PneumoniaNCT05172791
Decreasing Unnecessary Antibiotics Prescribed for Possible Pneumonia Despite Normal Respiratory Rate and Oxygenation
A study testing Antibiotic stewardship messaging in people with Pneumonia, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
The purpose of this study is to decrease unnecessary antibiotics prescribed to hospitalized patients for possible pneumonia by flagging patients with respiratory rates and oxygenation levels within reference ranges given prior data suggesting that discontinuing antibiotics in this population is safe. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumonia
- What is being tested?
- Antibiotic stewardship messaging
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 643 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jul 2022to 8 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patients under 18 years old, patients on transplant and oncology services, patients who are pregnant, patients in an intensive care unit, patients with cystic fibrosis or bronchiectasis, patients on immunosuppressive medications, and patients with positive blood cultures (other than common skin contaminants)
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Womens Hospital
Boston, Massachusetts, 02115
About this study
The purpose of this study is to decrease unnecessary antibiotics prescribed to hospitalized patients for possible pneumonia by flagging patients with respiratory rates and oxygenation levels within reference ranges given prior data suggesting that discontinuing antibiotics in this population is safe. Patients will be randomized to 3 arms: 1) usual care, 2) electronic alert, or 3) pharmacist outreach.
Read the detailed description
Prior data suggest antibiotic starts for patients with normal vital signs are common and there does not appear to be harm associated with stopping antibiotics after only 1 or 2 days in patients with normal oxygen saturations. We therefore propose a pilot patient-level three-way randomized trial to determine the best way to operationalize professional society recommendations for post-prescription antibiotic reviews amongst patients started on antibiotics with a stated indication of pneumonia despite normal respiratory rates and oxygenation levels. If the patient's median respiratory rate and oxygen saturation is normal after 1-2 days of antibiotics they will be randomized to usual care versus a EHR-based best practice alert versus pharmacist outreach. The EHR-based best practice alert will highlight the patient's normal respiratory rate and oxygenation and encourage stopping antibiotics if there isn't another indication for antibiotics. Pharmacist outreach will involve contacting the responding clinician or attending physician to determine the working diagnosis, review the patient's vital signs, and to ask the team to consider stopping antibiotics if there are no clear indications for antibiotics. In all cases, the final decision on whether to stop or continue antibiotics will be up to the primary team. We will assess the impact of these post-prescription review strategies to decrease unnecessary antibiotic utilization on antibiotic utilization (antibiotic days and antibiotic-free days) compared to usual care. Safety outcomes will include time to discharge, readmissions, hospital-free days, and mortality. We will also assess for change in the primary outcome over time.
- Conditions
- Pneumonia
- Being tested
- Antibiotic stewardship messaging
- Keywords
- antibiotic stewardship, pneumonia
- Medical subject headings
- Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antibiotic stewardship messagingBehavioural
Counseling regarding antibiotics for patients prescribed antibiotics for possible pneumonia despite respiratory rates and oxygenation levels within normal ranges
| Study group | Role | What they receive |
|---|---|---|
| Usual care | No intervention | Clinical teams will decide on antibiotic duration for patients with possible pneumonia without external prompting |
| Electronic alert | Experimental | 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 Receives: Behavioral: Antibiotic stewardship messaging |
| Pharmacist | Experimental | 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. Receives: Behavioral: Antibiotic stewardship messaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of antibiotics prescribed for pneumonia
Duration of antibiotics prescribed for pneumonia
Measured: Number of days of antibiotics given during hospitalization plus number of days of antibiotics for pneumonia on discharge prescriptions, up to 30 days
Secondary outcomes (8)
Antibiotic-free days in the 30-days post-randomization
Antibiotic-free days in the 30-days post-randomization
Measured: 30-days post-randomization
Days from randomization to discharge
Days from randomization to discharge
Measured: Duration of hospitalization, up to 90 days
Hospital length of stay
Hospital length of stay
Measured: Duration of hospitalization, up to 90 days
In-hospital mortality
In-hospital mortality
Measured: During initial hospitalization with pneumonia, up to 90 days
Readmissions within 30-days of randomization
Readmissions within 30-days of randomization
Measured: 30-days post-randomization
Hospital-free days in the 30-days post-randomization
Hospital-free days in the 30-days post-randomization
Measured: 30-days post-randomization
C. difficile infections in the 30-days post-randomization
- difficile infections in the 30-days post-randomization
Measured: 30-days post-randomization
Acute kidney injury (maximum creatinine in the 14-days post-randomization)
Acute kidney injury (maximum creatinine in the 14-days post-randomization)
Measured: 14 days post-randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2021
- Study start11 Jul 2022
- Primary completion10 Jul 2024
- Study completion8 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PneumoniaStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 643 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Responsible party
- Principal investigator, Michael Klompas, M.D., Brigham and Women's Hospital
- Investigators
- Michael Klompas, MD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05172791
- Sponsor's protocol ID
- 2021p002282
- Status last verified
- Aug 2023
- First submitted
- 1 Dec 2021
- Last updated
- 21 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Decreasing Unnecessary Antibiotics Prescribed for Possible Pneumonia Despite Normal Respiratory Rate and Oxygenation
- ClinicalTrials.gov ID
- NCT05172791
- Acronym / sponsor ID
- 2021p002282
- Conditions
- Pneumonia
- Keywords
- antibiotic stewardship, pneumonia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 643 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- 11 Jul 2022 (actual)
- Primary completion
- 10 Jul 2024 (actual)
- Study completion
- 8 Oct 2024 (actual)
- First posted
- 29 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to decrease unnecessary antibiotics prescribed to hospitalized patients for possible pneumonia by flagging patients with respiratory rates and oxygenation levels within reference ranges given prior data suggesting that discontinuing antibiotics in this population is safe. Patients will be randomized to 3 arms: 1) usual care, 2) electronic alert, or 3) pharmacist outreach.
Detailed description
Prior data suggest antibiotic starts for patients with normal vital signs are common and there does not appear to be harm associated with stopping antibiotics after only 1 or 2 days in patients with normal oxygen saturations. We therefore propose a pilot patient-level three-way randomized trial to determine the best way to operationalize professional society recommendations for post-prescription antibiotic reviews amongst patients started on antibiotics with a stated indication of pneumonia despite normal respiratory rates and oxygenation levels. If the patient's median respiratory rate and oxygen saturation is normal after 1-2 days of antibiotics they will be randomized to usual care versus a EHR-based best practice alert versus pharmacist outreach. The EHR-based best practice alert will highlight the patient's normal respiratory rate and oxygenation and encourage stopping antibiotics if there isn't another indication for antibiotics. Pharmacist outreach will involve contacting the responding clinician or attending physician to determine the working diagnosis, review the patient's vital signs, and to ask the team to consider stopping antibiotics if there are no clear indications for antibiotics. In all cases, the final decision on whether to stop or continue antibiotics will be up to the primary team. We will assess the impact of these post-prescription review strategies to decrease unnecessary antibiotic utilization on antibiotic utilization (antibiotic days and antibiotic-free days) compared to usual care. Safety outcomes will include time to discharge, readmissions, hospital-free days, and mortality. We will also assess for change in the primary outcome over time.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Usual care | No intervention | –Clinical teams will decide on antibiotic duration for patients with possible pneumonia without external prompting |
| Electronic alert | Experimental | Behavioral: Antibiotic stewardship messagingAn 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 |
| Pharmacist | Experimental | Behavioral: Antibiotic stewardship messagingPharmacists 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients under 18 years old, patients on transplant and oncology services, patients who are pregnant, patients in an intensive care unit, patients with cystic fibrosis or bronchiectasis, patients on immunosuppressive medications, and patients with positive blood cultures (other than common skin contaminants)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Antibiotic stewardship messagingCounseling regarding antibiotics for patients prescribed antibiotics for possible pneumonia despite respiratory rates and oxygenation levels within normal ranges | Behavioural | Electronic alert, Pharmacist |
Primary outcome
Duration of antibiotics prescribed for pneumonia
Time frame: Number of days of antibiotics given during hospitalization plus number of days of antibiotics for pneumonia on discharge prescriptions, up to 30 days
Duration of antibiotics prescribed for pneumonia
8 secondary outcomes
Antibiotic-free days in the 30-days post-randomization
Time frame: 30-days post-randomization
Days from randomization to discharge
Time frame: Duration of hospitalization, up to 90 days
Hospital length of stay
Time frame: Duration of hospitalization, up to 90 days
In-hospital mortality
Time frame: During initial hospitalization with pneumonia, up to 90 days
Readmissions within 30-days of randomization
Time frame: 30-days post-randomization
Hospital-free days in the 30-days post-randomization
Time frame: 30-days post-randomization
C. difficile infections in the 30-days post-randomization
Time frame: 30-days post-randomization
Acute kidney injury (maximum creatinine in the 14-days post-randomization)
Time frame: 14 days post-randomization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Klompas, MD principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Antibiotic stewardship messaging in people with Pneumonia, run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of antibiotics prescribed for pneumonia (time frame: Number of days of antibiotics given during hospitalization plus number of days of antibiotics for pneumonia on discharge prescriptions, up to 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2025.