Community Acquired Pneumonia (CAP)Phase 4DC-CAPNCT07537413
Ceftriaxone Dosage for Non-Critical Community-Acquired Pneumonia
A Phase 4 study testing Ceftriaxone 1 gram daily and Ceftriaxone 2 grams daily in people with Community Acquired Pneumonia (CAP), run by University of Maryland, Baltimore at 4 sites in United States.
Trial summary
Aim: Demonstrate the equivalent efficacy and superior safety of Ceftriaxone 1 gram daily compared with Ceftriaxone 2 grams daily among hospitalized patients with community-acquired pneumonia who are not admitted to the intensive care unit.<p> Hypothesis: Among hospitalized patients outside of the intensive care unit… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Community Acquired Pneumonia (CAP)
- What is being tested?
- Ceftriaxone 1 gram daily and Ceftriaxone 2 grams daily
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 900 participants
- Where
- 4 sitesUnited States
- Study dates
- 1 Feb 2027to 30 Sep 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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
- Evaluated in the emergency department or within 72 hours of hospitalization
- Prescribed Ceftriaxone for community-acquired pneumonia
Who cannot join
- Planned or present admission to an intensive care unit
- Respiratory failure requiring mechanical ventilation, non-invasive ventilation such as bilevel positive airway pressure, or high flow nasal cannula
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites
University of Maryland Medical Center - Midtown Campus
Baltimore, Maryland, 21201
Jonathan Baghdadi, MD, PhD, 410-225-8000, jbaghdadi@som.umaryland.edu
University of Maryland Medical Center
Baltimore, Maryland, 21201
Megan Dunning, MD, 410-328-8667, mdunning@ihv.umaryland.edu
UM Baltimore Washington Medical Center
Glen Burnie, Maryland, 21061
Stephanie Pires, PharmD, 410-787-4000, Stephanie.Pires@umm.edu
University of Maryland St. Joseph Medical Center
Towson, Maryland, 21204
Rose Kohinke, PharmD, 410-337-1000, Rose.Kohinke@umm.edu
About this study
Official title: Pragmatic Randomized Trial Evaluating Dosage of Ceftriaxone for Community-Acquired Pneumonia Outside the Intensive Care Unit
Aim: Demonstrate the equivalent efficacy and superior safety of Ceftriaxone 1 gram daily compared with Ceftriaxone 2 grams daily among hospitalized patients with community-acquired pneumonia who are not admitted to the intensive care unit.<p>
Hypothesis: Among hospitalized patients outside of the intensive care unit with community-acquired pneumonia who are prescribed Ceftriaxone, a dosage of 1 gram daily will be associated with an equivalent rate of clinical cure and fewer adverse events than a dosage of 2 grams daily.
Read the detailed description
This study will be a pragmatic trial in which prospectively enrolled patients will be randomly assigned to Ceftriaxone dosed either 1 gram or 2 grams daily. When a clinician in the emergency department or non-intensive care inpatient ward orders Ceftriaxone and selects 'community-acquired pneumonia' as the indication, the electronic health record software used at the study sites (Epic) will prompt the ordering clinician to opt into the study. No direct patient contact will occur.
- Conditions
- Community Acquired Pneumonia (CAP)
- Being tested
- Ceftriaxone 1 gram daily, Ceftriaxone 2 grams daily
- Keywords
- community acquired pneumonia, ceftriaxone, antibiotic dosing
- Medical subject headings
- Community-Acquired Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ceftriaxone 1 gram dailyDrug
Intravenous Ceftriaxone will be dosed 1 gram daily per institutional guidance for treatment of non-critical community-acquired pneumonia.
Ceftriaxone 2 grams dailyDrug
Intravenous Ceftriaxone will be dosed at 2 grams daily per institutional guidance for treatment of community-acquired pneumonia.
| Study group | Role | What they receive |
|---|---|---|
| Low Dose Ceftriaxone | Active comparator | Intravenous Ceftriaxone will be dosed 1 gram daily per institutional guidance for treatment of community-acquired pneumonia outside of the intensive care unit. Receives: Drug: Ceftriaxone 1 gram daily |
| Moderate Dose Ceftriaxone | Active comparator | Intravenous Ceftriaxone will be dosed 2 grams daily per institutional guidance for treatment of community-acquired pneumonia outside of the intensive care unit. Receives: Drug: Ceftriaxone 2 grams daily |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antibiotic escalation within 5 days of randomization
Defined by increasing the dose or frequency of Ceftriaxone, starting additional antibiotics not ordered concurrently with Ceftriaxone, or switching Ceftriaxone to an antibiotic with a broader spectrum up activity >24 hours after enrollment; antibiotic changes made on the calendar day of discharge in preparation for discharge alive from the hospital will not be considered escalation
Measured: The outcome will be assessed 5 days after enrollment
Secondary outcomes (9)
Time to stability
Time in days from randomization until stability defined by temperature < 38, heart rate < 100, respiratory rate < 24, oxygen saturation > 90%, systolic blood pressure ≥ 90, and return to baseline mental status based on Glasgow Coma Score over a 24-hour period
Measured: The outcome will be assessed 90 days after enrollment
Clinical deterioration within 10 days of randomization
Defined by admission to an intensive care unit, mechanical ventilation, or in-hospital mortality on any hospital day, or supplemental oxygen >5 L after hospital day 3 during the index encounter
Measured: The outcome will be assessed 10 days after enrollment
Ceftriaxone-associated toxicity within 10 days of randomization
Defined by new development of Hemoglobin < 10, elevated liver enzymes or or total bilirubin, clinically significant diarrhea (represented by Clostridioides difficile testing), or rash (represented by consult to dermatology)
Measured: The outcome will be assessed 10 days after enrollment
Ranked composite outcome
Rank 1 (highest rank) = no antibiotic escalation, clinical deterioration, or Ceftriaxone-associated toxicity Rank 2 = antibiotic escalation without clinical deterioration or Ceftriaxone-associated toxicity Rank 3 = Ceftriaxone-associated toxicity without clinical deterioration Rank 4 = clinical deterioration without 30-day mortality Rank 5 = 30-day mortality
Measured: The outcome will be assessed 30 days after enrollment
Duration of antibiotics
Defined as the total days of antibiotic therapy during the hospital encounter
Measured: The outcome will be assessed 90 days after enrollment
Hospital length of stay
Duration of hospitalization in days
Measured: The outcome will be assessed 90 days after enrollment
All-cause readmission
Readmission for any reason within 30 days of hospital discharge
Measured: The outcome will be assessed 90 days from enrollment
In-hospital mortality
In-hospital death or discharge to hospice
Measured: The outcome will be assessed 90 days after enrollment
Clostridioides difficile infection
Positive laboratory test for Clostridioides difficile within 30 days of randomization
Measured: The outcome will be assessed 90 days after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2026
- Study start1 Feb 2027 (estimated)
- Primary completion31 May 2028 (estimated)
- Study completion30 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Community Acquired Pneumonia (CAP)Studies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jonathan Baghdadi, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07537413
- Sponsor's protocol ID
- HP-00117776
- Acronym
- DC-CAP
- Status last verified
- Apr 2026
- First submitted
- 10 Apr 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pragmatic Randomized Trial Evaluating Dosage of Ceftriaxone for Community-Acquired Pneumonia Outside the Intensive Care Unit
- ClinicalTrials.gov ID
- NCT07537413
- Acronym / sponsor ID
- DC-CAP / HP-00117776
- Conditions
- Community Acquired Pneumonia (CAP)
- Keywords
- community acquired pneumonia, ceftriaxone, antibiotic dosing
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Study start
- 1 Feb 2027 (estimated)
- Primary completion
- 31 May 2028 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 17 Apr 2026 (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.
Aim: Demonstrate the equivalent efficacy and superior safety of Ceftriaxone 1 gram daily compared with Ceftriaxone 2 grams daily among hospitalized patients with community-acquired pneumonia who are not admitted to the intensive care unit.<p>
Hypothesis: Among hospitalized patients outside of the intensive care unit with community-acquired pneumonia who are prescribed Ceftriaxone, a dosage of 1 gram daily will be associated with an equivalent rate of clinical cure and fewer adverse events than a dosage of 2 grams daily.
Detailed description
This study will be a pragmatic trial in which prospectively enrolled patients will be randomly assigned to Ceftriaxone dosed either 1 gram or 2 grams daily. When a clinician in the emergency department or non-intensive care inpatient ward orders Ceftriaxone and selects 'community-acquired pneumonia' as the indication, the electronic health record software used at the study sites (Epic) will prompt the ordering clinician to opt into the study. No direct patient contact will occur.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low Dose Ceftriaxone | Active comparator | Drug: Ceftriaxone 1 gram dailyIntravenous Ceftriaxone will be dosed 1 gram daily per institutional guidance for treatment of community-acquired pneumonia outside of the intensive care unit. |
| Moderate Dose Ceftriaxone | Active comparator | Drug: Ceftriaxone 2 grams dailyIntravenous Ceftriaxone will be dosed 2 grams daily per institutional guidance for treatment of community-acquired pneumonia outside of the intensive care unit. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Evaluated in the emergency department or within 72 hours of hospitalization
- Prescribed Ceftriaxone for community-acquired pneumonia
Key exclusion criteria (2 listed)
- Planned or present admission to an intensive care unit
- Respiratory failure requiring mechanical ventilation, non-invasive ventilation such as bilevel positive airway pressure, or high flow nasal cannula
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 |
|---|---|---|
| Ceftriaxone 1 gram dailyIntravenous Ceftriaxone will be dosed 1 gram daily per institutional guidance for treatment of non-critical community-acquired pneumonia. | Drug | Low Dose Ceftriaxone |
| Ceftriaxone 2 grams dailyIntravenous Ceftriaxone will be dosed at 2 grams daily per institutional guidance for treatment of community-acquired pneumonia. | Drug | Moderate Dose Ceftriaxone |
Primary outcome
Antibiotic escalation within 5 days of randomization
Time frame: The outcome will be assessed 5 days after enrollment
Defined by increasing the dose or frequency of Ceftriaxone, starting additional antibiotics not ordered concurrently with Ceftriaxone, or switching Ceftriaxone to an antibiotic with a broader spectrum up activity >24 hours after enrollment; antibiotic changes made on the calendar day of discharge in preparation for discharge alive from the hospital will not be considered escalation
9 secondary outcomes
Time to stability
Time frame: The outcome will be assessed 90 days after enrollment
Clinical deterioration within 10 days of randomization
Time frame: The outcome will be assessed 10 days after enrollment
Ceftriaxone-associated toxicity within 10 days of randomization
Time frame: The outcome will be assessed 10 days after enrollment
Ranked composite outcome
Time frame: The outcome will be assessed 30 days after enrollment
Duration of antibiotics
Time frame: The outcome will be assessed 90 days after enrollment
Hospital length of stay
Time frame: The outcome will be assessed 90 days after enrollment
All-cause readmission
Time frame: The outcome will be assessed 90 days from enrollment
In-hospital mortality
Time frame: The outcome will be assessed 90 days after enrollment
Clostridioides difficile infection
Time frame: The outcome will be assessed 90 days after enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- 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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ceftriaxone 1 gram daily and Ceftriaxone 2 grams daily in people with Community Acquired Pneumonia (CAP), run by University of Maryland, Baltimore at 4 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 2 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: opening soon, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jonathan D Baghdadi, MD, PhD (410-706-0066, jbaghdadi@som.umaryland.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Antibiotic escalation within 5 days of randomization (time frame: The outcome will be assessed 5 days after enrollment). 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 5 Nov 2026.