Inpatient Influenza Surveillance

August 22, 2013 updated by: National Institute of Allergy and Infectious Diseases (NIAID)

Inpatient Surveillance for Influenza Infections in Adults

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.

Study Overview

Status

Completed

Conditions

Detailed Description

Influenza vaccination has been recommended for all persons greater than or equal to age 65, recent studies have questioned the efficacy of the vaccine in the aging population. The willingness to test new vaccines depends on a convincing demonstration of a significant burden of disease despite current vaccine policies. If comprehensive surveillance could be performed in a well defined population of adults over 50 years of age hospitalized with acute respiratory illness or fever, the precise burden of influenza illness in this age group could be determined and the risk factors associated with influenza infection established. This study will be a one year pilot study. Study participants will include 350 adults greater than and equal to 50 years of age hospitalized at Vanderbilt University or a local community hospital, Baptist Hospital, with acute respiratory symptoms or fever. The purpose of the study is to determine the feasibility of conducting a larger surveillance study in several other hospitals. Specific aims are: 1) to perform population-based surveillance to determine the etiology and burden of acute viral respiratory diseases or fever among hospitalized adults greater than or equal to 50 years of age and 2) to identify risk factors associated with hospitalization for vaccine-preventable respiratory disease in adults greater than or equal to 50 years of age. During November 2006 through April 2007, recruitment will occur 2 days per week and will increase to 4 days per week during the defined influenza season based on local surveillance. Following informed consent, there will be 3 parts to data collection: (1) series of brief questions; (2) one nasal and one throat swab will be collected and; (3) chart abstractions performed after discharge. Nasal and throat swabs will be tested for influenza A and B viruses by both viral culture, rapid antigen testing, and Real-Time Reverse-Transcriptase PCR (RTrtPCR) analysis. The primary endpoint of the study is the incidence of hospitalizations due to influenza virus by age, sex, and race in adults greater or equal to than 50 years of age. This study is linked to DMID protocol 06-0092.

Study Type

Observational

Enrollment (Anticipated)

350

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-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.

Description

Inclusion Criteria:

  1. Adults greater than or equal to 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: 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

Exclusion Criteria:

  1. Adults greater than or equal to 50 years residing outside the surveillance areas
  2. Adults greater than or equal to 50 years not admitted on a surveillance day
  3. Adults < 50 years of age

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Group 1
Adults >/= 50 years of age, hospitalized for respiratory illness in Davidson County, TN.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2006

Primary Completion (Actual)

April 1, 2007

Study Completion (Actual)

April 1, 2007

Study Registration Dates

First Submitted

January 5, 2007

First Submitted That Met QC Criteria

January 5, 2007

First Posted (Estimate)

January 9, 2007

Study Record Updates

Last Update Posted (Estimate)

August 23, 2013

Last Update Submitted That Met QC Criteria

August 22, 2013

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 06-0051

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Influenza

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Belgium

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe