Clinical Trial Sponsors: University of Minnesota

  Source:		NCT01056354

    		Respiratory Virus Outpatient Study (FLU 002


			First Update January 25, 2010
			Last Update August 15, 2017

			Brief Summary
			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

			Detailed Description
			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.
			Study Plan: - 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

			19423869 Emergence of a novel swine-origin
			influenza A (H1N1) virus in humans.

			23727167 Clinical features and viral diagnosis
			of two cases of infection with Middle East Respiratory Syndrome
			coronavirus: a report of nosocomial transmission.

			23782859 Clinical features and virological
			analysis of a case of Middle East respiratory syndrome
			coronavirus infection.

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