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Impact of a Regional Antimicrobial Stewardship on the Length of Stay of Patients Admitted to Hospital With Pneumonia (RASPCAP)

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ClinicalTrials.gov Identifier: NCT02276092
Recruitment Status : Unknown
Verified October 2015 by Giulio DiDiodato, Royal Victoria Hospital, Canada.
Recruitment status was:  Enrolling by invitation
First Posted : October 27, 2014
Last Update Posted : October 16, 2015
Sponsor:
Information provided by (Responsible Party):
Giulio DiDiodato, Royal Victoria Hospital, Canada

Brief 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. The program will identify patients with pneumonia, review their charts and make recommendations to their attending physicians about antibiotic management.

Condition or disease Intervention/treatment
Pneumonia Other: antimicrobial stewardship

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.


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 60 Days
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
Study Start Date : April 2015
Estimated Primary Completion Date : March 2017
Estimated Study Completion Date : April 2017

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
intervention
exposure to antimicrobial stewardship intervention
Other: antimicrobial stewardship
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
Other Name: prospective audit and feedback

control
usual care with no exposure to antimicrobial stewardship



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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 ]
    Total days of antibiotics administered for the treatment of community-acquired pneumonia

  2. Mortality rate [ Time Frame: 30 day post-discharge from hospital ]
    Deaths that occur post-discharge from hospital up to 30 days post-discharge

  3. Readmission to hospital [ Time Frame: 30 day post-discharge from hospital ]
    Readmissions to hospital that occur post-discharge from hospital up to 30 days post-discharge



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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
Criteria

Inclusion Criteria:

  • Community-acquired pneumonia
  • Immunocompetent
  • Age > 18 years

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02276092


Locations
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Canada, Ontario
Royal Victoria Regional Health Centre
Barrie, Ontario, Canada, L4M6M2
Sponsors and Collaborators
Royal Victoria Hospital, Canada
Investigators
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Principal Investigator: Giulio DiDiodato, MD Physician

Additional Information:

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Responsible Party: Giulio DiDiodato, principal investigator, Royal Victoria Hospital, Canada
ClinicalTrials.gov Identifier: NCT02276092     History of Changes
Other Study ID Numbers: RASP2013
First Posted: October 27, 2014    Key Record Dates
Last Update Posted: October 16, 2015
Last Verified: October 2015

Keywords provided by Giulio DiDiodato, Royal Victoria Hospital, Canada:
Community-acquired pneumonia
Pragmatic study
Multi-center
Time-dependent bias
antimicrobial stewardship
prospective audit and feedback

Additional relevant MeSH terms:
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Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Anti-Infective Agents
Anti-Bacterial Agents