Clinical trial NCT05175196: CandyCollect Strep Throat Testing
Official title: Microengineered Lollipop for Patient-Centric Saliva Collection
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Group A Streptococcal Infection
Keywords: saliva collection
diagnosis
pediatric
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2022-01-03
Enrollment: 210
Sex: ALL
Minimum age (years): 5
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Number of test results positive for GAS
timeFrame: day 1 (up to 40 minutes)
Secondary outcomes:
measure: Caregiver Experience Score (Bad/Good)
timeFrame: day 1 (up to 40 minutes)
measure: Caregiver Experience Score (Pleasant/Unpleasant)
timeFrame: day 1 (up to 40 minutes)
measure: Caregiver Sample Collection Preference
timeFrame: day 1 (up to 40 minutes)
measure: Number of Caregivers Willing to Have Their Child Perform the CandyCollect at Home
timeFrame: day 1 (up to 40 minutes)
measure: Pediatric Participant Wong-Baker FACES Pain Score for Each Sample Collection Method
timeFrame: day 1 (up to 40 minutes)
measure: Pediatric Participant Yummy / Yucky Score for Each Sample Collection Method
timeFrame: day 1 (up to 40 minutes)
measure: Pediatric Participant Sample Collection Preference
timeFrame: day 1 (up to 40 minutes)
measure: Number of Pediatric Participants Willing to do the CandyCollect at Home
timeFrame: day 1 (up to 40 minutes)
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin Hospital and Clinics
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Gregory DeMuri, MD
role: PRINCIPAL_INVESTIGATOR
References: