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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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 / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2006

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2007

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2007

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 5, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 5, 2007

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 9, 2007

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 23, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 22, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 06-0051

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