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| ID | Type | Description | Link |
|---|---|---|---|
| A536756 | Other Identifier | UW Madison | |
| Protocol Version 2/28/2025 | Other Identifier | UW Madison | |
| SMPH\PEDIATRICS\INFECT DIS | Other Identifier | UW Madison | |
| R21AI166120 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
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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.
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:
Specific aims:
Hypotheses to be tested:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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"). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CandyCollect | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | day 1 (up to 40 minutes) |
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Inclusion Criteria:
Exclusion Criteria:
Inclusion for Caregiver Participants:
Exclusion for Caregiver Participants:
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| Name | Affiliation | Role |
|---|---|---|
| Gregory DeMuri, MD | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin Hospital and Clinics | Madison | Wisconsin | 53792 | United States |
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| ID | Term |
|---|---|
| D013290 | Streptococcal Infections |
| D004194 | Disease |
| ID | Term |
|---|---|
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| Lollipop Swab | 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. |
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| 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. | 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. | 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. | 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. | 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. | 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. | 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. | day 1 (up to 40 minutes) |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |