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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT03584737




Registration number
NCT03584737
Ethics application status
Date submitted
19/06/2018
Date registered
12/07/2018
Date last updated
12/04/2023

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


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
Semiquantitative real-time PCR assay
Intervention code [1] 0 0
Diagnosis / Prognosis
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Sensitivity (positive predictive agreement) and specificity (negative predictive agreement) of the diagnostic device
Timepoint [1] 0 0
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 outcome [1] 0 0
Positive predictive value (PPV) and negative predictive value (NPV)
Timepoint [1] 0 0
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 outcome [2] 0 0
Positive likelihood ratio (LR+) and negative likelihood ratio (LR-)
Timepoint [2] 0 0
Cumulation of one-time subject sample results obtained 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
Sex
Both males and females
Can healthy volunteers participate?
No
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
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
12/11/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
10/04/2023
Sample size
Target
Accrual to date
Final
800
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Louisiana
Country [4] 0 0
United States of America
State/province [4] 0 0
New York
Country [5] 0 0
United States of America
State/province [5] 0 0
Ohio
Country [6] 0 0
United States of America
State/province [6] 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

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-Test®) for the qualitative detection of the three most common
pathogens responsible for causing bacterial sinusitis.
Trial website
https://clinicaltrials.gov/ct2/show/NCT03584737
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

Contacts
Principal investigator
Name 0 0
Karen Busch
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

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT03584737