Respiratory Tract InfectionsNCT03299283
Specimen Collection and Transport Workflow Evaluations for CLIA-waived Molecular Testing
An observational study of Respiratory Tract Infections and Gastrointestinal Infection, run by BioFire Diagnostics, LLC at 1 site in United States.
Trial summary
The purpose of this study is two-fold. In the first phase, the goal is to characterize the stability of respiratory (nasal swab, nasopharyngeal swab, and throat swab; NS, NPS, TS) and stool (raw stool and rectal swab) specimens collected using various standard, medically established procedures with and without… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Respiratory Tract Infections, Gastrointestinal Infection
- What is being tested?
- BioFire test platform
- How many people
- 4,000 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Oct 2017to 30 Dec 2019
- 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
- No healthy volunteers
- Child, Adult, Older adult
Study population: Subjects present to ED or urgent care centers with signs/symptoms of respiratory tract or gastrointestinal infection
Who may be able to join
- Subject presents with signs/symptoms of respiratory infection including but not limited to fever, cough, sore throat (pharyngitis), runny nose, myalgia, headache, chills, or fatigue. OR Subject presents with suspected gastroenteritis (e.g. diarrhea, vomiting, nausea, etc.) with duration of symptoms less than or equal to 7 days
- If age 18 or over, subject provides written informed consent
- If under the age of 18, parental permission and assent (as appropriate) is obtained
- Subject is willing and able to provide at least two (up to three) specimens: any combination of NS, NPS, or TS OR rectal swab or stool
Who cannot join
- Subject is unable to provide consent or parental permission and assent (as appropriate) cannot be obtained
- Subject is unable or unwilling to provide two specimens
- Subject's health care provider determines that specimen collection represents an unacceptable risk
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is two-fold. In the first phase, the goal is to characterize the stability of respiratory (nasal swab, nasopharyngeal swab, and throat swab; NS, NPS, TS) and stool (raw stool and rectal swab) specimens collected using various standard, medically established procedures with and without transport media and tested at various time points and under different temperature conditions, and also to look at variation between repeat sampling events. The intention is for these data to support decisions made by BioFire regarding the appropriate specimen type and handling guidelines for future tests. In the second phase of the study, collection and transport conditions identified in Phase 1 will be used to collect specimens for pilot performance evaluations of a new molecular diagnostic test.
Read the detailed description
This evaluation will be initiated at several sites in the US. In the first phase of the study, multiple specimens will be collected from each subject and tested using various pre-analytical techniques. Current BioFire FilmArray test panels will be used to assay each specimen and evaluate the multiple variables: repeat sampling, native specimen stability, or other post-collection variables. In the second phase of the study only two specimens will be collected from each subject: one for testing with the new test (using handling procedures identified in Phase 1) and another for testing with the reference method. Up to 2,000 subjects will be enrolled across all sites in each phase (up to 4,000 subjects total). Enrollment is expected to last approximately 18 months to cover both phases of the study. All specimens and subject data will be de-identified and coded. Prior to study initiation, each participating site will have the necessary Institutional Review Board (IRB) reviews. Specimens in both phases will be tested at the study site using various BioFire test platforms and cartridges.
- Being tested
- BioFire test platform
- Medical subject headings
- Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BioFire test platformDiagnostic test
Analysis of analyte stability under various conditions as measured by BioFire test platforms
| Study group | Role | What they receive |
|---|---|---|
| Respiratory/Pharyngitis | Subject presents with signs/symptoms of respiratory infection including but not limited to fever, cough, sore throat (pharyngitis), runny nose, myalgia, headache, chills, or fatigue Receives: Diagnostic Test: BioFire test platform | |
| Gastrointestinal | Subject presents with suspected gastroenteritis (e.g. diarrhea, vomiting, nausea, etc.) with duration of symptoms less than or equal to 7 days Receives: Diagnostic Test: BioFire test platform |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analyte stability (as measured by nucleic acid detection)
Sensitivity (or positive percent agreement) and specificity (or negative percent agreement) of the assays comprising the FilmArray Panel with respect to reference methods will investigate analyte stability for the various pre-analytical steps. Analyte stability will be measured by assessing nucleic acid level using real-time PCR.
Measured: Through completion of Phase 1 (approximartely 9 months)
Secondary outcomes (1)
Device performance relative to reference methods
Sensitivity (or positive percent agreement) and specificity (or negative percent agreement) of the assays comprising the FilmArray Panel with respect to reference methods will determine device performance relative to reference method(s) i.e. if an anlyte is detected (or not) by each method (presence or absence)
Measured: Through completion of Phase 2 (approximately 9 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2017
- Study start5 Oct 2017
- Primary completion30 Oct 2019 (estimated)
- Study completion30 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Tract InfectionsStudies 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
- Prospective
- Enrolment
- 4,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BioFire Diagnostics, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kevin Bourzac, PhD, Study director, BioFire Diagnostics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03299283
- Sponsor's protocol ID
- 804 Pilot
- Status last verified
- Jan 2019
- First submitted
- 18 Jul 2017
- Last updated
- 15 Jan 2019
- 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 15 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Specimen Collection and Transport Workflow Evaluations for CLIA-waived Molecular Testing
- ClinicalTrials.gov ID
- NCT03299283
- Acronym / sponsor ID
- 804 Pilot
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- BioFire Diagnostics, LLCIndustry (pharma, biotech, devices)
- Study start
- 5 Oct 2017 (actual)
- Primary completion
- 30 Oct 2019 (estimated)
- Study completion
- 30 Dec 2019 (estimated)
- First posted
- 3 Oct 2017 (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 purpose of this study is two-fold. In the first phase, the goal is to characterize the stability of respiratory (nasal swab, nasopharyngeal swab, and throat swab; NS, NPS, TS) and stool (raw stool and rectal swab) specimens collected using various standard, medically established procedures with and without transport media and tested at various time points and under different temperature conditions, and also to look at variation between repeat sampling events. The intention is for these data to support decisions made by BioFire regarding the appropriate specimen type and handling guidelines for future tests. In the second phase of the study, collection and transport conditions identified in Phase 1 will be used to collect specimens for pilot performance evaluations of a new molecular diagnostic test.
Detailed description
This evaluation will be initiated at several sites in the US. In the first phase of the study, multiple specimens will be collected from each subject and tested using various pre-analytical techniques. Current BioFire FilmArray test panels will be used to assay each specimen and evaluate the multiple variables: repeat sampling, native specimen stability, or other post-collection variables. In the second phase of the study only two specimens will be collected from each subject: one for testing with the new test (using handling procedures identified in Phase 1) and another for testing with the reference method. Up to 2,000 subjects will be enrolled across all sites in each phase (up to 4,000 subjects total). Enrollment is expected to last approximately 18 months to cover both phases of the study. All specimens and subject data will be de-identified and coded. Prior to study initiation, each participating site will have the necessary Institutional Review Board (IRB) reviews. Specimens in both phases will be tested at the study site using various BioFire test platforms and cartridges.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Respiratory/Pharyngitis | – | Diagnostic Test: BioFire test platformSubject presents with signs/symptoms of respiratory infection including but not limited to fever, cough, sore throat (pharyngitis), runny nose, myalgia, headache, chills, or fatigue |
| Gastrointestinal | – | Diagnostic Test: BioFire test platformSubject presents with suspected gastroenteritis (e.g. diarrhea, vomiting, nausea, etc.) with duration of symptoms less than or equal to 7 days |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects present to ED or urgent care centers with signs/symptoms of respiratory tract or gastrointestinal infection
Key inclusion criteria (4 listed)
- Subject presents with signs/symptoms of respiratory infection including but not limited to fever, cough, sore throat (pharyngitis), runny nose, myalgia, headache, chills, or fatigue. OR Subject presents with suspected gastroenteritis (e.g. diarrhea, vomiting, nausea, etc.) with duration of symptoms less than or equal to 7 days
- If age 18 or over, subject provides written informed consent
- If under the age of 18, parental permission and assent (as appropriate) is obtained
- Subject is willing and able to provide at least two (up to three) specimens: any combination of NS, NPS, or TS OR rectal swab or stool
Key exclusion criteria (3 listed)
- Subject is unable to provide consent or parental permission and assent (as appropriate) cannot be obtained
- Subject is unable or unwilling to provide two specimens
- Subject's health care provider determines that specimen collection represents an unacceptable risk
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 |
|---|---|---|
| BioFire test platformAnalysis of analyte stability under various conditions as measured by BioFire test platforms | Diagnostic test | Gastrointestinal, Respiratory/Pharyngitis |
Primary outcome
Analyte stability (as measured by nucleic acid detection)
Time frame: Through completion of Phase 1 (approximartely 9 months)
Sensitivity (or positive percent agreement) and specificity (or negative percent agreement) of the assays comprising the FilmArray Panel with respect to reference methods will investigate analyte stability for the various pre-analytical steps. Analyte stability will be measured by assessing nucleic acid level using real-time PCR.
1 secondary outcome
Device performance relative to reference methods
Time frame: Through completion of Phase 2 (approximately 9 months)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2019.
- 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.
Kevin Bourzac, PhD study director
BioFire Diagnostics
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 Respiratory Tract Infections and Gastrointestinal Infection, run by BioFire Diagnostics, LLC 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 15 Jan 2019. 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?
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?
Analyte stability (as measured by nucleic acid detection) (time frame: Through completion of Phase 1 (approximartely 9 months)). 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 15 Jan 2019.