Clinical trial NCT02276092: Impact of a Regional Antimicrobial Stewardship on the Length of Stay of Patients Admitted to Hospital With Pneumonia
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pneumonia
Keywords: Community-acquired pneumonia
Pragmatic study
Multi-center
Time-dependent bias
antimicrobial stewardship
prospective audit and feedback
Lead sponsor: Royal Victoria Hospital, Canada
Sponsor class: OTHER
First posted: 2014-10-27
Enrollment: 1400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

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.

Eligibility 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

Primary outcomes:
measure: Length of hospital stay
timeFrame: 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:
measure: Days of antibiotic therapy
timeFrame: 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
measure: Mortality rate
timeFrame: 30 day post-discharge from hospital
measure: Readmission to hospital
timeFrame: 30 day post-discharge from hospital
Other outcomes:
Locations:
city: Barrie
country: Canada
facility: Royal Victoria Regional Health Centre
state: Ontario
Study officials:
affiliation: Physician
name: Giulio DiDiodato, MD
role: PRINCIPAL_INVESTIGATOR
References: