Respiratory Virus Outpatient Study (FLU 002 Plus)

Completed

Conditions studied: Influenza and Other Novel Respiratory Viruses

In brief

Following the sudden and unexpected emergence of influenza A(H1N1)pdm09 (2009 H1N1) virus, this observational study was initiated to describe participants seeking medical care in geographically diverse locations with 2009 H1N1 infection and their clinical course over a 14-day period following enrollment. In 2011, as surveillance indicated that 2009 H1N1 virus was co-circulating with other seasonal influenza A and B viruses worldwide, the protocol was expanded to include other influenza A subtypes and influenza B viruses. This version of the protocol further broadens the scope of this observational study. With the recognition that novel respiratory viruses other than novel influenza A viruses, e.g., Middle East Respiratory Syndrome Coronavirus (MERS-CoV), could become prevalent and of major public health importance, the objectives of this protocol have been expanded

Key facts

Study ID

NCT01056354

Run by

University of Minnesota

People needed

11719

Starts

2009-08-01

Expected to finish

2017-05-12

Last updated by the study team

2017-08-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Be ≥ 18 years of age
• Have a signed informed consent by participant
• Have a fever (37.8 degrees C (100 degrees F) or higher on examination or patient-reported fever (37.8 degrees C (100 degrees F) or higher, or feverishness (felt febrile but did not take temperature) in the past 24 hours.
• Have a cough and/or sore throat
• Have suspected influenza or a suspected targeted non-influenza viral respiratory infection

You may not qualify if…

• Current imprisonment, or compulsory detention (involuntary incarceration) for treatment of a psychiatric or physical illness.

Where it is running

• Denver Public Health — Denver, Colorado, United States
• George Washington Medical Faculty Associates — Washington D.C., District of Columbia, United States
• Washington DC VA Medical Center — Washington D.C., District of Columbia, United States
• Infectious Diseases Associates NW FL, PA — Pensacola, Florida, United States
• University of Illinois at Chicago — Chicago, Illinois, United States
• Henry Ford Health System — Detroit, Michigan, United States
• Newland Immunology Center of Excellence (NICE) — Southfield, Michigan, United States
• New Jersey Medical School Adult Clinical Research Center — Newark, New Jersey, United States
• Cornell CRS — New York, New York, United States
• Bronx-Lebanon Hospital Center — The Bronx, New York, United States
• UNC AIDS Clinical Trials Unit — Chapel Hill, North Carolina, United States
• Duke University — Durham, North Carolina, United States
• University of Tennessee College of Medicine — Chattanooga, Tennessee, United States
• University of North Texas Health Science Center — Fort Worth, Texas, United States
• Houston AIDS Research Team — Houston, Texas, United States
• Virginia Commonwealth University — Richmond, Virginia, United States
• Hospital Nacional Profesor Alejandro Posadas — El Palomar, Buenos Aires, Argentina
• Hospital Interzonal General de Agudos Dr. Diego Paroissien — La Matanza, Buenos Aires, Argentina
• Instituto Medico Platense — La Plata, Buenos Aires, Argentina
• Hospital Profesor Bernardo Houssay — Vicente López, Buenos Aires, Argentina
• CAICI (Instituto Centralizado de Assistencia e Investigacion Clinica Integral) — Rosario, Santa Fe Province, Argentina
• Sanatorio Britanico — Rosario, Santa Fe Province, Argentina
• CEMIC — Buenos Aires, Argentina
• FUNCEI — Buenos Aires, Argentina
• UCSD Antiviral Research Center — San Diego, California, United States

Full record on ClinicalTrials.gov

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