NCT00419861

Brief Summary

Influenza vaccination is recommended for all persons age 65 and older. Vaccines that are designed and tested in young healthy adults are often not as effective when used in the elderly. This study will be a one year pilot study to see if it would be practical to conduct a larger study at several other hospitals in the future. Study participants will include 350 men and women greater than or equal to age 50 that are hospitalized at Vanderbilt University or Baptist Community Hospital with acute respiratory symptoms. Study procedures will include questions, one nasal swab, one throat swab, and chart reviews after the patient has been released from the hospital. The nasal and throat swabs will be tested for influenza A and B viruses.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
350

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2006

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 5, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 9, 2007

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed
Last Updated

August 23, 2013

Status Verified

January 1, 2012

Enrollment Period

5 months

First QC Date

January 5, 2007

Last Update Submit

August 22, 2013

Conditions

Keywords

Influenza, surveillance, flu, parent protocol

Study Arms (1)

Group 1

Adults \>/= 50 years of age, hospitalized for respiratory illness in Davidson County, TN.

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Inclusion Criteria: 1. Adults \>/= 50 years of age 2. Resident of Davidson County 3. Admitted to hospital during defined 24 hour periods 4. Patients with one or more of the following admission diagnoses (International Classification of Diseases, 9th Revision Number): pneumonia (480-486), upper respiratory infection (465), bronchitis (466), influenza (487), chronic obstructive pulmonary disease (490 to 492;496), asthma (493), viral illness (079.9)\[13\], dyspnea (786), acute respiratory failure (518.81), pneumonitis due to solids/liquids (507), or fever (780.6) without localizing symptoms. Exclusion Criteria: 1. Adults \>/= 50 years residing outside the surveillance areas 2. Adults \>/= 50 years not admitted on a surveillance day 3. Adults \< 50 years of age 4. Anyone without the above admitting criteria.

You may qualify if:

  • Adults greater than or equal to 50 years of age
  • Resident of Davidson County
  • Admitted to hospital during defined 24 hour periods
  • Patients with one or more of the following admission diagnoses: pneumonia, upper respiratory infection, bronchitis, influenza, chronic obstructive pulmonary disease, asthma, viral illness, dyspnea, acute respiratory failure, pneumonitis due to solids/liquids, or fever without localizing symptoms

You may not qualify if:

  • Adults greater than or equal to 50 years residing outside the surveillance areas
  • Adults greater than or equal to 50 years not admitted on a surveillance day
  • Adults \< 50 years of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt University

Nashville, Tennessee, 37232, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Nasal and throat swabs will be obtained and combined for viral culture, rapid antigen testing, and PCR. Specimens obtained from hospitalized subjects will be tested for influenza A \& B viruses by viral culture, rapid antigen testing and Real-Time Reverse-Transcriptase PCR (RTrtPCR) analysis.

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
NIH

Study Record Dates

First Submitted

January 5, 2007

First Posted

January 9, 2007

Study Start

November 1, 2006

Primary Completion

April 1, 2007

Study Completion

April 1, 2007

Last Updated

August 23, 2013

Record last verified: 2012-01

Locations