Strept ThroatNCT04256694
Rapid Strep Test Results
An observational study of Strept Throat, run by Kendall Healthcare Group, Ltd. at 1 site in United States.
Trial summary
This is a prospective study seeks to determine how often a rapid antigens test for group A streptococcus is positive in healthy adults Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Strept Throat
- What is being tested?
- Rapid Antigen Test for Group A Streptococcus
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Feb 2020to 30 Apr 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy volunteers, primarily from subjects known to the investigators.
Who may be able to join
- Any person at least 18 years old
Who cannot join
- pregnant
- prisoners
- currently taking antibiotics
- any acute symptoms
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Kendall Regional Medical Center
Miami, Florida, 33175
Tony Zitek, MD, 305-480-6602, zitek10@gmail.com
About this study
Official title: Rapid Antigen Test Results for Group A Streptococcus in Healthy Adults
This is a prospective study seeks to determine how often a rapid antigens test for group A streptococcus is positive in healthy adults
Read the detailed description
The Unites States recommends the use of rapid antigen tests, but a number of other countries do not, citing a high prevalence of streptococcal carriers and only moderate sensitivity of rapid antigen tests [1]. Indeed, to fully understand when rapid antigen tests should be used, we need to know the streptococcal carrier rate for adults in the United States. Although there is a fair amount of data in this regard for children [2,3], the only study to report this value for adults was from over 20 years ago and was from Sweden [4]. That studied reported a Group A Streptococcus (GAS) carrier rate of 2.4-3.7% in healthy adults.
Given how many patients seek medical care for sore throats that may potentially be streptococcal pharyngitis, the investigators believe more data about the GAS carrier rate and the rate of false positive rapid antigen tests is necessary. Thus, the investigators propose a prospective study to evaluate the rate of positive rapid antigen tests in healthy adult patients in our community.
The investigators will perform rapid antigen tests for GAS on healthy adult subjects without any symptoms. Consenting patients will fill out a brief data collection form about their medical history, and an investigator will perform a rapid antigen throat swab to assess for GAS. The results of the rapid antigen test will be recorded, and a logistic regression analysis will be performed to determine if certain factors within the subject's medical history are predictive of positive rapid strep tests.
- Conditions
- Strept Throat
- Being tested
- Rapid Antigen Test for Group A Streptococcus
- Keywords
- Carrier rate, Rapid antigen test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rapid Antigen Test for Group A StreptococcusDiagnostic test
Rapid strep tests will be performed by throat swab of healthy adult volunteers.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Adult Subjects | Not described Receives: Diagnostic Test: Rapid Antigen Test for Group A Streptococcus |
What is being measured
The primary outcome is the main question the study is designed to answer.
% Positive Rapid Antigen Strep Tests
% of positive rapid antigen strep tests amongst all volunteers
Measured: The throat will be swabbed, and the swab will be immediately analyzed. The results are available after five minutes.
Secondary outcomes (1)
Predictors of Positive Strep Tests
Logistic regression analysis will assess if any of the following are significant predictors of positive strep tests: age, gender, race/ethnicity, chronic medical problems, whether or not the patient has had antibiotics within last month, whether or not they have a history of strep throat, and whether or not they are a medical student or healthcare professional.
Measured: After enrollment of all subjects, a logistic regression analysis will be performed.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start5 Feb 2020
- Primary completion30 Apr 2021 (estimated)
- Study completion30 Apr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Strept 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kendall Healthcare Group, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Florida International University
- Responsible party
- Sponsor
- Investigators
- Tony Zitek, MD, Principal investigator, Kendall Healthcare Group, Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04256694
- Sponsor's protocol ID
- 108360
- Status last verified
- Sep 2020
- First submitted
- 3 Feb 2020
- Last updated
- 3 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Matthys J, De Meyere M, van Driel ML, De Sutter A. Differences among international pharyngitis guidelines: not just academic. Ann Fam Med. 2007 Sep-Oct;5(5):436-43. doi: 10.1370/afm.741.
PubMed 17893386Shaikh N, Leonard E, Martin JM. Prevalence of streptococcal pharyngitis and streptococcal carriage in children: a meta-analysis. Pediatrics. 2010 Sep;126(3):e557-64. doi: 10.1542/peds.2009-2648. Epub 2010 Aug 9.
PubMed 20696723Oliver J, Malliya Wadu E, Pierse N, Moreland NJ, Williamson DA, Baker MG. Group A Streptococcus pharyngitis and pharyngeal carriage: A meta-analysis. PLoS Negl Trop Dis. 2018 Mar 19;12(3):e0006335. doi: 10.1371/journal.pntd.0006335. eCollection 2018 Mar.
PubMed 29554121Gunnarsson RK, Holm SE, Soderstrom M. The prevalence of beta-haemolytic streptococci in throat specimens from healthy children and adults. Implications for the clinical value of throat cultures. Scand J Prim Health Care. 1997 Sep;15(3):149-55. doi: 10.3109/02813439709018506.
PubMed 9323783
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rapid Antigen Test Results for Group A Streptococcus in Healthy Adults
- ClinicalTrials.gov ID
- NCT04256694
- Acronym / sponsor ID
- 108360
- Conditions
- Strept Throat
- Keywords
- Carrier rate, Rapid antigen test
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Kendall Healthcare Group, Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Florida International University
- Study start
- 5 Feb 2020 (actual)
- Primary completion
- 30 Apr 2021 (estimated)
- Study completion
- 30 Apr 2021 (estimated)
- First posted
- 5 Feb 2020 (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 is a prospective study seeks to determine how often a rapid antigens test for group A streptococcus is positive in healthy adults
Detailed description
The Unites States recommends the use of rapid antigen tests, but a number of other countries do not, citing a high prevalence of streptococcal carriers and only moderate sensitivity of rapid antigen tests [1]. Indeed, to fully understand when rapid antigen tests should be used, we need to know the streptococcal carrier rate for adults in the United States. Although there is a fair amount of data in this regard for children [2,3], the only study to report this value for adults was from over 20 years ago and was from Sweden [4]. That studied reported a Group A Streptococcus (GAS) carrier rate of 2.4-3.7% in healthy adults.
Given how many patients seek medical care for sore throats that may potentially be streptococcal pharyngitis, the investigators believe more data about the GAS carrier rate and the rate of false positive rapid antigen tests is necessary. Thus, the investigators propose a prospective study to evaluate the rate of positive rapid antigen tests in healthy adult patients in our community.
The investigators will perform rapid antigen tests for GAS on healthy adult subjects without any symptoms. Consenting patients will fill out a brief data collection form about their medical history, and an investigator will perform a rapid antigen throat swab to assess for GAS. The results of the rapid antigen test will be recorded, and a logistic regression analysis will be performed to determine if certain factors within the subject's medical history are predictive of positive rapid strep tests.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy Adult Subjects | – | Diagnostic Test: Rapid Antigen Test for Group A Streptococcus |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy volunteers, primarily from subjects known to the investigators.
Key inclusion criteria (1 listed)
- Any person at least 18 years old
Key exclusion criteria (4 listed)
- pregnant
- prisoners
- currently taking antibiotics
- any acute symptoms
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 |
|---|---|---|
| Rapid Antigen Test for Group A StreptococcusRapid strep tests will be performed by throat swab of healthy adult volunteers. | Diagnostic test | Healthy Adult Subjects |
Primary outcome
% Positive Rapid Antigen Strep Tests
Time frame: The throat will be swabbed, and the swab will be immediately analyzed. The results are available after five minutes.
% of positive rapid antigen strep tests amongst all volunteers
1 secondary outcome
Predictors of Positive Strep Tests
Time frame: After enrollment of all subjects, a logistic regression analysis will be performed.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2020.
- Background: PubMed 17893386Matthys J, De Meyere M, van Driel ML, De Sutter A. Differences among international pharyngitis guidelines: not just academic. Ann Fam Med. 2007 Sep-Oct;5(5):436-43. doi: 10.1370/afm.741.
- Background: PubMed 20696723Shaikh N, Leonard E, Martin JM. Prevalence of streptococcal pharyngitis and streptococcal carriage in children: a meta-analysis. Pediatrics. 2010 Sep;126(3):e557-64. doi: 10.1542/peds.2009-2648. Epub 2010 Aug 9.
- Background: PubMed 29554121Oliver J, Malliya Wadu E, Pierse N, Moreland NJ, Williamson DA, Baker MG. Group A Streptococcus pharyngitis and pharyngeal carriage: A meta-analysis. PLoS Negl Trop Dis. 2018 Mar 19;12(3):e0006335. doi: 10.1371/journal.pntd.0006335. eCollection 2018 Mar.
- Background: PubMed 9323783Gunnarsson RK, Holm SE, Soderstrom M. The prevalence of beta-haemolytic streptococci in throat specimens from healthy children and adults. Implications for the clinical value of throat cultures. Scand J Prim Health Care. 1997 Sep;15(3):149-55. doi: 10.3109/02813439709018506.
- Individual participant dataSharing planned: Undecided
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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.
Tony Zitek, MD principal investigator
Kendall Healthcare Group, Ltd.
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 Strept Throat, run by Kendall Healthcare Group, Ltd. 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 1 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: status not confirmed, as of the sponsor's last update on 3 Sep 2020. 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?
Contact Tony Zitek, MD (305-480-6602, zitek10@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
% Positive Rapid Antigen Strep Tests (time frame: The throat will be swabbed, and the swab will be immediately analyzed. The results are available after five minutes.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04256694, which also lists 4 linked publications.
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 3 Sep 2020.