Ignite Creation Date:
2024-05-05 @ 12:06 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00246480
Status:
COMPLETED
Last Update Posted:
2019-02-04
First Post:
2005-10-27
Brief Title:
RSV Disease in the Elderly
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Pathogenesis of RSV Disease in the Elderly
Status:
COMPLETED
Status Verified Date:
2011-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Respiratory syncytial virus RSV causes sickness and deaths in older people every winter This study will investigate how aging affects the bodys immune response bodys response to disease to RSV About 2000 people age 21 and older who reside in the upstate NY area will be recruited Two groups of subjects will be studied The 1st group of volunteers will be recruited prior to the start of RSV season in year 1 of the study These volunteers will include healthy people and people with various medical conditions The 2nd group of volunteers will be patients admitted to Rochester General Hospital for acute respiratory illness Procedures will include drawing blood from a vein in the arm 2 tablespoons collecting nasal swabs and collecting sputum Volunteers may participate in study related procedures for up to 3 years
Detailed Description:
Respiratory infections account for significant excess morbidity and mortality among older people each winter Influenza A virus and Respiratory Syncytial Virus RSV have emerged as two of the most important viruses for this age group The resultant morbidity and mortality among these populations is substantial Natural RSV infection in adults of various ages with mild moderate and severe RSV disease will be evaluated in order to accomplish the following primary objectives to assess the effect of aging on the immune response to natural RSV infection to assess the effect of aging on the clearance of RSV infection to assess the effect of aging on the innate immune response to natural RSV infection to assess the possibility of virus spread to the lower airways and to assess the role of the RSV-specific immune response in the pathogenesis of severe disease Study participants will include approximately 2000 persons male and female greater than or equal to age 21 including healthy persons persons with common medical conditions ie hypertension diabetes thyroid conditions arthritis coronary artery disease skin cancer etc persons with underlying chronic pulmonary or cardiac conditions and persons with signs and symptoms of acute respiratory tract illness who reside in the Upstate New York area A prospective cohort of 800 persons will be recruited prior to the onset of RSV season in year one and followed for respiratory illnesses during each RSV season for three years or until the subject has a documented RSV illness This group will contain persons of various ages and a spectrum of medical conditions This population will be used to evaluate age-related differences in the immune response to RSV and viral shedding patternsThese volunteers are expected to provide primarily cases of mild to moderately severe RSV disease A second group of subjects with signs and symptoms of acute respiratory tract illness will be recruited from the Lifetime After hours Urgent Care Center Rochester General Hospital emergency room and inpatient medical service Those identified with RSV infection will provide cases of moderate to severe RSV disease At the end of RSV season a control group will be selected This group will be comprised from subjects chosen from the prospective cohort who did not have an RSV infection during that winter season Controls will be matched by age and underlying conditions for each of the RSV infected subjects The following outcome measures will be assessed RSV severity severe diseasehospitalized cases mild-moderate diseasenon-hospitalized cases virus load quantity and duration of RSV shedding as determined by quantitative RT-PCR T cell responses antibody acute serum IgG to RSV F and G proteins by EIA and and neutralization titer to RSV A2 or B1 virus depending upon the infecting strain local innate immune response maximum IL-6 or IL-8 or MIP-1 alpha levels in nasal secretions systemic innate immune response maximum number of NK cells in the peripheral blood and systemic inflammation maximum serum IL-6 or C reactive protein value
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None