NCT03584737View on ClinicalTrials.gov

Point-of-Care Immunoassay for Detection of Bacterial Sinusitis

TerminatedOBSERVATIONAL
Enrollment

800

Participants

Timeline

Start Date

November 12, 2021

Primary Completion Date

April 9, 2023

Study Completion Date

April 10, 2023

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

Trial Locations (7)

11042

Northwell Health, New Hyde Park

32720

Hillcrest Medical Research, DeLand

34952

ENT Allergy & Associates of South Florida, Port Saint Lucie

43016

Optimed Research/Ohio Sinus Institute, Dublin

70072

Tandem Clinical Research, Marrero

77025

Kelsey-Seybold Clinic, Houston

95821

Northern California Research, Sacramento

Sponsors

Collaborators (1)

Beaufort
All Listed Sponsors
collaborator

Beaufort

UNKNOWN

lead

ENTvantage Dx

INDUSTRY

NCT03584737 - Point-of-Care Immunoassay for Detection of Bacterial Sinusitis | Biotech Hunter | Biotech Hunter