Respiratory Syncytial Virus InfectionsNCT00609635
Association Between Cytokines and Severity of Respiratory Syncytial Virus (RSV)-Induced Illness in the Elderly
An observational study of Respiratory Syncytial Virus Infections, run by West Penn Allegheny Health System at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Respiratory Syncytial Virus Infections
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2007to Apr 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: inpatient or outpatient subjects with respiratory illnesses potentially caused by RSV
Who may be able to join
- 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.
Who cannot join
- Not willing to sign informed consent.
- Subjects less that 65 years of age
- Subjects not diagnosed with a respiratory illness
Trial locations and contacts
1 site in 1 country.
United States1 site
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
About this study
Official title: The Association Between Cytokine Genotype Polymorphisms and Severity of RSV-Induced Illness in the Elderly
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.
- Conditions
- Respiratory Syncytial Virus Infections
- Keywords
- Respiratory, RSV-induced respiratory illness
- Medical subject headings
- Respiratory Syncytial Virus Infections
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2008 (estimated)
- Study startNov 2007
- Primary completionApr 2009
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Syncytial Virus InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West Penn Allegheny Health System
- Sponsor type
- University, hospital or other
- Collaborators
- American Academy of Allergy, Asthma, and Immunology
- Investigators
- Ritu Pabby, MD, Principal investigator, West Penn Allegheny Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00609635
- Sponsor's protocol ID
- Adult RSV RC# 4212
- Status last verified
- Apr 2009
- First submitted
- 25 Jan 2008
- Last updated
- 6 Apr 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Association Between Cytokine Genotype Polymorphisms and Severity of RSV-Induced Illness in the Elderly
- ClinicalTrials.gov ID
- NCT00609635
- Acronym / sponsor ID
- Adult RSV RC# 4212
- Conditions
- Respiratory Syncytial Virus Infections
- Keywords
- Respiratory, RSV-induced respiratory illness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- West Penn Allegheny Health SystemUniversity, hospital or other
- Collaborators
- American Academy of Allergy, Asthma, and Immunology
- Study start
- Nov 2007
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 7 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- inpatient or outpatient subjects with respiratory illnesses potentially caused by RSV
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- Not willing to sign informed consent.
- Subjects less that 65 years of age
- Subjects not diagnosed with a respiratory illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ritu Pabby, MD principal investigator
West Penn Allegheny Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Syncytial Virus Infections, run by West Penn Allegheny Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2009.