Respiratory Tract InfectionsRP1NCT02786381
Idylla IFV-RSV Panel Clinical Testing
An observational study of Respiratory Tract Infections and Influenza, Human, run by Janssen Pharmaceutica N.V., Belgium at 1 site in United States.
Trial summary
This clinical study will collect fresh samples and perform laboratory testing on fresh and archived samples as described in the protocol. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Respiratory Tract Infections, Influenza, Human, Respiratory Syncytial Virus Infections
- How many people
- 213 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2015to Oct 2016
- 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: All patients who present with ILI and/or signs/symptoms of RSV Infection who have met all the inclusion and none of the exclusion criteria are considered eligible to participate in the sample collection phase of this study. Specimens may be collected from subjects in either an inpatient or outpatient setting. An outpatient setting includes facilities such as emergency rooms associated with hospitals, large decentralized hospital/commercial labs, urgent cares and/or physician practices currently undertaking diagnostic testing. An inpatient setting is defined as a hospital where patients are admitted (does not include the emergency room associated with the hospital as this will be considered "outpatient" setting). Patient populations from the United States will be evaluated.
Who may be able to join
- Male or Female
- All Ages
- Subject, or legally authorized representative, has provided IRB/EC approved written Informed Consent, privacy (e.g. HIPAA) authorization when required and Assent where applicable prior to any study-related procedure(s) being performed
- Patient presenting with ILI and/or Signs/Symptoms of RSV Infection as defined in this protocol
- Onset of ILI and/or Signs/Symptoms of RSV Infection was ≤ 5 days prior to subject screening (Refer to the definitions for detailed descriptions of ILI and Signs/Symptoms of RSV infection)
- Clinician's determination that illness is due to a viral infection
- Subject agrees to allow study specimens to be used for future studies
Who cannot join
- Onset of Influenza Like Illness (ILI) and/or Signs/Symptoms of RSV Infection was > 5 days prior to subject screening (Refer the definitions for detailed descriptions of ILI and Signs/Symptoms of RSV infection)
- Subject received live intranasal attenuated influenza virus in last 3 weeks (e.g. FluMist, Fluenz)
- Subject received treatment with influenza directed antiviral (e.g. Zanamivir, oseltamivir (Tamiflu), amantadine, rimantadine) in the last 5 days
- The subject was previously enrolled in this study
- Clinician's determination that illness is NOT due to a viral infection (e.g. allergies)
- Subject had a nasal wash within last 8 hours. This exclusion includes any extraction of nasal secretions by nasal suctioning with fluid
- Subject does not agree to allow study specimens to be used for future research studies
Trial locations and contacts
1 site in 1 country.
United States1 site
Sacred Heart Hospital - Pensacola
Pensacola, Florida, 32513
About this study
Official title: Idylla Respiratory (IFV-RSV) Panel Clinical Testing and Sample Collection Protocol in Support of 510(k) Premarket Submission
This clinical study will collect fresh samples and perform laboratory testing on fresh and archived samples as described in the protocol.
Read the detailed description
The Idylla console, instrument, and Respiratory (IFV-RSV) Panel cartridge constitute the Idylla respiratory diagnostic system. The IFV-RSV Panel is an in vitro PCR-based molecular diagnostic assay for the simultaneous qualitative detection of nucleic acids for Influenza A (including H1, 2009 H1N1, H275Y mutation of 2009 H1N1, H3), Influenza B, and Respiratory Syncytial Virus (RSV) (A and B) on nasal swab (NS) direct to cartridge or nasopharyngeal swabs (NP) in viral transport media (VTM) in adults, adolescents, and children.
This clinical study will collect data in support of regulatory submission and the indications for use of the IFV-RSV panel and the Idylla diagnostic system. This protocol will demonstrate that the results of this assay, in conjunction with clinical information, may be used as an aid in the diagnosis of infection with Influenza A, Influenza B, and RSV in persons having both a high and low risk for respiratory viral infection.
During this study, participating sites will collect fresh samples, conduct a Reproducibility Study and test the fresh and previously collected frozen samples from individuals presenting with signs/symptoms of influenza like illness (ILI) and respiratory virus in accordance to the sample collection described in this protocol.
- Medical subject headings
- Respiratory Tract Infections, Influenza, Human, Respiratory Syncytial Virus Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
Product performance as measured by positive and negative agreement to a predicate
Product Performance will be assessed based on samples collected in 2015/2016 season (average of 6 months) and archived samples.
Measured: Specimen collected during the IFV-RSV season 2015/2016 will be tested within 1 day of enrollment. The Product Performance will be assessed at study completion, an average of 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2016 (estimated)
- Study startNov 2015
- Primary completionOct 2016
- Study completionOct 2016
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
- Time perspective
- Cross-sectional
- Enrolment
- 213 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Pharmaceutica N.V., Belgium
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Theresa Pattery, MD, Study director, Janssen Diagnostics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02786381
- Sponsor's protocol ID
- CODX0006NAP3001
- Acronym
- RP1
- Status last verified
- Sep 2016
- First submitted
- 4 Dec 2015
- Last updated
- 22 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Idylla Respiratory (IFV-RSV) Panel Clinical Testing and Sample Collection Protocol in Support of 510(k) Premarket Submission
- ClinicalTrials.gov ID
- NCT02786381
- Acronym / sponsor ID
- RP1 / CODX0006NAP3001
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 213 participants (actual)
- Lead sponsor
- Janssen Pharmaceutica N.V., BelgiumIndustry (pharma, biotech, devices)
- Study start
- Nov 2015
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 1 Jun 2016 (estimated)
- 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 clinical study will collect fresh samples and perform laboratory testing on fresh and archived samples as described in the protocol.
Detailed description
The Idylla console, instrument, and Respiratory (IFV-RSV) Panel cartridge constitute the Idylla respiratory diagnostic system. The IFV-RSV Panel is an in vitro PCR-based molecular diagnostic assay for the simultaneous qualitative detection of nucleic acids for Influenza A (including H1, 2009 H1N1, H275Y mutation of 2009 H1N1, H3), Influenza B, and Respiratory Syncytial Virus (RSV) (A and B) on nasal swab (NS) direct to cartridge or nasopharyngeal swabs (NP) in viral transport media (VTM) in adults, adolescents, and children.
This clinical study will collect data in support of regulatory submission and the indications for use of the IFV-RSV panel and the Idylla diagnostic system. This protocol will demonstrate that the results of this assay, in conjunction with clinical information, may be used as an aid in the diagnosis of infection with Influenza A, Influenza B, and RSV in persons having both a high and low risk for respiratory viral infection.
During this study, participating sites will collect fresh samples, conduct a Reproducibility Study and test the fresh and previously collected frozen samples from individuals presenting with signs/symptoms of influenza like illness (ILI) and respiratory virus in accordance to the sample collection described in this protocol.
Study design
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients who present with ILI and/or signs/symptoms of RSV Infection who have met all the inclusion and none of the exclusion criteria are considered eligible to participate in the sample collection phase of this study. Specimens may be collected from subjects in either an inpatient or outpatient setting. An outpatient setting includes facilities such as emergency rooms associated with hospitals, large decentralized hospital/commercial labs, urgent cares and/or physician practices currently undertaking diagnostic testing. An inpatient setting is defined as a hospital where patients are admitted (does not include the emergency room associated with the hospital as this will be considered "outpatient" setting). Patient populations from the United States will be evaluated.
Key inclusion criteria (7 listed)
- Male or Female
- All Ages
- Subject, or legally authorized representative, has provided IRB/EC approved written Informed Consent, privacy (e.g. HIPAA) authorization when required and Assent where applicable prior to any study-related procedure(s) being performed
- Patient presenting with ILI and/or Signs/Symptoms of RSV Infection as defined in this protocol
- Onset of ILI and/or Signs/Symptoms of RSV Infection was ≤ 5 days prior to subject screening (Refer to the definitions for detailed descriptions of ILI and Signs/Symptoms of RSV infection)
Key exclusion criteria (7 listed)
- Onset of Influenza Like Illness (ILI) and/or Signs/Symptoms of RSV Infection was > 5 days prior to subject screening (Refer the definitions for detailed descriptions of ILI and Signs/Symptoms of RSV infection)
- Subject received live intranasal attenuated influenza virus in last 3 weeks (e.g. FluMist, Fluenz)
- Subject received treatment with influenza directed antiviral (e.g. Zanamivir, oseltamivir (Tamiflu), amantadine, rimantadine) in the last 5 days
- The subject was previously enrolled in this study
- Clinician's determination that illness is NOT due to a viral infection (e.g. allergies)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Product performance as measured by positive and negative agreement to a predicate
Time frame: Specimen collected during the IFV-RSV season 2015/2016 will be tested within 1 day of enrollment. The Product Performance will be assessed at study completion, an average of 6 months.
Product Performance will be assessed based on samples collected in 2015/2016 season (average of 6 months) and archived samples.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2016.
Related trials for Respiratory Tract Infections
RecruitingObservational study
Collection of Lung Fluid and Tissue Samples for Research
Leukocyte Disorders, Respiratory Tract Diseases
RecruitingPhase 3
A Study of Secutrelvir in Participants With Coronavirus Disease 2019 (COVID-19) Who Are at High Risk for Progression to Severe Disease
SARS-CoV-2
Active, not recruitingPhase 1/2
Safety and Immunogenicity Study of SCB-1022 and SCB-1033 in Healthy Older Adults
RSV Infection, Human Metapneumovirus Infection
RecruitingObservational study
Viral Infections in Healthy and Immunocompromised Hosts
Anogenital Herpes, COVID-19
Not yet recruiting
Multimodal Stewardship Programme to Improve Antibiotic Prescribing for Children With Lower Respiratory Tract Infections
Bronchitis, Acute, Community-acquired Pneumonia
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.
Theresa Pattery, MD study director
Janssen 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 Influenza, Human, run by Janssen Pharmaceutica N.V., Belgium 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 7 inclusion and 7 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: finished, as of the sponsor's last update on 22 Nov 2016. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Product performance as measured by positive and negative agreement to a predicate (time frame: Specimen collected during the IFV-RSV season 2015/2016 will be tested within 1 day of enrollment. The Product Performance will be assessed at study completion, an average of 6 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 22 Nov 2016.