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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03584737




Registration number
NCT03584737
Ethics application status
Date submitted
19/06/2018
Date registered
12/07/2018
Date last updated
25/04/2019

Titles & IDs
Public title
Point-of-Care Immunoassay for Detection of Bacterial Sinusitis
Scientific title
Multi-Center Study of a Point-of-Care Immunoassay for the Detection of Bacterial Sinusitis
Secondary ID [1] 0 0
1001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sinusitis Bacterial 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Diagnosis / Prognosis - rapid in vitro diagnostic test
Diagnosis / Prognosis - bacterial culture
Diagnosis / Prognosis - PCR assay

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

Healthy - no symptoms of sinusitis - Samples from healthy participants showing no symptoms of sinusitis tested by rapid in vitro diagnostic test, bacterial culture, and PCR assay


Diagnosis / Prognosis: rapid in vitro diagnostic test
IVD for qualitative detection of 3 bacterial pathogens (Haemophilus influenzae, Moraxella catarrhalis, and Streptococcus pneumoniae)

Diagnosis / Prognosis: bacterial culture
Quantitative bacterial culture assay with isolate identification by MALDI-TOF.

Diagnosis / Prognosis: PCR assay
Qualitative real-time PCR assay

Intervention code [1] 0 0
Diagnosis / Prognosis
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Sensitivity and specificity of the diagnostic device - Assessment of the true positive and true negative rate of the point-of-care test device relative to the lab culture reference standard for each of the 3 bacterial microorganisms.
Timepoint [1] 0 0
One time subject sample result in 20-30 minutes for point-of-care test and 3-5 days for lab results
Secondary outcome [1] 0 0
Positive predictive value (PPV) and negative predictive value (NPV) - Positive predictive value is the probability that subjects with a positive point-of-care test truly have the bacteria present. Negative predictive value is the probability that subjects with a negative point-of-care test truly do not have the bacteria present.
Timepoint [1] 0 0
One time subject sample result in 20-30 minutes for point-of-care test and 3-5 days for lab results

Eligibility
Key inclusion criteria
- Meets definition of acute sinusitis by Infectious Disease Society of America (2012)
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- 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

- HIV

- Poorly controlled Diabetes mellitus

- Cognitive impairment resulting in the inability to provide informed consent.

- Special groups, such as children under the age of 18, and men and women who are in
prison will not participate in this study.

Study design
Purpose
Duration
Cross-sectional
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,WA
Recruitment hospital [1] 0 0
Paratus Clinical Blacktown Clinic - Blacktown
Recruitment hospital [2] 0 0
Paratus Clinical Kanwal Clinic - Kanwal
Recruitment hospital [3] 0 0
Paratus Clinical Kippa Ring Clinic - Kippa-Ring
Recruitment hospital [4] 0 0
Captain Stirling Medical Centre - Nedlands
Recruitment postcode(s) [1] 0 0
2148 - Blacktown
Recruitment postcode(s) [2] 0 0
2259 - Kanwal
Recruitment postcode(s) [3] 0 0
4021 - Kippa-Ring
Recruitment postcode(s) [4] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Louisiana
Country [5] 0 0
United States of America
State/province [5] 0 0
New York
Country [6] 0 0
United States of America
State/province [6] 0 0
Ohio
Country [7] 0 0
United States of America
State/province [7] 0 0
Texas

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
ENTvantage Dx
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Beaufort
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Commercial sector/Industry
Name [2] 0 0
Clinical Network Services (CNS) Pty Ltd
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Entvantage Diagnostics Australia Pty Ltd
Address [3] 0 0
Country [3] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
This study is conducted to evaluate the performance of a rapid, point-of-care in vitro
diagnostic device (Sinu-Testâ„¢) for the qualitative detection of the three most common
pathogens responsible for causing bacterial sinusitis.
Trial website
https://clinicaltrials.gov/show/NCT03584737
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jodi L Crutchleo, BS
Address 0 0
Beaufort
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications