Idylla IFV-RSV Panel Clinical Testing

Completed

Conditions studied: Respiratory Tract Infections, Influenza, Human, Respiratory Syncytial Virus Infections

In brief

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

Key facts

Study ID

NCT02786381

Run by

Janssen Pharmaceutica N.V., Belgium

People needed

213

Starts

2015-11-01

Expected to finish

2016-10-01

Last updated by the study team

2016-11-22

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

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 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

Where it is running

• Sacred Heart Hospital - Pensacola — Pensacola, Florida, United States

Full record on ClinicalTrials.gov

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