Sinusitis BacterialNCT03584737
Point-of-Care Immunoassay for Detection of Bacterial Sinusitis
An observational study of Sinusitis Bacterial, run by ENTvantage Dx at 7 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sinusitis Bacterial
- What is being tested?
- rapid in vitro diagnostic test, bacterial culture and PCR assay
- How many people
- 800 participants
- Where
- 7 sitesUnited States
- Study dates
- 12 Nov 2021to 10 Apr 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients at least 18 years of age with symptoms of bacterial sinusitis from primary care clinics and otolaryngology clinics.
Who may be able to join
- Meets definition of acute sinusitis by Infectious Disease Society of America (2012)
Who cannot join
- 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
Show all 19Show fewer
- 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.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Hillcrest Medical Research
DeLand, Florida, 32720
Optimed Research/Ohio Sinus Institute
Dublin, Ohio, 43016
Kelsey-Seybold Clinic
Houston, Texas, 77025
Tandem Clinical Research
Marrero, Louisiana, 70072
Northwell Health
New Hyde Park, New York, 11042
ENT Allergy & Associates of South Florida
Port Saint Lucie, Florida, 34952
Northern California Research
Sacramento, California, 95821
About this study
Official title: Multi-Center Study of a Point-of-Care Immunoassay for the Detection of Bacterial Sinusitis
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.
Read the detailed description
Mucous specimens will be collected from patients displaying symptoms of acute bacterial sinusitis enrolled by primary care and/or otolaryngology clinics in the United States. Health care professionals not having endoscopy certification will collect specimens using the Entvantage sample collection device. Health care professionals with nasal endoscopy certification or specialty training will collect comparator specimens using an endoscope. Untrained operators with a range of education and training (primary care physician, otolaryngologist, physician assistant, nurse practitioner, registered nurse or other healthcare professional), will perform the Sinu-Test® lateral flow assay in an outpatient setting. Mucous samples will be tested for the presence of 3 bacterial pathogens responsible for sinusitis using the Sinu-Test® in the clinic and by a composite comparator method comprised of standard quantitative bacterial culture with identification (matrix-assisted laser desorption/ionization-Time of Flight (MALDI-TOF) mass spectrometry instrument) and semiquantitative real-time polymerase chain reaction (real-time PCR) of the residual culture sample and the Sinu-Test® residual swab performed by a central laboratory.
- Conditions
- Sinusitis Bacterial
- Being tested
- rapid in vitro diagnostic test, bacterial culture, PCR assay
- Keywords
- acute sinusitis, bacterial sinusitis, point-of-care, in vitro diagnostic device (IVD)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rapid in vitro diagnostic testDiagnostic test
Also called Sinu-Test®
IVD for qualitative detection of 3 bacterial pathogens (Haemophilus influenzae, Moraxella catarrhalis, and Streptococcus pneumoniae)
bacterial cultureDiagnostic test
Quantitative bacterial culture assay with isolate identification by MALDI-TOF.
PCR assayDiagnostic test
Semiquantitative real-time PCR assay
| Study group | Role | What they receive |
|---|---|---|
| Symptomatic for bacterial sinusitis | Samples from participants showing symptoms of bacterial sinusitis tested by rapid in vitro diagnostic test, bacterial culture, and PCR assay Receives: Diagnostic Test: rapid in vitro diagnostic test; Diagnostic Test: bacterial culture; Diagnostic Test: PCR assay |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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.
Measured: 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-)
LR+ is equivalent to the probability of a true positive result divided by the probability of a false positive result. LR- is equivalent to the probability of a false negative result divided by the probability of a true negative result.
Measured: Cumulation of one-time subject sample results obtained in 20-30 minutes for point-of-care test and 3-5 days for lab results
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2018
- Study start12 Nov 2021
- Primary completion9 Apr 2023
- Study completion10 Apr 2023
Why it stopped: Lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sinusitis BacterialStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 800 participants (actual)
Sponsor and investigators
- Lead sponsor
- ENTvantage Dx
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Beaufort
- Responsible party
- Sponsor
- Investigators
- Karen Busch, Study director, Beaufort
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03584737
- Sponsor's protocol ID
- 1001
- Status last verified
- Apr 2023
- First submitted
- 19 Jun 2018
- Last updated
- 12 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Center Study of a Point-of-Care Immunoassay for the Detection of Bacterial Sinusitis
- ClinicalTrials.gov ID
- NCT03584737
- Acronym / sponsor ID
- 1001
- Conditions
- Sinusitis Bacterial
- Keywords
- acute sinusitis, bacterial sinusitis, point-of-care, in vitro diagnostic device (IVD)
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Lack of funding
- Enrolment
- 800 participants (actual)
- Lead sponsor
- ENTvantage DxIndustry (pharma, biotech, devices)
- Collaborators
- Beaufort
- Study start
- 12 Nov 2021 (actual)
- Primary completion
- 9 Apr 2023 (actual)
- Study completion
- 10 Apr 2023 (actual)
- First posted
- 12 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Mucous specimens will be collected from patients displaying symptoms of acute bacterial sinusitis enrolled by primary care and/or otolaryngology clinics in the United States. Health care professionals not having endoscopy certification will collect specimens using the Entvantage sample collection device. Health care professionals with nasal endoscopy certification or specialty training will collect comparator specimens using an endoscope. Untrained operators with a range of education and training (primary care physician, otolaryngologist, physician assistant, nurse practitioner, registered nurse or other healthcare professional), will perform the Sinu-Test® lateral flow assay in an outpatient setting. Mucous samples will be tested for the presence of 3 bacterial pathogens responsible for sinusitis using the Sinu-Test® in the clinic and by a composite comparator method comprised of standard quantitative bacterial culture with identification (matrix-assisted laser desorption/ionization-Time of Flight (MALDI-TOF) mass spectrometry instrument) and semiquantitative real-time polymerase chain reaction (real-time PCR) of the residual culture sample and the Sinu-Test® residual swab performed by a central laboratory.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Symptomatic for bacterial sinusitis | – | Diagnostic Test: rapid in vitro diagnostic test, Diagnostic Test: bacterial culture, Diagnostic Test: PCR assaySamples from participants showing symptoms of bacterial sinusitis tested by rapid in vitro diagnostic test, bacterial culture, and PCR assay |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients at least 18 years of age with symptoms of bacterial sinusitis from primary care clinics and otolaryngology clinics.
Key inclusion criteria (1 listed)
- Meets definition of acute sinusitis by Infectious Disease Society of America (2012)
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rapid in vitro diagnostic testAlso: Sinu-Test®IVD for qualitative detection of 3 bacterial pathogens (Haemophilus influenzae, Moraxella catarrhalis, and Streptococcus pneumoniae) | Diagnostic test | Symptomatic for bacterial sinusitis |
| bacterial cultureQuantitative bacterial culture assay with isolate identification by MALDI-TOF. | Diagnostic test | Symptomatic for bacterial sinusitis |
| PCR assaySemiquantitative real-time PCR assay | Diagnostic test | Symptomatic for bacterial sinusitis |
Primary outcome
Sensitivity (positive predictive agreement) and specificity (negative predictive agreement) of the diagnostic device
Time frame: Cumulation of one-time subject sample results obtained in 20-30 minutes for point-of-care test and 3-5 days for lab results
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.
2 secondary outcomes
Positive predictive value (PPV) and negative predictive value (NPV)
Time frame: 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-)
Time frame: Cumulation of one-time subject sample results obtained in 20-30 minutes for point-of-care test and 3-5 days for lab results
Results and safety
The study was stopped early (reason given: Lack of funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen Busch study director
Beaufort
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sinusitis Bacterial, run by ENTvantage Dx at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Lack of funding). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity (positive predictive agreement) and specificity (negative predictive agreement) of the diagnostic device (time frame: Cumulation of one-time subject sample results obtained in 20-30 minutes for point-of-care test and 3-5 days for lab results). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2023.