Improving Antibiotic Use in Hospitalized Patients With Pneumonia

NCT02264756 | Completed

• 1 other identifier: CAPASP2013
• Study Type: observational
• Target: 763
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to determine whether an antimicrobial stewardship program can decrease the length of hospital stay for patients with pneumonia. The antimicrobial stewardship program is run by a pharmacist and doctor with extensive training in managing infectious diseases. These two health care professionals are responsible for reviewing the records of patients admitted to hospital with pneumonia, and then making specific recommendations to the patient's attending physician about how to manage antibiotic treatment. These recommendations might include discontinuing the antibiotic, or changing the way antibiotics are delivered from intravenous form to pill form, among many other potential options. The attending physician considers whether these recommendations should be followed or rejected. The study has a control group of patients who are not reviewed by the antimicrobial stewardship team, and their length of hospital stay will be compared to the reviewed group of patients. Any differences between these two groups will be assumed to be due to the impact of the antimicrobial stewardship program. So far, no previous study has been able to demonstrate that an antimicrobial stewardship program can reduce the length of stay of patients admitted to hospital with pneumonia. This study has some important differences from previous studies that may make its conclusions more accurately reflect the true impact of antimicrobial stewardship programs. The most important difference is how the timing of the review is modelled in the analysis of the study results. Because the timing of the review varies between patients, with some patients being reviewed at earlier and some at later times, this subtle difference, if not accounted for in the analysis, can mask a true positive effect of the program on length of stay. The investigators study will account for this variation.

Conditions

Pneumonia

Keywords

Community-acquired pneumonia; Pragmatic clinical trial; Antimicrobial stewardship; length of stay; stepped-wedge design; time-dependent bias

Outcome Measures

Primary Outcomes (1)

• Hospital length of stay

  Time to discharge or censoring event

  Patients will be followed for 14 days from date of admission and if not discharged will be administratively censored

Secondary Outcomes (4)

• 30-day post-discharge mortality rate

  30 calendar days after hospital discharge

• 30-day post-discharge readmission rate

  30 calendar days after hospital discharge

• Days of antimicrobial therapy

  Total days of antimicrobial therapy for each antibiotic calculated from date of first administration on admission to hospital to date of discontinuation (or to date of censoring, whichever comes first) upto a maximum of 30 days post-discharge follow-up

• Duration of antimicrobial therapy

  Total duration of all antibiotics administered starting from date of administration of first antibiotic to date of discontinuation of last antibiotic (or to date of censoring, whichever comes first) upto a maximum of 30 days post-discharge from hospital

Study Arms (1)

Ward CAP

Adult immune-competent patients admitted to ward with clinical diagnosis of community-acquired pneumonia will be potentially exposed to ASP review

Other: ASP review

Interventions

ASP review OTHER

patients admitted to hospital with a diagnosis of community-acquired pneumonia will be reviewed by team members of antimicrobial stewardship program and subsequently feedback to attending physicians will be offered in the form of recommendations for antibiotic management

Also known as: prospective chart audit and attending physician feedback

Ward CAP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult immune-competent hospital inpatients admitted to a ward at the Royal Victoria Regional Health Centre, Barrie, Ontario, Canada

You may qualify if:

• have a positive Febrile Respiratory Illness (FRI) screen on admission to hospital (http://www.health.gov.on.ca/fr/public/programs/emu/sars/reports/dir\_122303\_acute\_care\_nonoutbreak.pdf)
• diagnosed with pneumonia by the admitting physician (Acute exacerbations of chronic obstructive lung disease are considered within the definition of pneumonia for the purposes of this study as they are commonly treated with the same antimicrobial regimens as patients with pneumonia)
• admitted to a medical ward

You may not qualify if:

• hospitalized for ≥ 48 consecutive hours in the preceding 3 months
• receiving immunosuppressants \[defined as ≥ 40 mg prednisone daily (or steroid equivalent) for ≥ 2 weeks preceding hospitalization OR any other immunosuppressant used for systemic illness OR to prevent transplant rejection\]
• neutropenic \[defined as a polymorphonuclear count ≤ 0.5 x 109 cells/L\] from any cause
• immunocompromised \[defined as having leukemia, lymphoma, HIV with CD4 cell count ≤ 200, splenectomy or on cytotoxic chemotherapy\]
• admitted to high acuity units such as intensive care units
• require mechanical ventilation, either non-invasive or invasive
• have a life expectancy of ≤ 3 months (palliative)

Sponsors & Collaborators

• Giulio DiDiodato: lead

Study Sites (1)

Royal Victoria Regional Health Centre

Barrie, Ontario, L0L2L0, Canada

Location

Related Publications (1)

• DiDiodato G, McArthur L, Beyene J, Smieja M, Thabane L. Can an antimicrobial stewardship program reduce length of stay of immune-competent adult patients admitted to hospital with diagnosis of community-acquired pneumonia? Study protocol for pragmatic controlled non-randomized clinical study. Trials. 2015 Aug 14;16:355. doi: 10.1186/s13063-015-0871-2.

  PMID: 26272324 DERIVED

MeSH Terms

Conditions

Pneumonia; Community-Acquired Pneumonia

Condition Hierarchy (Ancestors)

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

Study Officials

• Giulio DiDiodato, MD

  Royal Victoria Regional Health Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 4 Weeks
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Medical Lead, Antimicrobial Stewardship Program

Study Record Dates

• First Submitted: September 30, 2014
• First Posted: October 15, 2014
• Study Start: April 1, 2013
• Primary Completion: March 1, 2015
• Study Completion: April 1, 2015
• Last Updated: January 27, 2020

Record last verified: 2020-01

Locations

CA (1)