Respiratory Infections, AcuteNCT00170495
Acute Viral Respiratory Infections in Elderly
An observational study of Respiratory Infections, Acute, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Respiratory Infections, Acute
- How many people
- 3,000 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2004to Jul 2006
- 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: male and female adults age 65 and older with acute respiratory illness (common colds, flu, bronchitis, pneumonia)
Who may be able to join
- 65 years of age or older
- Presentation to the geriatric clinic with an acute respiratory illness of less than 7 days' duration.
Who cannot join
- Presentation to the geriatric clinic with a history of a respiratory illness of greater than 7 days' duration.
- Physician/physician assistant judgment that the respiratory complaints do not represent an acute infection.
- Patient declines to permit specimen collection.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Etiology and Impact of Acute Viral Respiratory Infections in Ambulatory Elderly Populations
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.
Read the detailed 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.
- Conditions
- Respiratory Infections, Acute
- Keywords
- respiratory illness, influenza, bronchitis, pneumonia, cold
- Medical subject headings
- Respiratory Tract Infections, Influenza, Human, Bronchitis, Pneumonia, Common Cold
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| observation | male and female adults age 65 and older with acute respiratory illness (common colds, flu, bronchitis, pneumonia) |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startSep 2004
- Primary completionJul 2006
- Study completionJul 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Infections, AcuteStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- 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
- 3,000 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00170495
- Sponsor's protocol ID
- 04-049
- Other IDs
- H-14802
- Status last verified
- Sep 2008
- First submitted
- 12 Sep 2005
- Last updated
- 27 Aug 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Etiology and Impact of Acute Viral Respiratory Infections in Ambulatory Elderly Populations
- ClinicalTrials.gov ID
- NCT00170495
- Acronym / sponsor ID
- 04-049
- Conditions
- Respiratory Infections, Acute
- Keywords
- respiratory illness, influenza, bronchitis, pneumonia, cold
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 3,000 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- Sep 2004
- Primary completion
- Jul 2006 (actual)
- Study completion
- Jul 2006 (actual)
- First posted
- 15 Sep 2005 (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 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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| observation | – | –male and female adults age 65 and older with acute respiratory illness (common colds, flu, bronchitis, pneumonia) |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- male and female adults age 65 and older with acute respiratory illness (common colds, flu, bronchitis, pneumonia)
Key inclusion criteria (2 listed)
- 65 years of age or older
- Presentation to the geriatric clinic with an acute respiratory illness of less than 7 days' duration.
Key exclusion criteria (3 listed)
- Presentation to the geriatric clinic with a history of a respiratory illness of greater than 7 days' duration.
- Physician/physician assistant judgment that the respiratory complaints do not represent an acute infection.
- Patient declines to permit specimen collection.
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 was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2010.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Infections, Acute, run by National Institute of Allergy and Infectious Diseases (NIAID) 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 2 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: stopped early, as of the sponsor's last update on 27 Aug 2010. 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 was stopped early. Results are not available in the source record.
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 27 Aug 2010.