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Idylla IFV-RSV Panel Clinical Testing (RP1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02786381
Recruitment Status : Completed
First Posted : June 1, 2016
Last Update Posted : November 22, 2016
Sponsor:
Information provided by (Responsible Party):
Janssen Pharmaceutica N.V., Belgium

Brief Summary:
This clinical study will collect fresh samples and perform laboratory testing on fresh and archived samples as described in the protocol.

Condition or disease
Respiratory Tract Infections Influenza, Human Respiratory Syncytial Virus Infections

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.

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Study Type : Observational
Actual Enrollment : 213 participants
Time Perspective: Cross-Sectional
Official Title: Idylla Respiratory (IFV-RSV) Panel Clinical Testing and Sample Collection Protocol in Support of 510(k) Premarket Submission
Study Start Date : November 2015
Actual Primary Completion Date : October 2016
Actual Study Completion Date : October 2016



Primary Outcome Measures :
  1. 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.


Biospecimen Retention:   Samples Without DNA
Nasal swabs (NS); Nasopharyngeal swabs (NP) in viral transport medium (VTM)


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
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.
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02786381


Locations
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United States, Florida
Sacred Heart Hospital - Pensacola
Pensacola, Florida, United States, 32513
Sponsors and Collaborators
Janssen Pharmaceutica N.V., Belgium
Investigators
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Study Director: Theresa Pattery, MD Janssen Diagnostics
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Responsible Party: Janssen Pharmaceutica N.V., Belgium
ClinicalTrials.gov Identifier: NCT02786381    
Other Study ID Numbers: CODX0006NAP3001
First Posted: June 1, 2016    Key Record Dates
Last Update Posted: November 22, 2016
Last Verified: September 2016
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Respiratory Tract Infections
Respiratory Syncytial Virus Infections
Influenza, Human
Virus Diseases
Respiratory Tract Diseases
Pneumovirus Infections
Paramyxoviridae Infections
Mononegavirales Infections
RNA Virus Infections
Orthomyxoviridae Infections