Group A Streptococcal InfectionNCT03777098
Pilot Study of Strepic® Device for the Diagnosis of Group A Streptococcal Pharyngitis
An observational study of Group A Streptococcal Infection, run by David A. Talan at 1 site in United States.
Trial summary
The objective of this pilot study is to acquire images using the Strepic® device, a clinical prototype that has been designed specifically as a viable, low-cost, commercially realizable autofluorescence-based diagnostic test, using (1) fluorescence and (2) white light image data, as well as other clinical data points. Read more about this study
- Who is it for?
- Ages 7 to 64 years
- Conditions the study is for
- Group A Streptococcal Infection
- What is being tested?
- Strepic® Device
- Type of treatment
- Medical device
- How many people
- 426 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jan 2019to 30 Dec 2021
- 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 7 to 64 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients presenting to participating U.S. emergency departments or clinics with complaint of pharyngitis will be screened.
Who may be able to join
- All patients aged 7-64 years of age with suspected GAS pharyngitis with modified Centor (McIsaac) score ≥2; and
- Patient agrees to participate in study and patient or parent/guardian sign consent/assent form.
Who cannot join
- Pharyngeal swab performed immediately prior to study team approach;
- Prior enrollment in this study;
- Pharyngeal symptoms >7 days;
- Peritonsillar abscess;
- Antibiotic use within one week of index visit;
- Inability to open mouth to visualize the pharynx; and
Show all 9Show fewer
- Inability to understand English or Spanish, as study forms including consent and assent forms will be written in English and Spanish;
- Woman who is pregnant (self-reported, pregnancy test will not be performed) or nursing;
- Current prisoner (define as an individual involuntarily confined in a penal institution, including persons: (1) sentenced under a criminal or civil statue; (2) detained pending arraignment, trial, or sentencing; and (3) detained in other facilities (e.g., for drug detoxification or treatment of alcoholism) under statutes or commitment procedures providing such alternatives to criminal prosecution or incarceration in a penal institution).
Trial locations and contacts
1 site in 1 country.
United States1 site
Olive View-UCLA Medical Center
Sylmar, California, 91342
About this study
The objective of this pilot study is to acquire images using the Strepic® device, a clinical prototype that has been designed specifically as a viable, low-cost, commercially realizable autofluorescence-based diagnostic test, using (1) fluorescence and (2) white light image data, as well as other clinical data points. By acquiring and analyzing the images of pharyngeal bacterial fluorescence and white light patterns in patients with Group A Streptococcus (GAS)-associated pharyngitis and comparing them with those observed in non-GAS pharyngitis, it is believed an algorithm can be developed such that the device will improve the ability of clinicians to quickly and accurately identify GAS infections.
- Conditions
- Group A Streptococcal Infection
- Being tested
- Strepic® Device
- Medical subject headings
- Streptococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strepic® DeviceDevice
The Strepic® device is a qualitative point-of-care diagnostic test for the detection of GAS pharyngitis. The test uses direct visualization of the pharynx with a light source of specified wavelengths, causing excitation of endogenous fluorophores that emit a characteristic colored light pattern. White light images may give additional diagnostic accuracy through use of an artificial intelligence analysis of a large set of images of GAS and non-GAS pharyngitis.
What is being measured
The primary outcome is the main question the study is designed to answer.
Strepic Device Image
A picture of the participant's throat will be obtained at enrollment.
Measured: Day 1
Throat culture or PCR result
The results of throat culture or PCR (depending on the site) will be recorded and compared to the Strepic Device image findings
Measured: Day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2018
- Study start2 Jan 2019
- Primary completion30 Nov 2021
- Study completion30 Dec 2021
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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 426 participants (actual)
Sponsor and investigators
- Lead sponsor
- David A. Talan
- Sponsor type
- University, hospital or other
- Collaborators
- Light AI Inc.
- Responsible party
- Sponsor-investigator, David A. Talan, Olive View-UCLA Education & Research Institute
- Investigators
- Gregory Moran, MD, Principal investigator, Olive View-UCLA Education & Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03777098
- Sponsor's protocol ID
- 01-2018
- Status last verified
- Apr 2022
- First submitted
- 11 Dec 2018
- Last updated
- 20 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Strepic® Device for the Diagnosis of Group A Streptococcal Pharyngitis
- ClinicalTrials.gov ID
- NCT03777098
- Acronym / sponsor ID
- 01-2018
- Conditions
- Group A Streptococcal Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 426 participants (actual)
- Lead sponsor
- David A. TalanUniversity, hospital or other
- Collaborators
- Light AI Inc.
- Study start
- 2 Jan 2019 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 30 Dec 2021 (actual)
- First posted
- 17 Dec 2018 (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.
The objective of this pilot study is to acquire images using the Strepic® device, a clinical prototype that has been designed specifically as a viable, low-cost, commercially realizable autofluorescence-based diagnostic test, using (1) fluorescence and (2) white light image data, as well as other clinical data points. By acquiring and analyzing the images of pharyngeal bacterial fluorescence and white light patterns in patients with Group A Streptococcus (GAS)-associated pharyngitis and comparing them with those observed in non-GAS pharyngitis, it is believed an algorithm can be developed such that the device will improve the ability of clinicians to quickly and accurately identify GAS infections.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 7 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients presenting to participating U.S. emergency departments or clinics with complaint of pharyngitis will be screened.
Key inclusion criteria (2 listed)
- All patients aged 7-64 years of age with suspected GAS pharyngitis with modified Centor (McIsaac) score ≥2; and
- Patient agrees to participate in study and patient or parent/guardian sign consent/assent form.
Key exclusion criteria (9 listed)
- Pharyngeal swab performed immediately prior to study team approach;
- Prior enrollment in this study;
- Pharyngeal symptoms >7 days;
- Peritonsillar abscess;
- Antibiotic use within one week of index visit;
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 |
|---|---|---|
| Strepic® DeviceThe Strepic® device is a qualitative point-of-care diagnostic test for the detection of GAS pharyngitis. The test uses direct visualization of the pharynx with a light source of specified wavelengths, causing excitation of endogenous fluorophores that emit a characteristic colored light pattern. White light images may give additional diagnostic accuracy through use of an artificial intelligence analysis of a large set of images of GAS and non-GAS pharyngitis. | Device | – |
Primary outcome
Strepic Device Image
Time frame: Day 1
A picture of the participant's throat will be obtained at enrollment.
Throat culture or PCR result
Time frame: Day 2
The results of throat culture or PCR (depending on the site) will be recorded and compared to the Strepic Device image findings
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2022.
- Individual participant dataSharing planned: No
Related trials for Group A Streptococcal Infection
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
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
RecruitingPhase 3
Lot-to-lot Consistency Study of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants From 2 Months of Age
Pneumococcal Immunization, Healthy Volunteers
Not yet recruitingPhase 4
Short Versus Standard Amoxicillin for Pediatric Strep Throat
Group A Streptococcal (GAS) 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.
Gregory Moran, MD principal investigator
Olive View-UCLA Education & Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Group A Streptococcal Infection, run by David A. Talan 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 2 inclusion and 9 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: finished, as of the sponsor's last update on 20 Apr 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Strepic Device Image (time frame: Day 1). The study lists 2 primary outcomes in all. 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 20 Apr 2022.