Pilot Study of Genotypic Analysis

NCT00421837 | Completed

• 2 other identifiers: 06-0092N01AI80007C
• Study Type: observational
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

Influenza (the flu) is a leading cause of respiratory (breathing) illness that leads to sickness and death during the winter months. A better understanding of why certain people get the flu or get sicker with the flu than other people is important for developing improved vaccines and treatments. This study will look at the genetic makeup (determines each person's specific characteristics and traits) of 50 patients, older than 50, who were hospitalized with flu at Vanderbilt University during the 2006-2007 flu season. Their genetic makeup will be compared with the genetic makeup of 50 people who are not related but were in close daily contact with the flu patient and were not infected with flu virus. The study staff will collect a blood sample (contains genetic material) from each participant (flu patients and their contacts) for comparison. Flu patients will have completed a health survey as part of the previous study, and their contacts will complete a shorter version of this survey.

Conditions

Influenza

Keywords

influenza, flu, genotypic analysis, sub-study

Outcome Measures

Primary Outcomes (1)

• phenotypic analysis

  at analysis

Study Arms (2)

controls

household and other close contacts

cases

elderly (\>55) subjects hospitalized with Influenza

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects \> 55 yo hospitalized with Influenza vs healthy household members and close contacts

You may qualify if:

• Male or female, aged greater than or equal to 50 years
• For SUBJECTS: Enrolled in a Vaccine Treatment and Evaluation Unit (VTEU)-funded surveillance study conducted during the 2006 - 2007 influenza season \[Division of Microbiology and Infectious Diseases (DMID) study 06-0051\]
• Residents of surveillance areas
• For SUBJECTS: Persons who have been hospitalized with respiratory symptoms or fever and polymerase chain reaction (PCR) or culture confirmed influenza virus OR
• For CONTROLS: Living with or in frequent contact with SUBJECT
• For CONTROLS: Genetically unrelated to the SUBJECT
• Willing and able to provide signature documentation of informed consent or parental permission

You may not qualify if:

• For SUBJECTS: Not enrolled in a Vanderbilt led respiratory disease surveillance study \[Division of Microbiology and Infectious Diseases (DMID) study 06-0051\]
• For SUBJECTS: Receipt of blood products in the past 6 months
• Anything in the opinion of the Investigator that would prevent the subject from successfully participating in this study
• For CONTROLS: Influenza infection during the 2006-2007 flu season

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

Vanderbilt University - Pediatric - Vanderbilt Vaccine Research Center

Nashville, Tennessee, 37232-2573, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Sera and saliva

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH

Study Record Dates

• First Submitted: January 11, 2007
• First Posted: January 12, 2007
• Study Start: May 1, 2007
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: August 16, 2013

Record last verified: 2011-04

Locations

US (1)