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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00170495
Other study ID # 04-049
Secondary ID H-14802
Status Terminated
Phase N/A
First received September 12, 2005
Last updated August 26, 2010
Start date September 2004
Est. completion date July 2006

Study information

Verified date September 2008
Source National Institute of Allergy and Infectious Diseases (NIAID)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Observational

Clinical Trial Summary

This study is designed to assess the causes and impact of acute respiratory illness (common colds, flu, bronchitis, pneumonia) in adults age 65 and older. One of the ways to determine the virus causing a particular illness is to get a blood specimen when a person is sick and again later and look for the body's specific responses that identify the virus. Approximately 3000 subjects will be evaluated and their medical records assessed for details of recent illness and general health to help in understanding the subjects' current illness.


Description:

The purpose of this study is to determine the role of respiratory viruses in the etiology of medically attended acute respiratory illness in elderly populations and to assess the impact of these illnesses. Ambulatory elders presenting for health care with an acute respiratory illness will be recruited. Nose and throat swab specimens will be collected to test for one of the respiratory viruses, and acute and convalescent blood specimens will be collected to test for increases in specific antibody. Specimens will be collected within seven days of the onset of illness and then 1 month later for comparison specimens. A brief questionnaire will accompany the specimens, and more complete data on the illness and consequences will be obtained from the medical record. The pattern of illnesses by virus and their severity and duration will be determined.


Recruitment information / eligibility

Status Terminated
Enrollment 3000
Est. completion date July 2006
Est. primary completion date July 2006
Accepts healthy volunteers No
Gender Both
Age group 65 Years and older
Eligibility Inclusion Criteria:

1. 65 years of age or older

2. Presentation to the geriatric clinic with an acute respiratory illness of less than 7 days' duration.

Exclusion Criteria:

1. Presentation to the geriatric clinic with a history of a respiratory illness of greater than 7 days' duration.

2. Physician/physician assistant judgment that the respiratory complaints do not represent an acute infection.

3. Patient declines to permit specimen collection.

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Locations

Country Name City State
United States Baylor College of Medicine Houston Texas

Sponsors (1)

Lead Sponsor Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States, 

See also
  Status Clinical Trial Phase
Terminated NCT00133432 - Zinc and Pneumonia Protocol Phase 3
Completed NCT00100373 - RSV Challenge in Healthy Adults N/A
Completed NCT00246480 - RSV Disease in the Elderly