MedTrace Logo

Point-of-Care Immunoassay for Detection of Bacterial Sinusitis

NCT03584737 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 800

Last updated 2023-04-12

No results posted yet for this study

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.

Conditions

  • Sinusitis Bacterial

Interventions

DIAGNOSTIC_TEST

rapid in vitro diagnostic test

IVD for qualitative detection of 3 bacterial pathogens (Haemophilus influenzae, Moraxella catarrhalis, and Streptococcus pneumoniae)

DIAGNOSTIC_TEST

bacterial culture

Quantitative bacterial culture assay with isolate identification by MALDI-TOF.

DIAGNOSTIC_TEST

PCR assay

Semiquantitative real-time PCR assay

Sponsors & Collaborators

  • Beaufort

    collaborator UNKNOWN

  • ENTvantage Dx

    lead INDUSTRY

Principal Investigators

  • Karen Busch · Beaufort

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-12
Primary Completion
2023-04-09
Completion
2023-04-10
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03584737 on ClinicalTrials.gov