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Rapid Test for Strep Throat
Madison, WI
N/A
Recruiting
Led By Alexander Lepak, MD
Research Sponsored by University of Wisconsin, Madison
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Any age with immunocompromising conditions or is on immunocompromising medications with sore throat
Illness onset in the last 7 days
Must not have
Patient is already on an antiviral medication or an antibiotic medication
Anatomic anomalies that would prohibit safely collecting a pharyngeal swab specimen
Timeline
Screening 3 weeks
Treatment Varies
Follow Up emailed after spotfire testing, survey data collected from all participants through the end of the study (up to 4 months)
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to assess the effectiveness of a new rapid strep throat test called SPOTFIRE ST in urgent care settings. They will study how well the test works, how it can be helpful
See full description
Who is the study for?
This trial is for up to 200 individuals with sore throat symptoms, seeking treatment at urgent care. The study will take about 25 minutes of their time.Check my eligibility
What is being tested?
The SPOTFIRE ST System, a new point-of-care test for pharyngitis (sore throat), is being evaluated for its effectiveness and the satisfaction it provides to both healthcare providers and patients.See study design
What are the potential side effects?
Since this trial involves a diagnostic test rather than a medication or therapy, there are no direct side effects from the intervention itself.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a weak immune system and currently have a sore throat.
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My symptoms started within the last week.
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Select...
My child is between 1 and 2 years old and has a fever.
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Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am currently taking antiviral or antibiotic medication.
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Select...
I have a physical condition that makes it unsafe to collect throat swabs.
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Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ emailed after spotfire testing, survey data collected from all participants through the end of the study (up to 4 months)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~emailed after spotfire testing, survey data collected from all participants through the end of the study (up to 4 months)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Aim 2 Clinical Outcome: Number of Participants with follow up testing
Aim 2 Clinical Outcome: Summary of Resultant Prescriptions
Aim 2 Clinical Outcome: Summary of test results
+3 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Eligible SPOTFIRE ST ParticipantsExperimental Treatment1 Intervention
A maximum of 200 patients, representing the top 3-4 patient groups that were identified as benefitting most from a SPOTFIRE ST test through the provider survey, presenting at the Urgent Care facilities, will be enrolled.
Find a Location
Closest Location:UW Health Urgent Care Centers· Madison, WI
Who is running the clinical trial?
University of Wisconsin, MadisonLead Sponsor
1,246 Previous Clinical Trials
3,254,035 Total Patients Enrolled
BioMérieuxIndustry Sponsor
61 Previous Clinical Trials
43,326 Total Patients Enrolled
Alexander Lepak, MDPrincipal InvestigatorUW School of Medicine and Public Health