PneumoniaRASPCAPNCT02276092
Impact of a Regional Antimicrobial Stewardship on the Length of Stay of Patients Admitted to Hospital With Pneumonia
An observational study of Pneumonia, run by Royal Victoria Hospital, Canada at 1 site in Canada.
Trial summary
This study evaluates the effectiveness of an antimicrobial stewardship program to reduce the length of stay of patients admitted to hospital with a diagnosis of pneumonia. The antimicrobial stewardship program will be implemented in several hospitals in Ontario, Canada. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumonia
- What is being tested?
- antimicrobial stewardship
- How many people
- 1,400 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2015to Apr 2017
- How long will I take part?
- 60 Days
- 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: Adult patients over the age of 18 years admitted to a hospital ward with a diagnosis of community-acquired pneumonia as determined by the most responsible physician
Who may be able to join
- Community-acquired pneumonia
- Immunocompetent
- Age > 18 years
Who cannot join
- Admitted to an intensive care unit or high intensity unit
- Requiring invasive or non-invasive ventilation
- Life expectancy less than 3 months
- Hospitalization within the previous 3 months for at least 48 consecutive hours
- Immunocompromised defined as defined as having leukemia, lymphoma, HIV with CD4 count <=200, splenectomy or on cytotoxic chemotherapy
- Neutropenic [defined as a PMN count<=0.5x109 cells/L] from any cause
- Receiving immunosuppressants [defined as >=40 mg prednisone daily (or steroid equivalent) for >=2 weeks preceding hospitalization OR any other immunosuppressant used for systemic illness OR to prevent transplant rejection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of a Regional Antimicrobial Stewardship Program to Reduce the Length of Stay of Patients Admitted to Hospital With Community-acquired Pneumonia: a Pragmatic Multi-centre Clinical Study
This study evaluates the effectiveness of an antimicrobial stewardship program to reduce the length of stay of patients admitted to hospital with a diagnosis of pneumonia. The antimicrobial stewardship program will be implemented in several hospitals in Ontario, Canada. The program will identify patients with pneumonia, review their charts and make recommendations to their attending physicians about antibiotic management.
Read the detailed description
Antimicrobial stewardship is defined as any activity that promotes the appropriate selection, dosing, route and duration of antibiotic therapy. Antimicrobial stewardship programs usually include pharmacists and/or doctors with expertise in infection diseases management. Prospective chart review and physician feedback is a common intervention used by antimicrobial stewardship programs to improve antibiotic utilization and patient outcomes.
Pneumonia is the most common reason for antibiotic utilization in hospitals. Significant variation in antibiotic utilization for patients with pneumonia has been repeatedly demonstrated in published studies despite the existence of best-practice treatment guidelines. Treatment variation from these guidelines has been demonstrated to result in worse outcomes such as increased mortality. Antimicrobial stewardship programs can help reduce the treatment variation from guidelines.
Despite improvements in certain outcomes, antimicrobial stewardship programs have not demonstrated any impact on the length of stay of patients admitted to hospital with pneumonia. Part of this absence of evidence may be due to poor study design and failure to recruit sufficient patients. This study will include the implementation of an antimicrobial stewardship program across many hospitals and the study design and analysis will account for the design problems of the previous studies.
- Conditions
- Pneumonia
- Being tested
- antimicrobial stewardship
- Keywords
- Community-acquired pneumonia, Pragmatic study, Multi-center, Time-dependent bias, antimicrobial stewardship, prospective audit and feedback
- Medical subject headings
- Pneumonia, Community-Acquired Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
antimicrobial stewardshipOther
Also called prospective audit and feedback
A member of the antimicrobial stewardship program will prospectively review the patient's medical record and make recommendations to the most responsible physician in the care of that patient
| Study group | Role | What they receive |
|---|---|---|
| intervention | exposure to antimicrobial stewardship intervention Receives: Other: antimicrobial stewardship | |
| control | usual care with no exposure to antimicrobial stewardship |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of hospital stay
Time (measured in days) from date of admission to one of the following potential outcomes, discharge alive, censoring at 14 days post admission, death, admission to an intensive care unit, or transfer to another hospital
Measured: Days from time of admission to time of discharge from hospital to a maximum of 14 days from the date of admission (or time to censoring at 14 days from the date of admissionor competing event depending on which comes first)
Secondary outcomes (3)
Days of antibiotic therapy
Total days of antibiotics administered for the treatment of community-acquired pneumonia
Measured: Days of antibiotic therapy for the treatment of pneumonia measured from the first day of antibiotic administered to the final day of antibiotic administered upto a maximum of 80 days
Mortality rate
Deaths that occur post-discharge from hospital up to 30 days post-discharge
Measured: 30 day post-discharge from hospital
Readmission to hospital
Readmissions to hospital that occur post-discharge from hospital up to 30 days post-discharge
Measured: 30 day post-discharge from hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2014 (estimated)
- Study startApr 2015
- Primary completionMar 2017
- Study completionApr 2017
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
- Prospective
- Enrolment
- 1,400 participants (actual)
- Target duration
- 60 Days
Sponsor and investigators
- Lead sponsor
- Royal Victoria Hospital, Canada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giulio DiDiodato, Royal Victoria Hospital, Canada
- Investigators
- Giulio DiDiodato, MD, Principal investigator, Physician
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02276092
- Sponsor's protocol ID
- RASP2013
- Acronym
- RASPCAP
- Status last verified
- Jan 2020
- First submitted
- 22 Oct 2014
- Last updated
- 27 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Regional Antimicrobial Stewardship Program to Reduce the Length of Stay of Patients Admitted to Hospital With Community-acquired Pneumonia: a Pragmatic Multi-centre Clinical Study
- ClinicalTrials.gov ID
- NCT02276092
- Acronym / sponsor ID
- RASPCAP / RASP2013
- Conditions
- Pneumonia
- Keywords
- Community-acquired pneumonia, Pragmatic study, Multi-center, Time-dependent bias, antimicrobial stewardship, prospective audit and feedback
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,400 participants (actual)
- Lead sponsor
- Royal Victoria Hospital, CanadaUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Mar 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 27 Oct 2014 (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 evaluates the effectiveness of an antimicrobial stewardship program to reduce the length of stay of patients admitted to hospital with a diagnosis of pneumonia. The antimicrobial stewardship program will be implemented in several hospitals in Ontario, Canada. The program will identify patients with pneumonia, review their charts and make recommendations to their attending physicians about antibiotic management.
Detailed description
Antimicrobial stewardship is defined as any activity that promotes the appropriate selection, dosing, route and duration of antibiotic therapy. Antimicrobial stewardship programs usually include pharmacists and/or doctors with expertise in infection diseases management. Prospective chart review and physician feedback is a common intervention used by antimicrobial stewardship programs to improve antibiotic utilization and patient outcomes.
Pneumonia is the most common reason for antibiotic utilization in hospitals. Significant variation in antibiotic utilization for patients with pneumonia has been repeatedly demonstrated in published studies despite the existence of best-practice treatment guidelines. Treatment variation from these guidelines has been demonstrated to result in worse outcomes such as increased mortality. Antimicrobial stewardship programs can help reduce the treatment variation from guidelines.
Despite improvements in certain outcomes, antimicrobial stewardship programs have not demonstrated any impact on the length of stay of patients admitted to hospital with pneumonia. Part of this absence of evidence may be due to poor study design and failure to recruit sufficient patients. This study will include the implementation of an antimicrobial stewardship program across many hospitals and the study design and analysis will account for the design problems of the previous studies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 60 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention | – | Other: antimicrobial stewardshipexposure to antimicrobial stewardship intervention |
| control | – | –usual care with no exposure to antimicrobial stewardship |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients over the age of 18 years admitted to a hospital ward with a diagnosis of community-acquired pneumonia as determined by the most responsible physician
Key inclusion criteria (3 listed)
- Community-acquired pneumonia
- Immunocompetent
- Age > 18 years
Key exclusion criteria (7 listed)
- Admitted to an intensive care unit or high intensity unit
- Requiring invasive or non-invasive ventilation
- Life expectancy less than 3 months
- Hospitalization within the previous 3 months for at least 48 consecutive hours
- Immunocompromised defined as defined as having leukemia, lymphoma, HIV with CD4 count <=200, splenectomy or on cytotoxic chemotherapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| antimicrobial stewardshipAlso: prospective audit and feedbackA member of the antimicrobial stewardship program will prospectively review the patient's medical record and make recommendations to the most responsible physician in the care of that patient | Other | intervention |
Primary outcome
Length of hospital stay
Time frame: Days from time of admission to time of discharge from hospital to a maximum of 14 days from the date of admission (or time to censoring at 14 days from the date of admissionor competing event depending on which comes first)
Time (measured in days) from date of admission to one of the following potential outcomes, discharge alive, censoring at 14 days post admission, death, admission to an intensive care unit, or transfer to another hospital
3 secondary outcomes
Days of antibiotic therapy
Time frame: Days of antibiotic therapy for the treatment of pneumonia measured from the first day of antibiotic administered to the final day of antibiotic administered upto a maximum of 80 days
Mortality rate
Time frame: 30 day post-discharge from hospital
Readmission to hospital
Time frame: 30 day post-discharge from hospital
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 27 Jan 2020.
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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.
Giulio DiDiodato, MD principal investigator
Physician
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 Royal Victoria Hospital, Canada at 1 site in Canada.
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 7 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 27 Jan 2020. 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 Canada. 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?
Length of hospital stay (time frame: Days from time of admission to time of discharge from hospital to a maximum of 14 days from the date of admission (or time to censoring at 14 days from the date of admissionor competing event depending on which comes first)). 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 27 Jan 2020.