Idylla IFV-RSV Panel Clinical Testing

NCT02786381 | Completed

• 1 other identifier: CODX0006NAP3001
• Study Type: observational
• Target: 213
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Respiratory Tract Infections; Influenza, Human; Respiratory Syncytial Virus Infections

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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 does not agree to allow study specimens to be used for future research studies

Sponsors & Collaborators

• Janssen Pharmaceutica N.V., Belgium: lead

Study Sites (1)

Sacred Heart Hospital - Pensacola

Pensacola, Florida, 32513, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Nasal swabs (NS); Nasopharyngeal swabs (NP) in viral transport medium (VTM)

MeSH Terms

Conditions

Respiratory Tract Infections; Influenza, Human; Respiratory Syncytial Virus Infections

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Pneumovirus Infections; Paramyxoviridae Infections; Mononegavirales Infections

Study Officials

• Theresa Pattery, MD

  Janssen Diagnostics

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2015
• First Posted: June 1, 2016
• Study Start: November 1, 2015
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: November 22, 2016

Record last verified: 2016-09

Locations

US (1)