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Immunoassay

Symptomatic for bacterial sinusitis for Sinusitis

N/A
Waitlist Available
Research Sponsored by ENTvantage Dx
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* Meets definition of acute sinusitis by Infectious Disease Society of America (2012)
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one time subject sample result in 20-30 minutes for point-of-care test and 3-5 days for lab results
Awards & highlights

Summary

This study is conducted to evaluate the performance of a rapid, point-of-care in vitro diagnostic device (Sinu-Test®) for the qualitative detection of the three most common pathogens responsible for causing bacterial sinusitis.

Eligible Conditions
  • Sinusitis

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one time subject sample result in 20-30 minutes for point-of-care test and 3-5 days for lab results
This trial's timeline: 3 weeks for screening, Varies for treatment, and one time subject sample result in 20-30 minutes for point-of-care test and 3-5 days for lab results for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Sensitivity (positive predictive agreement) and specificity (negative predictive agreement) of the diagnostic device
Secondary outcome measures
Positive likelihood ratio (LR+) and negative likelihood ratio (LR-)
Positive predictive value (PPV) and negative predictive value (NPV)
Other outcome measures
Discordant results

Trial Design

1Treatment groups
Experimental Treatment
Group I: Symptomatic for bacterial sinusitisExperimental Treatment3 Interventions
Samples from participants showing symptoms of bacterial sinusitis tested by rapid in vitro diagnostic test, bacterial culture, and PCR assay

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Who is running the clinical trial?

ENTvantage DxLead Sponsor
BeaufortUNKNOWN
1 Previous Clinical Trials
81 Total Patients Enrolled
Jodi L Crutchleo, BSStudy DirectorBeaufort
~209 spots leftby Sep 2025
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