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Antibiotic Stewardship for Pneumonia
N/A
Waitlist Available
Led By Michael Klompas, MD
Research Sponsored by Brigham and Women's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
All patients admitted to Brigham and Women's and BWH Faulkner Hospitals and prescribed antibiotics with a stated indication of pneumonia who have a median respiratory rate of ≤20 and oxygen saturation of ≥95% without supplemental oxygen sustained for at least 24 hours.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up duration of hospitalization, up to 90 days
Awards & highlights
Study Summary
This trial is testing whether an electronic alert or pharmacist outreach can help decrease unnecessary antibiotics prescribed to hospitalized patients for possible pneumonia.
Who is the study for?
This trial is for hospitalized patients at Brigham and Women's and BWH Faulkner Hospitals who are prescribed antibiotics for pneumonia but have normal breathing rates (≤20 breaths/min) and oxygen levels (≥95% without extra oxygen) for over 24 hours. It excludes those with cystic fibrosis, in intensive care, on immunosuppressants, under 18, pregnant, or with certain serious infections.Check my eligibility
What is being tested?
The study aims to reduce unnecessary antibiotic use in possible pneumonia cases by comparing usual care with two strategies: an electronic alert system and direct pharmacist outreach. Patients will be randomly assigned to one of these three approaches.See study design
What are the potential side effects?
Since the interventions involve messaging rather than medications, there are no direct side effects from drugs. However, if reducing antibiotics is not appropriate for some patients, it could potentially lead to inadequate treatment of infections.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have pneumonia, treated at Brigham and Women's or BWH Faulkner, breathe normally, and don't need extra oxygen.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ duration of hospitalization, up to 90 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~duration of hospitalization, up to 90 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Duration of antibiotics prescribed for pneumonia
Secondary outcome measures
Acute kidney injury (maximum creatinine in the 14-days post-randomization)
Antibiotic-free days in the 30-days post-randomization
C. difficile infections in the 30-days post-randomization
+5 moreTrial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: PharmacistExperimental Treatment1 Intervention
Pharmacists will contact the treating teams of eligible patients to note that the patient's respiratory rate and oxygenation are within the normal range and will advise stopping antibiotics prescribed for possible pneumonia.
Group II: Electronic alertExperimental Treatment1 Intervention
An electronic alert will be displayed within the electronic medical record of eligible patients that notes that the patient's respiratory rate and oxygenation are within the normal range and will advise stopping antibiotics prescribed for possible pneumonia
Group III: Usual careActive Control1 Intervention
Clinical teams will decide on antibiotic duration for patients with possible pneumonia without external prompting
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Who is running the clinical trial?
Brigham and Women's HospitalLead Sponsor
1,611 Previous Clinical Trials
11,468,519 Total Patients Enrolled
7 Trials studying Pneumonia
26,727 Patients Enrolled for Pneumonia
Centers for Disease Control and PreventionFED
875 Previous Clinical Trials
22,475,402 Total Patients Enrolled
14 Trials studying Pneumonia
13,568 Patients Enrolled for Pneumonia
Michael Klompas, MDPrincipal InvestigatorBrigham and Women's Hospital
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have pneumonia, treated at Brigham and Women's or BWH Faulkner, breathe normally, and don't need extra oxygen.I have cystic fibrosis or bronchiectasis.I am currently in an intensive care unit.I am taking medication that weakens my immune system.I am under 18 years old.I am currently receiving care from transplant or cancer specialists.You have a positive blood culture, except if it is due to common skin contaminants.
Research Study Groups:
This trial has the following groups:- Group 1: Usual care
- Group 2: Electronic alert
- Group 3: Pharmacist
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is enrollment in this trial currently available to participants?
"This particular medical study is not currently looking for patients, as evidenced by the data displayed on clinicaltrials.gov which reports that the trial was first announced on July 11th 2022 and last modified on July 19th 2022. However, 170 other trials are actively recruiting participants at this time."
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