Group A Streptococcal InfectionNCT05175196
CandyCollect Strep Throat Testing
A study testing CandyCollect and Lollipop Swab in people with Group A Streptococcal Infection, run by University of Wisconsin, Madison at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 17 years
- Conditions the study is for
- Group A Streptococcal Infection
- What is being tested?
- CandyCollect and Lollipop Swab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jan 2023to Mar 2027
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
- 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
Who cannot join
- Unable to suck on a swab or CandyCollect
- Previous participation in this study
- Self-reported sensitivity to sugar-free products
- Does not meet inclusion criteria
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53792
About this study
Official title: Microengineered Lollipop for Patient-Centric Saliva Collection
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.
Read the 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
- Being tested
- CandyCollect, Lollipop Swab
- Keywords
- saliva collection, diagnosis, pediatric
- Medical subject headings
- Streptococcal Infections, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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"). Receives: Diagnostic Test: CandyCollect; Diagnostic Test: Lollipop Swab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: day 1 (up to 40 minutes)
Secondary outcomes (8)
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.
Measured: day 1 (up to 40 minutes)
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.
Measured: day 1 (up to 40 minutes)
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.
Measured: day 1 (up to 40 minutes)
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.
Measured: day 1 (up to 40 minutes)
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.
Measured: day 1 (up to 40 minutes)
Pediatric Participant Yummy / Yucky Score for Each Sample Collection Method
Pediatric participants will be surveyed with Yummy to Yucky Scale for their experience with the throat swab, lollipop swab, and CandyCollect. Scores range from 1-5, where higher scores indicate worse experience.
Measured: day 1 (up to 40 minutes)
Pediatric Participant Sample Collection Preference
Pediatric participants will be asked with sample collection method they prefer: throat swab, lollipop swab, or CandyCollect.
Measured: day 1 (up to 40 minutes)
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.
Measured: day 1 (up to 40 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2022
- Study start10 Jan 2023
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Why it stopped: loss of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Group A Streptococcal InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gregory DeMuri, MD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05175196
- Sponsor's protocol ID
- 2021-1427
- Other IDs
- A536756, Protocol Version 2/28/2025, SMPH\PEDIATRICS\INFECT DIS, R21AI166120
- Status last verified
- Oct 2026
- First submitted
- 14 Dec 2021
- Last updated
- 23 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microengineered Lollipop for Patient-Centric Saliva Collection
- ClinicalTrials.gov ID
- NCT05175196
- Acronym / sponsor ID
- 2021-1427
- Conditions
- Group A Streptococcal Infection
- Keywords
- saliva collection, diagnosis, pediatric
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: loss of funding
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- 10 Jan 2023 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 3 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pediatric Participants with GAS | Experimental | Diagnostic Test: CandyCollect, Diagnostic Test: Lollipop SwabChildren 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"). |
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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
- Parent or legal guardian able to provide consent for child participant
Key exclusion criteria (4 listed)
- Unable to suck on a swab or CandyCollect
- Previous participation in this study
- Self-reported sensitivity to sugar-free products
- Does not meet inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CandyCollectThe 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. | Diagnostic test | Pediatric Participants with GAS |
| Lollipop SwabThe "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. | Diagnostic test | Pediatric Participants with GAS |
Primary outcome
Number of test results positive for GAS
Time frame: day 1 (up to 40 minutes)
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).
8 secondary outcomes
Caregiver Experience Score (Bad/Good)
Time frame: day 1 (up to 40 minutes)
Caregiver Experience Score (Pleasant/Unpleasant)
Time frame: day 1 (up to 40 minutes)
Caregiver Sample Collection Preference
Time frame: day 1 (up to 40 minutes)
Number of Caregivers Willing to Have Their Child Perform the CandyCollect at Home
Time frame: day 1 (up to 40 minutes)
Pediatric Participant Wong-Baker FACES Pain Score for Each Sample Collection Method
Time frame: day 1 (up to 40 minutes)
Pediatric Participant Yummy / Yucky Score for Each Sample Collection Method
Time frame: day 1 (up to 40 minutes)
Pediatric Participant Sample Collection Preference
Time frame: day 1 (up to 40 minutes)
Number of Pediatric Participants Willing to do the CandyCollect at Home
Time frame: day 1 (up to 40 minutes)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Group A Streptococcal Infection
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Lot-to-lot Consistency Study of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants From 2 Months of Age
Pneumococcal Immunization, Healthy Volunteers
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Short Versus Standard Amoxicillin for Pediatric Strep Throat
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gregory DeMuri, MD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CandyCollect and Lollipop Swab in people with Group A Streptococcal Infection, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of test results positive for GAS (time frame: day 1 (up to 40 minutes)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2026.