PneumoniaUP-CAPTAInNCT05976581
Using Probability of Community-Acquired Pneumonia to Tailor Antimicrobials Among Inpatients
A study testing Electronic alert and Structured communication of test results in people with Pneumonia and Pneumonia, Viral, run by Jonathan Baghdadi at 2 sites in United States.
Trial summary
The goal of this prospective randomized study is to improve antibiotic use among hospitalized patients with suspected pneumonia. An alert was built into the electronic health record to guide use of diagnostic testing based on probability of bacterial pneumonia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumonia, Pneumonia, Viral, Pneumonia, Bacterial
- What is being tested?
- Electronic alert and Structured communication of test results
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Nov 2023to 31 May 2025
- 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
- Adult patients admitted to the University of Maryland Medical Center or University of Maryland Medical Center-Midtown Campus who are prescribed antibiotics for suspected community-acquired respiratory infection.
- Protocol-based diagnostic testing supports possible viral infection, either by positive molecular test or low procalcitonin value.
Who cannot join
- Hospitalization for >72 hours prior to protocol-based diagnostic testing.
- Previous molecular testing for viral infection during the same hospital encounter.
- Severely immunosuppressed, defined as having hematologic malignancy, solid organ tumor on chemotherapy, or solid organ transplant on immunosuppression
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Maryland Medical Center - Midtown Campus
Baltimore, Maryland, 21201
University of Maryland Medical Center
Baltimore, Maryland, 21201
About this study
The goal of this prospective randomized study is to improve antibiotic use among hospitalized patients with suspected pneumonia. An alert was built into the electronic health record to guide use of diagnostic testing based on probability of bacterial pneumonia. Patients with test results suggesting viral infection will be randomized to either: (1) receive a structured communication from the antimicrobial stewardship team to de-escalate antibiotics or (2) usual care.
Read the detailed description
Low-risk patients with viral pneumonia do not benefit from and may be harmed by antibiotic therapy. In this study, an alert will appear in the electronic health record of patients undergoing molecular diagnostic testing for respiratory symptoms that provides options for diagnostic testing based on pre-test probability of bacterial infection. Patients with test results suggesting possible viral infection will be randomized to either usual care or to receive test results along with structured guidance from antimicrobial stewardship to consider discontinuing or de-escalating antibiotics. This guidance, which will include an explicit calculation of the post-test probability of bacterial infection based on considering risk factors, vital signs, symptoms, and available imaging, will be communicated to the primary care team via direct electronic message and a summary note in the patient's chart. The final decision on whether to continue antibiotic therapy will be up to the primary team. The primary outcome of interest will be in-hospital antibiotic use. Safety outcomes will include length of stay, readmissions, hospital-free days, and mortality.
- Conditions
- Pneumonia, Pneumonia, Viral, Pneumonia, Bacterial
- Being tested
- Electronic alert, Structured communication of test results
- Keywords
- diagnostic stewardship, antimicrobial stewardship
- Medical subject headings
- Pneumonia, Pneumonia, Viral, Pneumonia, Bacterial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electronic alertBehavioural
An alert will appear in the electronic health record that provides options for diagnostic testing based on low, medium, or high probability of bacterial pneumonia.
Structured communication of test resultsBehavioural
A clinical research team member will send an electronic message to the primary care team on behalf of the antimicrobial stewardship program with structured guidance to stop or de-escalate antibiotics and document these recommendations in the patient's chart.
| Study group | Role | What they receive |
|---|---|---|
| Electronic alert plus structured communication of test results | Experimental | An electronic health record alert will guide diagnostic testing for pneumonia. For patients with low or moderate probability of bacterial pneumonia, test results will be communicated to the primary team with guidance to consider discontinuing or de-escalating antibiotics. Receives: Behavioral: Electronic alert; Behavioral: Structured communication of test results |
| Electronic alert without structured communication of test results | Active comparator | An electronic health record alert will guide diagnostic testing for pneumonia. The primary care team will access and interpret test results and decide upon composition and duration of antimicrobial without external guidance. Receives: Behavioral: Electronic alert |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital antibiotic days of therapy
The aggregate sum of days for which any amount of a specific antimicrobial agent was administered during the hospital encounter, from arrival in the emergency department or on the hospital ward until discharge.
Measured: Up to 90 days after randomization
Secondary outcomes (8)
Hospital length of stay
Duration of hospitalization from admission to discharge
Measured: Up to 90 days after randomization
In-hospital mortality
Death or discharge to hospice during initial hospitalization for any cause
Measured: Up to 90 days after randomization
Readmissions within 30-days of randomization
Readmissions for any cause within 30-days of randomization
Measured: Within 30 days after randomization
C. difficile infections in the 30-days post-randomization
Positive test for C. difficile associated with initiation of antibiotics targeting C. difficile.
Measured: Within 30 days after randomization
Acute kidney injury
Defined by an elevation in creatinine of > 0.5mg/dl or 2x baseline in a patient without previous end-stage renal disease.
Measured: Within 14 days of randomization
Ventilator-free days in the 30-days post-randomization
Days without a requirement for mechanical ventilation in the 30 days after randomization.
Measured: 30 days after randomization.
Hospital-free days in the 30-days post-randomization
Days without hospitalization in the 30 days after randomization.
Measured: 30 days after randomization.
Antibiotic de-escalations within 72 hours after initiation
Including narrowing, discontinuing, or converting the route of administration from intravenous to oral.
Measured: 3 days after randomization.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2023
- Study start1 Nov 2023
- Primary completion10 Jan 2025
- Study completion31 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PneumoniaStudies of the same condition, open and under way.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study involves a randomized trial embedded within a quasi-experiment. During the 1-year study period, we anticipate that 1,500 patients will be exposed to the electronic health record modification performed as part of the quasi-experiment. Regarding the randomized trial, if 100 patients are enrolled during the 1-year study period, including 50 in intervention patients and 50 controls, we anticipate that we will have sufficient precision to estimate the difference in binary outcomes (e.g., antibiotic discontinuation within 5 days) between the two groups with a margin of error of approximately 15% based on a 95% confidence interval.
- Masking
- None (open label)
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jonathan Baghdadi
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Responsible party
- Sponsor-investigator, Jonathan Baghdadi, University of Maryland, Baltimore
- Investigators
- Daniel J. Morgan, MD, MS, Principal investigator, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05976581
- Sponsor's protocol ID
- HP-00103497
- Acronym
- UP-CAPTAIn
- Status last verified
- Apr 2026
- First submitted
- 11 Jul 2023
- Last updated
- 14 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Baghdadi JD, Harris AD, Pineles L, Al-Shanqeeti S, Palacio D, Charles DW, Heil E, Claeys KC, Bork JT, Sommerkamp S, Wilkerson RG, Godwin G, Sutherland ME, Johnson JK, Morgan DJ. Using Probability of Community-Acquired Pneumonia to Tailor Antimicrobials Among Inpatients: A Pragmatic, Randomized Trial. Clin Infect Dis. 2026 Jul 8;82(6):954-961. doi: 10.1093/cid/ciag126.
PubMed 41823187
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Probability of Community-Acquired Pneumonia to Tailor Antimicrobials Among Inpatients
- ClinicalTrials.gov ID
- NCT05976581
- Acronym / sponsor ID
- UP-CAPTAIn / HP-00103497
- Conditions
- Pneumonia, Pneumonia, Viral, Pneumonia, Bacterial
- Keywords
- diagnostic stewardship, antimicrobial stewardship
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Jonathan BaghdadiUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 10 Jan 2025 (actual)
- Study completion
- 31 May 2025 (actual)
- First posted
- 4 Aug 2023 (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 goal of this prospective randomized study is to improve antibiotic use among hospitalized patients with suspected pneumonia. An alert was built into the electronic health record to guide use of diagnostic testing based on probability of bacterial pneumonia. Patients with test results suggesting viral infection will be randomized to either: (1) receive a structured communication from the antimicrobial stewardship team to de-escalate antibiotics or (2) usual care.
Detailed description
Low-risk patients with viral pneumonia do not benefit from and may be harmed by antibiotic therapy. In this study, an alert will appear in the electronic health record of patients undergoing molecular diagnostic testing for respiratory symptoms that provides options for diagnostic testing based on pre-test probability of bacterial infection. Patients with test results suggesting possible viral infection will be randomized to either usual care or to receive test results along with structured guidance from antimicrobial stewardship to consider discontinuing or de-escalating antibiotics. This guidance, which will include an explicit calculation of the post-test probability of bacterial infection based on considering risk factors, vital signs, symptoms, and available imaging, will be communicated to the primary care team via direct electronic message and a summary note in the patient's chart. The final decision on whether to continue antibiotic therapy will be up to the primary team. The primary outcome of interest will be in-hospital antibiotic use. Safety outcomes will include length of stay, readmissions, hospital-free days, and mortality.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study involves a randomized trial embedded within a quasi-experiment. During the 1-year study period, we anticipate that 1,500 patients will be exposed to the electronic health record modification performed as part of the quasi-experiment. Regarding the randomized trial, if 100 patients are enrolled during the 1-year study period, including 50 in intervention patients and 50 controls, we anticipate that we will have sufficient precision to estimate the difference in binary outcomes (e.g., antibiotic discontinuation within 5 days) between the two groups with a margin of error of approximately 15% based on a 95% confidence interval.
| Arm | Type | Receives |
|---|---|---|
| Electronic alert plus structured communication of test results | Experimental | Behavioral: Electronic alert, Behavioral: Structured communication of test resultsAn electronic health record alert will guide diagnostic testing for pneumonia. For patients with low or moderate probability of bacterial pneumonia, test results will be communicated to the primary team with guidance to consider discontinuing or de-escalating antibiotics. |
| Electronic alert without structured communication of test results | Active comparator | Behavioral: Electronic alertAn electronic health record alert will guide diagnostic testing for pneumonia. The primary care team will access and interpret test results and decide upon composition and duration of antimicrobial without external guidance. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patients admitted to the University of Maryland Medical Center or University of Maryland Medical Center-Midtown Campus who are prescribed antibiotics for suspected community-acquired respiratory infection.
- Protocol-based diagnostic testing supports possible viral infection, either by positive molecular test or low procalcitonin value.
Key exclusion criteria (3 listed)
- Hospitalization for >72 hours prior to protocol-based diagnostic testing.
- Previous molecular testing for viral infection during the same hospital encounter.
- Severely immunosuppressed, defined as having hematologic malignancy, solid organ tumor on chemotherapy, or solid organ transplant on immunosuppression
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 |
|---|---|---|
| Electronic alertAn alert will appear in the electronic health record that provides options for diagnostic testing based on low, medium, or high probability of bacterial pneumonia. | Behavioural | Electronic alert plus structured communication of test results, Electronic alert without structured communication of test results |
| Structured communication of test resultsA clinical research team member will send an electronic message to the primary care team on behalf of the antimicrobial stewardship program with structured guidance to stop or de-escalate antibiotics and document these recommendations in the patient's chart. | Behavioural | Electronic alert plus structured communication of test results |
Primary outcome
Hospital antibiotic days of therapy
Time frame: Up to 90 days after randomization
The aggregate sum of days for which any amount of a specific antimicrobial agent was administered during the hospital encounter, from arrival in the emergency department or on the hospital ward until discharge.
8 secondary outcomes
Hospital length of stay
Time frame: Up to 90 days after randomization
In-hospital mortality
Time frame: Up to 90 days after randomization
Readmissions within 30-days of randomization
Time frame: Within 30 days after randomization
C. difficile infections in the 30-days post-randomization
Time frame: Within 30 days after randomization
Acute kidney injury
Time frame: Within 14 days of randomization
Ventilator-free days in the 30-days post-randomization
Time frame: 30 days after randomization.
Hospital-free days in the 30-days post-randomization
Time frame: 30 days after randomization.
Antibiotic de-escalations within 72 hours after initiation
Time frame: 3 days after 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 14 Apr 2026.
- Results publication: PubMed 41823187Baghdadi JD, Harris AD, Pineles L, Al-Shanqeeti S, Palacio D, Charles DW, Heil E, Claeys KC, Bork JT, Sommerkamp S, Wilkerson RG, Godwin G, Sutherland ME, Johnson JK, Morgan DJ. Using Probability of Community-Acquired Pneumonia to Tailor Antimicrobials Among Inpatients: A Pragmatic, Randomized Trial. Clin Infect Dis. 2026 Jul 8;82(6):954-961. doi: 10.1093/cid/ciag126.
- 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.
Daniel J. Morgan, MD, MS principal investigator
University of Maryland, Baltimore
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electronic alert and Structured communication of test results in people with Pneumonia and Pneumonia, Viral, run by Jonathan Baghdadi at 2 sites 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 2 inclusion and 3 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 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Hospital antibiotic days of therapy (time frame: Up to 90 days after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05976581, which also lists 1 linked publication.
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 14 Apr 2026; AzTrials last refreshed its copy on 7 Nov 2026.