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

Pneumonia Clinical Trial

— RASPCAP  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02276092
• Other study ID #: RASP2013
• Status: Completed
• Start date: April 2015
• Est. completion date: April 2017

Study information

• Verified date: January 2020
• Source: Royal Victoria Hospital, Canada
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1400
• Est. completion date: April 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pneumonia

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

Locations

Country	Name	City	State
Canada	Royal Victoria Regional Health Centre	Barrie	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Royal Victoria Hospital, Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	Days of antibiotic therapy	Total days of antibiotics administered for the treatment of community-acquired pneumonia	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
Secondary	Mortality rate	Deaths that occur post-discharge from hospital up to 30 days post-discharge	30 day post-discharge from hospital
Secondary	Readmission to hospital	Readmissions to hospital that occur post-discharge from hospital up to 30 days post-discharge	30 day post-discharge from hospital