CompletedNot Applicable

Improving Antibiotic Use in Hospitalized Patients With Pneumonia

Canada763 participantsStarted 2013-04

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * 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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Hospital length of stay

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

Trial details

NCT IDNCT02264756

SponsorGiulio DiDiodato

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2015-03

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