CoughNCT00275691
Evaluation of Respiratory Specimens for Bacterial and Viral Pathogens by Real-Time PCR
An observational study of Cough and Fever, run by Mayo Clinic at 1 site in United States.
Trial summary
Community acquired pneumonia(CAP) is a common cause of morbidity and mortality. The diagnosis of CAP from the microbiology perspective has been challenging. Recent reports suggest the utility of real-time PCR for rapid and accurate diagnoses of these pathogens. Read more about this study
- Who is it for?
- Ages 18 years and older
- How many people
- 867 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2005to Jun 2008
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Greater than 18 years of age. Cough present greater than one day and a history of fever and chills or documented fever in the Emergency Department
Greater than 18 years of age. Cough present greater than one day and a history of fever and chills or documented fever in the Emergency Department
Trial locations and contacts
1 site in 1 country.
About this study
Community acquired pneumonia(CAP) is a common cause of morbidity and mortality. The diagnosis of CAP from the microbiology perspective has been challenging. Recent reports suggest the utility of real-time PCR for rapid and accurate diagnoses of these pathogens. Real-Time PCR tests, using the LightCycler instrument, will be performed on excess or additional specimens after extraction of nucleic acid.
Read the detailed description
Excess patient specimens normally collected for routine microbiologic testing for CAP and in some cases additional specimens (i.e.,blood, urine, throat swab) will be evaluated using real-time PCR tests developed in our laboratory. Specimens will be performed on patients suspect for CAP. Test will be directed at variety of pathogens including but not limited to M.pneumoniae, C. pneumoniae, Legionella pneumophila, Streptococcus pneumoniae, B. pertussis, influenza viruses, adenovirus, and metapneumovirus. The ultimate goal is to have a panel of highly accurate and rapid (same day) tests that can be orderable and performed in short period time for CAP cases.
Real-Time PCR tests, using the LightCycler instrument, will be performed on excess or additional specimens after extraction of nucleic acid. Real-time PCR tests, using the LightCycler instrument, will be performed on excess or additional specimens after extraction nucleic acid. These tests will include the organisms listed above. As nucleic acid extracts will be archived, other pathogens can be tested in the future should we develop additional real-time PCR tests. All results obtained by real-time PCR will be compared to results for conventional testing as listed above. Sensitivity, specificity and predictive values will be calculated. In cases where discordant results occur, additional PCR testing and or medical history review will be conducted.
- Medical subject headings
- Cough, Fever
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2006 (estimated)
- Study startOct 2005
- Primary completionJun 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CoughStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Time perspective
- Prospective
- Enrolment
- 867 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Investigators
- Franklin R. Cockerill, III, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00275691
- Sponsor's protocol ID
- 2354-02
- Status last verified
- Jan 2010
- First submitted
- 10 Jan 2006
- Last updated
- 18 Jan 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Respiratory Specimens for Bacterial and Viral Pathogens by Real-Time PCR
- ClinicalTrials.gov ID
- NCT00275691
- Acronym / sponsor ID
- 2354-02
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 867 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Oct 2005
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 12 Jan 2006 (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.
Community acquired pneumonia(CAP) is a common cause of morbidity and mortality. The diagnosis of CAP from the microbiology perspective has been challenging. Recent reports suggest the utility of real-time PCR for rapid and accurate diagnoses of these pathogens. Real-Time PCR tests, using the LightCycler instrument, will be performed on excess or additional specimens after extraction of nucleic acid.
Detailed description
Excess patient specimens normally collected for routine microbiologic testing for CAP and in some cases additional specimens (i.e.,blood, urine, throat swab) will be evaluated using real-time PCR tests developed in our laboratory. Specimens will be performed on patients suspect for CAP. Test will be directed at variety of pathogens including but not limited to M.pneumoniae, C. pneumoniae, Legionella pneumophila, Streptococcus pneumoniae, B. pertussis, influenza viruses, adenovirus, and metapneumovirus. The ultimate goal is to have a panel of highly accurate and rapid (same day) tests that can be orderable and performed in short period time for CAP cases.
Real-Time PCR tests, using the LightCycler instrument, will be performed on excess or additional specimens after extraction of nucleic acid. Real-time PCR tests, using the LightCycler instrument, will be performed on excess or additional specimens after extraction nucleic acid. These tests will include the organisms listed above. As nucleic acid extracts will be archived, other pathogens can be tested in the future should we develop additional real-time PCR tests. All results obtained by real-time PCR will be compared to results for conventional testing as listed above. Sensitivity, specificity and predictive values will be calculated. In cases where discordant results occur, additional PCR testing and or medical history review will be conducted.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Greater than 18 years of age. Cough present greater than one day and a history of fever and chills or documented fever in the Emergency Department
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 18 Jan 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.
Franklin R. Cockerill, III, M.D. principal investigator
Mayo Clinic
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 Cough and Fever, run by Mayo Clinic 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?
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 18 Jan 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 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 18 Jan 2010.