PneumoniaNCT00304395
Pulmonary Infections Masquerading as Community-Acquired Pneumonia
An observational study of Pneumonia, run by Michael E. DeBakey VA Medical Center at 1 site in United States.
Trial summary
The purpose of this research is to identify cases from patients who have been referred for consultation to the Infectious Disease Section at the VAMC, Houston, and to compare them with other cases of CAP in order to determine whether there are features that might enable non-CAP cases to be distinguished from CAP. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Pneumonia
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2004to Jan 2007
- 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 to 64 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients with Pulmonary infections.
Who may be able to join
- subjects who were seen in calendar year 2004 because they were thought to have CAP, but who, upon further evaluation, plainly did not, and consultation was sought.
- case control is diagnosis of CAP with verification by all or nearly all of the following features: presence of cough, increased sputum, fever, leukocytosis and a distinct new pulmonary infiltrate.
Who cannot join
- among the case controls, if the diagnosis of CAP was made despite the absence of the cardinal features of CAP, as cited above, the investigators will not include the case.
Trial locations and contacts
1 site in 1 country.
United States1 site
Michael E. DeBakey Veterans Affairs Medical Center
Houston, Texas, 77030
About this study
The purpose of this research is to identify cases from patients who have been referred for consultation to the Infectious Disease Section at the VAMC, Houston, and to compare them with other cases of CAP in order to determine whether there are features that might enable non-CAP cases to be distinguished from CAP.
Read the detailed description
Guidelines to treat community acquired pneumonia (CAP) have been developed and widely promulgated by important professional societies in the past 10 years. The impetus to do so came from the observation that practicing physicians were using a wide array of approaches to this common infection, many of which were substandard.
The Infectious Disease Society of America (IDSA) and American Thoracic Society (ATS) have been leaders in this field, publishing recommendations separately between 1993 and 2003. The PI served on the IDSA committee and coauthored the publication in 2000 and the update in 2003. In 2004, a decision was made by the two professional societies to merge the committees and make a single joint set of recommendations; the PI is a member of that joint committee and a new document is being prepared for publication.
The PI has observed a tendency to apply these guidelines to cases that might masquerade as CAP but are actually attributable to other conditions, such as lung cancer, tuberculosis and histoplasmosis. Further, the recommendations do not adequately cover pneumonia due to Staphylococcus aureus.
The purpose of the research is to identify cases from the consult records of the Infectious Disease Section at the VAMC, Houston, and to compare them with other cases of CAP in order to determine whether there are features that might enable non-CAP cases to be distinguished from CAP.
- Conditions
- Pneumonia
- Keywords
- Community Acquired Pneumonia, CAP
- Medical subject headings
- Pneumonia, Community-Acquired Pneumonia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2006 (estimated)
- Study startJan 2004
- Primary completionJan 2007
- Study completionJan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PneumoniaStudies 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
- Retrospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michael E. DeBakey VA Medical Center
- Sponsor type
- US federal agency
- Collaborators
- Baylor College of Medicine
- Responsible party
- Principal investigator, Daniel M. Musher MD, Michael E. DeBakey VA Medical Center
- Investigators
- Daniel M Musher, M.D., Principal investigator, Baylor College of Medicine, Houston VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00304395
- Sponsor's protocol ID
- H-17555
- Status last verified
- Oct 2021
- First submitted
- 16 Mar 2006
- Last updated
- 29 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulmonary Infections Masquerading as Community-Acquired Pneumonia
- ClinicalTrials.gov ID
- NCT00304395
- Acronym / sponsor ID
- H-17555
- Conditions
- Pneumonia
- Keywords
- Community Acquired Pneumonia, CAP
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Michael E. DeBakey VA Medical CenterUS federal agency
- Collaborators
- Baylor College of Medicine
- Study start
- Jan 2004
- Primary completion
- Jan 2007 (actual)
- Study completion
- Jan 2007 (actual)
- First posted
- 17 Mar 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.
The purpose of this research is to identify cases from patients who have been referred for consultation to the Infectious Disease Section at the VAMC, Houston, and to compare them with other cases of CAP in order to determine whether there are features that might enable non-CAP cases to be distinguished from CAP.
Detailed description
Guidelines to treat community acquired pneumonia (CAP) have been developed and widely promulgated by important professional societies in the past 10 years. The impetus to do so came from the observation that practicing physicians were using a wide array of approaches to this common infection, many of which were substandard.
The Infectious Disease Society of America (IDSA) and American Thoracic Society (ATS) have been leaders in this field, publishing recommendations separately between 1993 and 2003. The PI served on the IDSA committee and coauthored the publication in 2000 and the update in 2003. In 2004, a decision was made by the two professional societies to merge the committees and make a single joint set of recommendations; the PI is a member of that joint committee and a new document is being prepared for publication.
The PI has observed a tendency to apply these guidelines to cases that might masquerade as CAP but are actually attributable to other conditions, such as lung cancer, tuberculosis and histoplasmosis. Further, the recommendations do not adequately cover pneumonia due to Staphylococcus aureus.
The purpose of the research is to identify cases from the consult records of the Infectious Disease Section at the VAMC, Houston, and to compare them with other cases of CAP in order to determine whether there are features that might enable non-CAP cases to be distinguished from CAP.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients with Pulmonary infections.
Key inclusion criteria (2 listed)
- subjects who were seen in calendar year 2004 because they were thought to have CAP, but who, upon further evaluation, plainly did not, and consultation was sought.
- case control is diagnosis of CAP with verification by all or nearly all of the following features: presence of cough, increased sputum, fever, leukocytosis and a distinct new pulmonary infiltrate.
Key exclusion criteria (1 listed)
- among the case controls, if the diagnosis of CAP was made despite the absence of the cardinal features of CAP, as cited above, the investigators will not include the case.
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 29 Oct 2021.
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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.
Daniel M Musher, M.D. principal investigator
Baylor College of Medicine, Houston VA Medical Center
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 Pneumonia, run by Michael E. DeBakey VA Medical Center 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 1 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 29 Oct 2021. 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 29 Oct 2021.