Rapid Strep Test Results
Rapid Antigen Test Results for Group A Streptococcus in Healthy Adults
1 other identifier
observational
200
1 country
1
Brief Summary
This is a prospective study seeks to determine how often a rapid antigens test for group A streptococcus is positive in healthy adults
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 3, 2020
CompletedFirst Posted
Study publicly available on registry
February 5, 2020
CompletedStudy Start
First participant enrolled
February 5, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2021
CompletedSeptember 3, 2020
September 1, 2020
1.2 years
February 3, 2020
September 2, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
% Positive Rapid Antigen Strep Tests
% of positive rapid antigen strep tests amongst all volunteers
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
After enrollment of all subjects, a logistic regression analysis will be performed.
Study Arms (1)
Healthy Adult Subjects
Interventions
Rapid strep tests will be performed by throat swab of healthy adult volunteers.
Eligibility Criteria
Healthy volunteers, primarily from subjects known to the investigators.
You may qualify if:
- Any person at least 18 years old
You may not qualify if:
- pregnant
- prisoners
- currently taking antibiotics
- any acute symptoms
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Kendall Healthcare Group, Ltd.lead
- Florida International Universitycollaborator
Study Sites (1)
Kendall Regional Medical Center
Miami, Florida, 33175, United States
Related Publications (4)
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.
PMID: 17893386BACKGROUNDShaikh 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.
PMID: 20696723BACKGROUNDOliver 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.
PMID: 29554121BACKGROUNDGunnarsson 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.
PMID: 9323783BACKGROUND
Study Officials
- PRINCIPAL INVESTIGATOR
Tony Zitek, MD
Kendall Healthcare Group, Ltd.
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 3, 2020
First Posted
February 5, 2020
Study Start
February 5, 2020
Primary Completion
April 30, 2021
Study Completion
April 30, 2021
Last Updated
September 3, 2020
Record last verified: 2020-09