasive. Count of Caregivers for each question for each sample collection method will be reported.
Time Frame
day 1 (up to 40 minutes)
Title
Number of Caregivers Willing to Have Their Child Perform the CandyCollect at Home
Description
Acceptability of the CandyCollect device will be in part measured by Caregiver willingness to perform the test at home.
Time Frame
day 1 (up to 40 minutes)
Title
Pediatric Participant Wong-Baker FACES Pain Score for Each Sample Collection Method
Description
Pediatric participants will be surveyed with the Wong-Baker FACES Pain Rating Scale for their experience with the throat swab, lollipop swab, and CandyCollect. Scores range from 1-10, where higher scores indicate increased pain.
Time Frame
day 1 (up to 40 minutes)
Title
Pediatric Participant Sample Collection Preference
Description
Pediatric participants will be asked with sample collection method they prefer: throat swab, lollipop swab, or CandyCollect.
Time Frame
day 1 (up to 40 minutes)
Title
Number of Pediatric Participants Willing to do the CandyCollect at Home
Description
Acceptability of the intervention will be in part measured by asking pediatric participants if they are willing to do the CandyCollect at home.
Time Frame
day 1 (up to 40 minutes)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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: Does not meet inclusion criteria
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gregory DeMuri, MD
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Wisconsin Hospital and Clinics
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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CandyCollect Strep Throat Testing

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