Strep ThroatNCT03907449
Preview Rapid Strep A Test Method Comparison Study
An observational study of Strep Throat, run by Guangzhou Wondfo Biotech Co., Ltd at 2 sites in United States.
Trial summary
This study is designed to determine the accuracy of the Preview Rapid Strep A Test compared to a laboratory reference method for Group A Streptococcal infection and to determine the precision of the Preview Rapid Strep A test. Read more about this study
- Who is it for?
- Ages 3 years and older
- Conditions the study is for
- Strep Throat
- What is being tested?
- Preview Rapid Strep A test
- How many people
- 320 participants
- Where
- 2 sitesUnited States
- Study dates
- 19 Mar 2019to May 2020
- Phase
- Observational
- 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 3 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Approximately 320 patients to be tested, expecting 50-100 positive for Strep A collected from patients of any age and gender from two CLIA waived or waivable sites. Children will be enrolled in this study due to the high prevalence of Strep A infections in minors and the intention to market this investigational device for use for all ages following FDA clearance.
Who may be able to join
- Any patient presenting with symptoms of pharyngitis
- Fever
- Sore throat
- Swollen lymph nodes in neck
- Redness of throat/tonsils
- White/yellow patches on tonsils
Show all 9Show fewer
- Not currently on antibiotics
- ≥3 years or older
- Ability to read, understand and sign a consent form, in English, or for parent(s) to sign an assent form providing permission to include children under the age of 18.
Who cannot join
- Currently taking antibiotics
- Previously enrolled in this study
Trial locations and contacts
2 sites in 1 country.
United States2 sites
UHSH Microbiology
Johnson City, New York, 13790
Summerwood Pediatrics
Liverpool, New York, 13088
About this study
This study is designed to determine the accuracy of the Preview Rapid Strep A Test compared to a laboratory reference method for Group A Streptococcal infection and to determine the precision of the Preview Rapid Strep A test.
- Conditions
- Strep Throat
- Being tested
- Preview Rapid Strep A test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preview Rapid Strep A testDiagnostic test
Rapid assay for the detection of type A streptococcal infection of the throat.
| Study group | Role | What they receive |
|---|---|---|
| Symptoms of Strep Throat | Any patient presenting with symptoms of pharyngitis
* Fever
* Sore throat
* Swollen lymph nodes in neck
* Redness of throat/tonsils
* White/yellow patches on tonsils
* Not currently on antibiotics Receives: Diagnostic Test: Preview Rapid Strep A test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of Preview Strep A Rapid Test
Determination of Positive Predictive Value and Negative Predictive Value for Preview Strep A
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2019
- Study start19 Mar 2019
- Primary completionMay 2020 (estimated)
- Study completionMay 2020 (estimated)
Why it stopped: Recruitment rates reduced during non-Strep season
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Strep ThroatStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou Wondfo Biotech Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Paul Granato, PhD, Principal investigator, UHSH MicrobiologyJagmohan Sidhu, MD, Principal investigator, UHSH Microbiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03907449
- Sponsor's protocol ID
- MDC_2018_Wondfo
- Status last verified
- Jul 2019
- First submitted
- 5 Apr 2019
- Last updated
- 9 Jul 2019
- Results posted
- No
- Data monitoring committee
- 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 9 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preview Rapid Strep A Test Method Comparison Study
- ClinicalTrials.gov ID
- NCT03907449
- Acronym / sponsor ID
- MDC_2018_Wondfo
- Conditions
- Strep Throat
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: Recruitment rates reduced during non-Strep season
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Guangzhou Wondfo Biotech Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 19 Mar 2019 (actual)
- Primary completion
- May 2020 (estimated)
- Study completion
- May 2020 (estimated)
- First posted
- 9 Apr 2019 (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 is designed to determine the accuracy of the Preview Rapid Strep A Test compared to a laboratory reference method for Group A Streptococcal infection and to determine the precision of the Preview Rapid Strep A test.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Symptoms of Strep Throat | – | Diagnostic Test: Preview Rapid Strep A testAny patient presenting with symptoms of pharyngitis * Fever * Sore throat * Swollen lymph nodes in neck * Redness of throat/tonsils * White/yellow patches on tonsils * Not currently on antibiotics |
Who may qualify
- Ages
- 3 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Approximately 320 patients to be tested, expecting 50-100 positive for Strep A collected from patients of any age and gender from two CLIA waived or waivable sites. Children will be enrolled in this study due to the high prevalence of Strep A infections in minors and the intention to market this investigational device for use for all ages following FDA clearance.
Key inclusion criteria (9 listed)
- Any patient presenting with symptoms of pharyngitis
- ≥3 years or older
- Ability to read, understand and sign a consent form, in English, or for parent(s) to sign an assent form providing permission to include children under the age of 18.
Key exclusion criteria (2 listed)
- Currently taking antibiotics
- Previously enrolled in this study
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 |
|---|---|---|
| Preview Rapid Strep A testRapid assay for the detection of type A streptococcal infection of the throat. | Diagnostic test | Symptoms of Strep Throat |
Primary outcome
Accuracy of Preview Strep A Rapid Test
Time frame: 3 months
Determination of Positive Predictive Value and Negative Predictive Value for Preview Strep A
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2019.
- Individual participant dataSharing planned: No
Related trials for Strep Throat
Not yet recruitingObservational study
A Multicenter Evaluation of SalivIQ™ Strep A for Detecting Group A Streptococcus From Saliva and Throat Swabs in Patients With Acute Pharyngitis
Streptococcal Pharyngitis, Group A Streptococcal Infection
Not yet recruitingPhase 1
Stopping Strep Throat With Antibodies in Healthy Adults.
Streptococcal Pharyngitis
Recruiting
Perspectives on Antibiotics and Tracking Symptoms in Children
Urinary Tract Infection, Cellulitis
Not yet recruitingPhase 4
Short Versus Standard Amoxicillin for Pediatric Strep Throat
Group A Streptococcal (GAS) Pharyngitis
RecruitingObservational study
GRoup A StrePtococcus
Streptococcal Pharyngitis
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.
Paul Granato, PhD principal investigator
UHSH Microbiology
Jagmohan Sidhu, MD principal investigator
UHSH Microbiology
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Strep Throat, run by Guangzhou Wondfo Biotech Co., Ltd at 2 sites 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 9 inclusion and 2 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 9 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Accuracy of Preview Strep A Rapid Test (time frame: 3 months). 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 9 Jul 2019.