NCT03584737

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
800

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2021

Geographic Reach
1 country

7 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 19, 2018

Completed
23 days until next milestone

First Posted

Study publicly available on registry

July 12, 2018

Completed
3.3 years until next milestone

Study Start

First participant enrolled

November 12, 2021

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 9, 2023

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 10, 2023

Completed
Last Updated

April 12, 2023

Status Verified

April 1, 2023

Enrollment Period

1.4 years

First QC Date

June 19, 2018

Last Update Submit

April 10, 2023

Conditions

Sinusitis Bacterial

Keywords

acute sinusitisbacterial sinusitispoint-of-carein vitro diagnostic device (IVD)

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • 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

Study Arms (1)

Symptomatic for bacterial sinusitis

Samples from participants showing symptoms of bacterial sinusitis tested by rapid in vitro diagnostic test, bacterial culture, and PCR assay

Diagnostic Test: rapid in vitro diagnostic testDiagnostic Test: bacterial cultureDiagnostic Test: PCR assay

Interventions

rapid in vitro diagnostic testDIAGNOSTIC_TEST

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

Also known as: Sinu-Test®
Symptomatic for bacterial sinusitis
bacterial cultureDIAGNOSTIC_TEST

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

Symptomatic for bacterial sinusitis
PCR assayDIAGNOSTIC_TEST

Semiquantitative real-time PCR assay

Symptomatic for bacterial sinusitis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients at least 18 years of age with symptoms of bacterial sinusitis from primary care clinics and otolaryngology clinics.

You may qualify if:

  • Meets definition of acute sinusitis by Infectious Disease Society of America (2012)

You may not qualify if:

  • Chronic sinusitis
  • Cystic fibrosis
  • Patients treated with antibiotics currently or within the previous 30 days.
  • Subjects with a prior history of sinus surgery will be excluded due to the modification of sinonasal anatomy.
  • Primary immunodeficiencies, as self-reported
  • Combined variable immunodeficiency
  • Immunodeficiency with reduced immunoglobulin G (IgG) and immunoglobulin A (IgA)-bearing cells
  • Kartagener Syndrome (ciliary dyskinesia)
  • Agammaglobulinemia
  • Sickle cell disease
  • Acquired immunodeficiencies, as self-reported
  • Chemotherapy
  • Radiation therapy
  • Transplantation
  • Asplenia
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Northern California Research

Sacramento, California, 95821, United States

Location

Hillcrest Medical Research

DeLand, Florida, 32720, United States

Location

ENT Allergy & Associates of South Florida

Port Saint Lucie, Florida, 34952, United States

Location

Tandem Clinical Research

Marrero, Louisiana, 70072, United States

Location

Northwell Health

New Hyde Park, New York, 11042, United States

Location

Optimed Research/Ohio Sinus Institute

Dublin, Ohio, 43016, United States

Location

Kelsey-Seybold Clinic

Houston, Texas, 77025, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

nasal mucus in buffer solution

Study Officials

  • Karen Busch

    Beaufort

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 19, 2018

First Posted

July 12, 2018

Study Start

November 12, 2021

Primary Completion

April 9, 2023

Study Completion

April 10, 2023

Last Updated

April 12, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

US(7)