NCT02276092

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 22, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 27, 2014

Completed
5 months until next milestone

Study Start

First participant enrolled

April 1, 2015

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

January 27, 2020

Status Verified

January 1, 2020

Enrollment Period

1.9 years

First QC Date

October 22, 2014

Last Update Submit

January 24, 2020

Conditions

Pneumonia

Keywords

Community-acquired pneumoniaPragmatic studyMulti-centerTime-dependent biasantimicrobial stewardshipprospective audit and feedback

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Days of antibiotic therapy

    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

    30 day post-discharge from hospital

  • Readmission to hospital

    30 day post-discharge from hospital

Study Arms (2)

intervention

exposure to antimicrobial stewardship intervention

Other: antimicrobial stewardship

control

usual care with no exposure to antimicrobial stewardship

Interventions

antimicrobial stewardshipOTHER

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

Also known as: prospective audit and feedback
intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Victoria Regional Health Centre

Barrie, Ontario, L4M6M2, Canada

Location

MeSH Terms

Conditions

PneumoniaCommunity-Acquired Pneumonia

Interventions

Antimicrobial Stewardship

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsLung DiseasesRespiratory Tract DiseasesCommunity-Acquired Infections

Intervention Hierarchy (Ancestors)

Drug Utilization ReviewDrug UtilizationPharmacy AdministrationOrganization and AdministrationHealth Services AdministrationUtilization ReviewQuality of Health CareQuality Assurance, Health CareHealth Care Quality, Access, and Evaluation

Study Officials

  • Giulio DiDiodato, MD

    Physician

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
60 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

October 22, 2014

First Posted

October 27, 2014

Study Start

April 1, 2015

Primary Completion

March 1, 2017

Study Completion

April 1, 2017

Last Updated

January 27, 2020

Record last verified: 2020-01

Locations

CA(1)