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Completed

NCT Number: NCT02276092

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

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.

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Key information

Conditions

Pneumonia Community-Acquired Infections Community-Acquired Pneumonia Infections Lung Diseases Respiratory Tract Diseases Respiratory Tract Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Royal Victoria Regional Health Centre

Barrie, Ontario, L4M6M2, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

antimicrobial stewardship

Other

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 names: prospective audit and feedback

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Royal Victoria Hospital, Canada

Other

Registry information

Official study 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

Acronym: RASPCAP

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Oct 27, 2014
Registry last updated
Jan 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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