Respiratory Virus Outpatient Study (FLU 002 Plus)
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|ClinicalTrials.gov Identifier: NCT01056354|
Recruitment Status : Completed
First Posted : January 26, 2010
Last Update Posted : August 18, 2017
|Condition or disease|
|Influenza and Other Novel Respiratory Viruses|
The purpose of this observational study is to describe participants in geographically diverse locations with influenza virus infection and other viral respiratory diseases of public health importance and their clinical course over a 14-day period following enrollment.
Specific objectives related to influenza virus infection are to estimate the percentage of participants who go on to develop severe disease or complications that require hospitalization; to obtain information on risk factors for disease severity; and to establish a central repository of specimens for use in virus characterization, including subtyping, antigenic and genetic analyses, identification of signature mutations associated with antiviral drug resistance, mutational evolution, and additional reassortment.
Specific objectives related to novel non-influenza respiratory viruses of potential major public health importance are to characterize initial cases and their outcomes in order to develop more specific protocols that could inform the prevention and treatment of these new infections
Sample size is open-ended for this observational study. Based on experience to date, it is estimated that 75 sites will participate and will enroll approximately 1,700 patients with influenza each year, about one-half in the Northern Hemisphere and one-half in the Southern Hemisphere. Sites in diverse geographic locations on several continents will participate.
- Participants who meet the eligibility criteria will be enrolled at participating clinical sites.
- At enrollment, consent is signed and information (demographics, medical history (including prior influenza and pneumococcal vaccination), medications (including antivirals) and treatments prescribed will be recorded. A blood sample for serum and plasma will be obtained at enrollment, as well as an upper respiratory tract specimen. The respiratory specimen will be sent for central reverse transcriptase polymerase chain reaction (RT-PCR) testing for influenza.
- Status will be re-assessed at approximately 14 days after enrollment and another blood sample for serum and plasma will be obtained. For participants with a confirmed novel respiratory virus of public health importance, attempts will be made to obtain a sample of the local specimen used to diagnose the infection.
In February 2012, the FLU 004 Genomics protocol v 1.0 was released to the field.
In August 2013 v 2.0 of the protocol was released as INSIGHT Genomics. The protocol was expanded beyond the FLU 002 and FLU 003 studies to include all qualifying INSIGHT studies (list posted on the INSIGHT website, www.insight-trials.org. The purpose of this substudy is to obtain a whole blood sample from which DNA will be extracted to study polymorphisms in immune response genes and other genetic variants that may be associated with an increased risk of disease progression among individuals with infectious diseases of public health importance who are enrolled in qualifying INSIGHT studies.
Participating FLU 002 Plus sites are given the option to also participate in INSIGHT Genomics, which requires a separate protocol registration. Participants, once consented to FLU 002 Plus, will be offered the option to also consent to INSIGHT Genomics, which includes a single whole blood sample collection. Participation in FLU 002 Plus will not be compromised if a participant opts not to participate in INSIGHT Genomics.
|Study Type :||Observational|
|Actual Enrollment :||11719 participants|
|Official Title:||An International Observational Study to Characterize Adults With Influenza or Other Targeted Respiratory Viruses|
|Study Start Date :||August 2009|
|Actual Primary Completion Date :||May 12, 2017|
|Actual Study Completion Date :||May 12, 2017|
Influenza A and subtypes such as H3N2 and 2009 H1N1 or influenza B
Novel respiratory virus-1
MERS-CoV (Middle Eastern Respiratory Syndrome Coronavirus)
Novel respiratory virus-2
SARS-CoV (Severe Acute Respiratory Syndrome Coronavirus)
- Death or Hospitalization [ Time Frame: 14-day period following enrollment ]Death or hospitalization within 14 days of enrollment or the development of one severe complication.
- Days of work/school lost, duration of symptoms, use of antivirals [ Time Frame: 14 days ]
Biospecimen Retention: Samples With DNA
Upper respiratory tract specimen
Serum and plasma
For participants with a confirmed targeted non-influenza respiratory virus, attempts will be made to obtain a sample of the local specimen used to confirm diagnosis.
Whole blood for human genomics (only at FLU 002 Plus sites opting to also participate in INSIGHT Genomics and participant has signed an additional consent)
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): NCT01056354
|Principal Investigator:||James Neaton, Professor||University of Minnesota - Dept Biostatistics|