Influenza ANCT05928507
FINDER® Instrument and FINDER® FLU A/B, RSV, SARS-CoV-2 Test Clinical Evaluation Protocol
An observational study of Influenza A and Influenza Type B, run by Baebies, Inc. at 1 site in United States.
Trial summary
The goal of this observational study is to compare the FINDER FLU A/B, RSV, SARS-CoV-2 Test to an FDA-cleared device. The study will utilize prospectively collected de-identified nasopharyngeal samples obtained from both pediatric and adult populations from subjects presenting with symptoms of respiratory illness. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Influenza A, Influenza Type B, SARS CoV 2 Infection
- What is being tested?
- Diagnostic Test for identification of influenzas A, influenzas B, RSV and SARS-CoV-2 infections
- How many people
- 2,500 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Oct 2023to 30 Mar 2024
- How long will I take part?
- 7 Days
- 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: The study population for this protocol will consist of samples collected from adult and pediatric individuals with signs and symptoms of respiratory disorders.
Who may be able to join
- Nasopharyngeal samples will be collected using swabs and placed in liquid transport media.
- The samples are obtained from individuals exhibiting respiratory signs and symptoms.
- These samples are collected as part of standard differential diagnostic procedures.
- A minimum sample volume of 1.5 mL is required for testing purposes.
Who cannot join
- de-identified samples that have not been stored in accordance with CDC recommendations for nasopharyngeal (NP) sample storage.
- Samples obtained from subjects who do not exhibit signs or symptoms of respiratory illness.
- The sample with a volume is less than 1.5 mL
Trial locations and contacts
1 site in 1 country.
About this study
Official title: CSP0010 FINDER® Instrument and FINDER® FLU A/B, RSV, SARS-CoV-2 Test Clinical Evaluation Protocol
The goal of this observational study is to compare the FINDER FLU A/B, RSV, SARS-CoV-2 Test to an FDA-cleared device. The study will utilize prospectively collected de-identified nasopharyngeal samples obtained from both pediatric and adult populations from subjects presenting with symptoms of respiratory illness.
The main question it aims to answer are:
- the study is to validate that the device intended use in terms that the device's performance meets the criteria for substantial equivalence with a predicate and satisfies the statutory criteria for Clinical Laboratory Improvement Amendments (CLIA) waiver.
- Conditions
- Influenza A, Influenza Type B, SARS CoV 2 Infection, RSV Infection
- Being tested
- Diagnostic Test for identification of influenzas A, influenzas B, RSV and SARS-CoV-2 infections
- Medical subject headings
- COVID-19, Respiratory Syncytial Virus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic Test for identification of influenzas A, influenzas B, RSV and SARS-CoV-2 infectionsDiagnostic test
The FINDER FLU A/B, RSV, SARS-CoV-2 Test real-time RT-PCR test for the qualitative detection of viral RNA from RSV, FLU A, FLU B and SARS-CoV-2 in nasopharyngeal (NP) specimens from individuals suspected of respiratory tract infection by their healthcare provider.
Nucleic acids from respiratory viruses identified by this test are typically detectable in nasopharyngeal swabs (NP) during the acute phase of infection. The detection and identification of specific viral nucleic acids from individuals signs is an indication of the presence of the identified microorganism and assist in the diagnosis of respiratory infection when considered alongside other clinical and epidemiological information.
| Study group | Role | What they receive |
|---|---|---|
| Adult Category 1 -fresh prospective | NP swabs from the Adult population >17 years, collected prospectively from adults presenting with symptoms of respiratory illness. Tested within 72 hours of collection. Receives: Diagnostic Test: Diagnostic Test for identification of influenzas A, influenzas B, RSV and SARS-CoV-2 infections | |
| Pediatric Category 1 -fresh prospective | P swabs from the pediatric population <=17 years, collected prospectively from pediatrics presenting with symptoms of respiratory illness. Tested within 72 hours of collection. Receives: Diagnostic Test: Diagnostic Test for identification of influenzas A, influenzas B, RSV and SARS-CoV-2 infections | |
| Adult Category 2 -frozen prospective | NP swabs from the Adult population >17 years, were collected prospectively from adults presenting with symptoms of respiratory illness. Frozen following CLSI guidelines to be Tested at a later time point approximately 3 months. Receives: Diagnostic Test: Diagnostic Test for identification of influenzas A, influenzas B, RSV and SARS-CoV-2 infections | |
| Pediatric Category 2 -frozen prospective | NP swabs from the pediatric population >17 years, were collected prospectively from pediatrics presenting with symptoms of respiratory illness. Frozen following CLSI guidelines to be tested at a later time point approximately 3 months. Receives: Diagnostic Test: Diagnostic Test for identification of influenzas A, influenzas B, RSV and SARS-CoV-2 infections |
What is being measured
The primary outcome is the main question the study is designed to answer.
Qualitative detection of viral RNA from Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), Influenza A (H1N1 and H3N2 subtypes), Influenza B (Victoria and Yamagata strains), and Respiratory Syncytial Virus (A and B subtypes)
Qualitative detection of viral RNA from Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), Influenza A (H1N1 and H3N2 subtypes), Influenza B (Victoria and Yamagata strains), and Respiratory Syncytial Virus (A and B subtypes) in nasopharyngeal (NP) specimens from individuals suspected of respiratory tract infection by their healthcare provider.for adults and pediatrics when compared to a known FDA cleared assay/ instrument combination.
Measured: within 72 hours of collection of NP swab
Secondary outcomes (1)
CLIA Waived results and clinical laboratory result
Characterization of the performance of the FINDER device when used at a CLIA-waived location and when used in a clinical laboratory location.
Measured: within 72 hours of collection of NP swab
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study start2 Oct 2023 (estimated)
- Primary completion29 Feb 2024 (estimated)
- Study completion30 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Influenza AStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 2,500 participants (estimated)
- Target duration
- 7 Days
Sponsor and investigators
- Lead sponsor
- Baebies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Candice Prowse, Study director, Baebies, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05928507
- Sponsor's protocol ID
- CSP0010
- Status last verified
- Jun 2023
- First submitted
- 26 Jun 2023
- Last updated
- 3 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: No plan to share data. The data is in support of a 510K
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CSP0010 FINDER® Instrument and FINDER® FLU A/B, RSV, SARS-CoV-2 Test Clinical Evaluation Protocol
- ClinicalTrials.gov ID
- NCT05928507
- Acronym / sponsor ID
- CSP0010
- Conditions
- Influenza A, Influenza Type B, SARS CoV 2 Infection, RSV Infection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- Baebies, Inc.Industry (pharma, biotech, devices)
- Study start
- 2 Oct 2023 (estimated)
- Primary completion
- 29 Feb 2024 (estimated)
- Study completion
- 30 Mar 2024 (estimated)
- First posted
- 3 Jul 2023 (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.
The goal of this observational study is to compare the FINDER FLU A/B, RSV, SARS-CoV-2 Test to an FDA-cleared device. The study will utilize prospectively collected de-identified nasopharyngeal samples obtained from both pediatric and adult populations from subjects presenting with symptoms of respiratory illness.
The main question it aims to answer are:
- the study is to validate that the device intended use in terms that the device's performance meets the criteria for substantial equivalence with a predicate and satisfies the statutory criteria for Clinical Laboratory Improvement Amendments (CLIA) waiver.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 7 Days
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Adult Category 1 -fresh prospective | – | Diagnostic Test: Diagnostic Test for identification of influenzas A, influenzas B, RSV and SARS-CoV-2 infectionsNP swabs from the Adult population >17 years, collected prospectively from adults presenting with symptoms of respiratory illness. Tested within 72 hours of collection. |
| Pediatric Category 1 -fresh prospective | – | Diagnostic Test: Diagnostic Test for identification of influenzas A, influenzas B, RSV and SARS-CoV-2 infectionsP swabs from the pediatric population <=17 years, collected prospectively from pediatrics presenting with symptoms of respiratory illness. Tested within 72 hours of collection. |
| Adult Category 2 -frozen prospective | – | Diagnostic Test: Diagnostic Test for identification of influenzas A, influenzas B, RSV and SARS-CoV-2 infectionsNP swabs from the Adult population >17 years, were collected prospectively from adults presenting with symptoms of respiratory illness. Frozen following CLSI guidelines to be Tested at a later time point approximately 3 months. |
| Pediatric Category 2 -frozen prospective | – | Diagnostic Test: Diagnostic Test for identification of influenzas A, influenzas B, RSV and SARS-CoV-2 infectionsNP swabs from the pediatric population >17 years, were collected prospectively from pediatrics presenting with symptoms of respiratory illness. Frozen following CLSI guidelines to be tested at a later time point approximately 3 months. |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- The study population for this protocol will consist of samples collected from adult and pediatric individuals with signs and symptoms of respiratory disorders.
Key inclusion criteria (4 listed)
- Nasopharyngeal samples will be collected using swabs and placed in liquid transport media.
- The samples are obtained from individuals exhibiting respiratory signs and symptoms.
- These samples are collected as part of standard differential diagnostic procedures.
- A minimum sample volume of 1.5 mL is required for testing purposes.
Key exclusion criteria (3 listed)
- de-identified samples that have not been stored in accordance with CDC recommendations for nasopharyngeal (NP) sample storage.
- Samples obtained from subjects who do not exhibit signs or symptoms of respiratory illness.
- The sample with a volume is less than 1.5 mL
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 |
|---|---|---|
| Diagnostic Test for identification of influenzas A, influenzas B, RSV and SARS-CoV-2 infectionsThe FINDER FLU A/B, RSV, SARS-CoV-2 Test real-time RT-PCR test for the qualitative detection of viral RNA from RSV, FLU A, FLU B and SARS-CoV-2 in nasopharyngeal (NP) specimens from individuals suspected of respiratory tract infection by their healthcare provider. Nucleic acids from respiratory viruses identified by this test are typically detectable in nasopharyngeal swabs (NP) during the acute phase of infection. The detection and identification of specific viral nucleic acids from individuals signs is an indication of the presence of the identified microorganism and assist in the diagnosis of respiratory infection when considered alongside other clinical and epidemiological information. | Diagnostic test | Adult Category 1 -fresh prospective, Adult Category 2 -frozen prospective, Pediatric Category 1 -fresh prospective, Pediatric Category 2 -frozen prospective |
Primary outcome
Qualitative detection of viral RNA from Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), Influenza A (H1N1 and H3N2 subtypes), Influenza B (Victoria and Yamagata strains), and Respiratory Syncytial Virus (A and B subtypes)
Time frame: within 72 hours of collection of NP swab
Qualitative detection of viral RNA from Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), Influenza A (H1N1 and H3N2 subtypes), Influenza B (Victoria and Yamagata strains), and Respiratory Syncytial Virus (A and B subtypes) in nasopharyngeal (NP) specimens from individuals suspected of respiratory tract infection by their healthcare provider.for adults and pediatrics when compared to a known FDA cleared assay/ instrument combination.
1 secondary outcome
CLIA Waived results and clinical laboratory result
Time frame: within 72 hours of collection of NP swab
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2023.
- Individual participant dataSharing planned: No. No plan to share data. The data is in support of a 510K
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Healthy Participants
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.
Candice Prowse study director
Baebies, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Influenza A and Influenza Type B, run by Baebies, Inc. at 1 site 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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 3 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Candice Prowse (7038632530, clinical@baebies.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Qualitative detection of viral RNA from Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), Influenza A (H1N1 and H3N2 subtypes), Influenza B (Victoria and Yamagata strains), and Respiratory Syncytial Virus (A and B subtypes) (time frame: within 72 hours of collection of NP swab). 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 3 Jul 2023.