NCT00609635

Brief Summary

This research study involves studying the genes that may affect how ill you become during respiratory infection with respiratory syncytial virus (RSV). RSV is a virus that often causes common colds. Cytokines are chemicals that are naturally made by your body. Cytokine levels are increased in some people when they have common colds or wheezing caused by respiratory syncytial virus (RSV). The purpose of this study is to study the genes that may control cytokine levels during infection with RSV in the elderly population.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2007

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, 2007

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 25, 2008

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 7, 2008

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
Last Updated

April 6, 2009

Status Verified

April 1, 2009

Enrollment Period

1.4 years

First QC Date

January 25, 2008

Last Update Submit

April 3, 2009

Conditions

Keywords

RespiratoryRSV-induced respiratory illness

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

inpatient or outpatient subjects with respiratory illnesses potentially caused by RSV

You may qualify if:

  • Subjects \> 65 years of age diagnosed with RSV-induced respiratory illness
  • Diagnosis (based upon ICD-9-CM codes) for pneumonia, upper respiratory illness, bronchitis, COPD, asthma, viral illness, or congestive heart failure (CHF)
  • Willing to sign informed consent.

You may not qualify if:

  • Not willing to sign informed consent.
  • Subjects less that 65 years of age
  • Subjects not diagnosed with a respiratory illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

A buccal brushing (cells collected from the inside of the cheek) will be collected and stored for DNA analysis.

MeSH Terms

Conditions

Respiratory Syncytial Virus Infections

Condition Hierarchy (Ancestors)

Pneumovirus InfectionsParamyxoviridae InfectionsMononegavirales InfectionsRNA Virus InfectionsVirus DiseasesInfections

Study Officials

  • Ritu Pabby, MD

    West Penn Allegheny Health System

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 25, 2008

First Posted

February 7, 2008

Study Start

November 1, 2007

Primary Completion

April 1, 2009

Study Completion

April 1, 2009

Last Updated

April 6, 2009

Record last verified: 2009-04

Locations