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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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:
Condition category
Condition code

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes

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
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
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)

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
ENTvantage Dx
Address
Country

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/study/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/study/NCT03584737