NCT03584737|TerminatedFDA Device
Study Stopped
Lack of funding
Point-of-Care Immunoassay for Detection of Bacterial Sinusitis
Multi-Center Study of a Point-of-Care Immunoassay for the Detection of Bacterial Sinusitis
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Sponsor study identifier
observational
800
1 country
7
Study Start
November 12, 2021
Actual (reported)Primary Completion
April 9, 2023
Actual (reported)Study Completion
April 10, 2023
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 10, 2023
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 19, 2018
Actual (reported)July 12, 2018
Actual (reported)November 12, 2021
Actual (reported)April 9, 2023
Actual (reported)April 10, 2023
Actual (reported)Sensitivity (positive predictive agreement) and specificity (negative predictive agreement) of the diagnostic device
Assessment of the true positive and true negative rate of the point-of-care test device relative to the composite reference standard for each of the 3 bacterial microorganisms.
Cumulation of one-time subject sample results obtained in 20-30 minutes for point-of-care test and 3-5 days for lab results
Positive predictive value (PPV) and negative predictive value (NPV)
Cumulation of one-time subject sample results obtained in 20-30 minutes for point-of-care test and 3-5 days for lab results
Positive likelihood ratio (LR+) and negative likelihood ratio (LR-)
Cumulation of one-time subject sample results obtained in 20-30 minutes for point-of-care test and 3-5 days for lab results
Samples from participants showing symptoms of bacterial sinusitis tested by rapid in vitro diagnostic test, bacterial culture, and PCR assay
IVD for qualitative detection of 3 bacterial pathogens (Haemophilus influenzae, Moraxella catarrhalis, and Streptococcus pneumoniae)
Quantitative bacterial culture assay with isolate identification by MALDI-TOF.
Patients at least 18 years of age with symptoms of bacterial sinusitis from primary care clinics and otolaryngology clinics.
Northern California Research
Sacramento, California, 95821, United States
Hillcrest Medical Research
DeLand, Florida, 32720, United States
ENT Allergy & Associates of South Florida
Port Saint Lucie, Florida, 34952, United States
Tandem Clinical Research
Marrero, Louisiana, 70072, United States
Northwell Health
New Hyde Park, New York, 11042, United States
Optimed Research/Ohio Sinus Institute
Dublin, Ohio, 43016, United States
Kelsey-Seybold Clinic
Houston, Texas, 77025, United States
nasal mucus in buffer solution
Karen Busch
Beaufort
800 participants (actual enrollment reported by the registry).
First Submitted
June 19, 2018
First Posted
July 12, 2018
Study Start
November 12, 2021
Actual (reported)Semiquantitative real-time PCR assay
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
April 9, 2023
Actual (reported)Study Completion
April 10, 2023
Actual (reported)Last Updated
April 12, 2023
Record last verified: 2023-04
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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