Community Acquired PneumoniaNCT01963000
Standardized Emergency Care for Community Acquired Pneumonia (CAP)
An observational study of Community Acquired Pneumonia and Pneumonia, run by Klinikum Nürnberg at 1 site in Germany.
Trial summary
Community acquired pneumonia (CAP) is associated with a high in-hospital mortality. Standardization of diagnostics and adherence to sepsis bundles in the emergency department (ED) are associated with reduced mortality in patients with sepsis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Community Acquired Pneumonia, Pneumonia, Infection
- How many people
- 2,819 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2007to Dec 2012
- 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: Emergency department patients
Who may be able to join
- all patients with community acquired pneumonia
Who cannot join
- exacerbation of chronic obstructive pulmonary disease
- malignancy
- immunosuppression
- neutropenia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reduction of Mortality in Community-Acquired Pneumonia After Implementing Standardized Care Bundles in the Emergency Department
Community acquired pneumonia (CAP) is associated with a high in-hospital mortality. Standardization of diagnostics and adherence to sepsis bundles in the emergency department (ED) are associated with reduced mortality in patients with sepsis. Investigators examined whether the introduction of standardized care bundles and check lists in the ED are associated with a reduced mortality rate in patients hospitalized for CAP.
This is an observational trial. The investigators retrospectively analyzed performance indicators of 2819 consecutive patients with CAP admitted to the Nuremberg Hospital, Germany, from 2008 to 2009. At the turn of the year, implementation of CAP care bundles took place including interprofessional education, checklists and institutionalized feedback. Primary endpoint was in-hospital mortality of CAP patients. After the implementation of CAP care bundles in the ED, mortality of affected patients was significantly lower in 2009 compared to 2008. This study should demonstrate that the implementation of a standardized CAP care bundle in the ED is associated with a risk reduction in affected patients. Standardization of diagnostic and therapeutic processes in the ED therefore improves the outcome of patients hospitalized for CAP.
- Conditions
- Community Acquired Pneumonia, Pneumonia, Infection
- Keywords
- Community Acquired Pneumonia, Emergency Department, Standardized Care, Reduced Mortality, CRB-65 Risk Classes, Antibiotic Therapy
- Medical subject headings
- Community-Acquired Pneumonia, Pneumonia, Infections, Emergencies
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 |
|---|---|---|
| CAP | A patient with CAP was identified by encoding pneumonia without severe immunosuppression (HIV infection, solid organ or bone marrow/stem cell transplants, severe neutropenia) as the main diagnosis (ICD 10 GM) of hospital admission. |
What is being measured
The primary outcome is the main question the study is designed to answer.
mortality of CAP patients
Measured: up to 14days
Secondary outcomes (1)
mortality up to 14days in subgroups
Mortality of patients upt to 14day is determined in subgroups (different age groups, sub-groups of CRB-risk classes)
CRB-65: C mental confusion; R respiratory rate ≥30/min; B systolic blood pressure <90 mm Hg; 65, age ≥65 years
Measured: up to 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2013 (estimated)
- Study startJan 2007
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Community Acquired 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
- 2,819 participants (actual)
Sponsor and investigators
- Lead sponsor
- Klinikum Nürnberg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Michael Christ, Klinikum Nürnberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01963000
- Sponsor's protocol ID
- CAP01ED
- Status last verified
- Oct 2013
- First submitted
- 10 Oct 2013
- Last updated
- 16 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduction of Mortality in Community-Acquired Pneumonia After Implementing Standardized Care Bundles in the Emergency Department
- ClinicalTrials.gov ID
- NCT01963000
- Acronym / sponsor ID
- CAP01ED
- Conditions
- Community Acquired Pneumonia, Pneumonia, Infection
- Keywords
- Community Acquired Pneumonia, Emergency Department, Standardized Care, Reduced Mortality, CRB-65 Risk Classes, Antibiotic Therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,819 participants (actual)
- Lead sponsor
- Klinikum NürnbergUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 16 Oct 2013 (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 associated with a high in-hospital mortality. Standardization of diagnostics and adherence to sepsis bundles in the emergency department (ED) are associated with reduced mortality in patients with sepsis. Investigators examined whether the introduction of standardized care bundles and check lists in the ED are associated with a reduced mortality rate in patients hospitalized for CAP.
This is an observational trial. The investigators retrospectively analyzed performance indicators of 2819 consecutive patients with CAP admitted to the Nuremberg Hospital, Germany, from 2008 to 2009. At the turn of the year, implementation of CAP care bundles took place including interprofessional education, checklists and institutionalized feedback. Primary endpoint was in-hospital mortality of CAP patients. After the implementation of CAP care bundles in the ED, mortality of affected patients was significantly lower in 2009 compared to 2008. This study should demonstrate that the implementation of a standardized CAP care bundle in the ED is associated with a risk reduction in affected patients. Standardization of diagnostic and therapeutic processes in the ED therefore improves the outcome of patients hospitalized for CAP.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CAP | – | –A patient with CAP was identified by encoding pneumonia without severe immunosuppression (HIV infection, solid organ or bone marrow/stem cell transplants, severe neutropenia) as the main diagnosis (ICD 10 GM) of hospital admission. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Emergency department patients
Key inclusion criteria (1 listed)
- all patients with community acquired pneumonia
Key exclusion criteria (4 listed)
- exacerbation of chronic obstructive pulmonary disease
- malignancy
- immunosuppression
- neutropenia
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
mortality of CAP patients
Time frame: up to 14days
1 secondary outcome
mortality up to 14days in subgroups
Time frame: up to 14 days
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 16 Oct 2013.
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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 Community Acquired Pneumonia and Pneumonia, run by Klinikum Nürnberg at 1 site in Germany.
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 1 inclusion and 4 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 16 Oct 2013. 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 Germany. 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.
What does the primary outcome measure?
mortality of CAP patients (time frame: up to 14days). It is what the study was designed to measure, not a finding.
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 16 Oct 2013.