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 Sep 2026to 28 Feb 2028
- Phase
- Phase 4
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 changing Ceftriaxone to an antibiotic with a broader spectrum up activity
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, return to baseline mental status based on Glasgow Coma Score, and PO diet or medication ordered
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 >2 L after hospital day 3
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 Sep 2026 (estimated)
- Primary completion31 Aug 2027 (estimated)
- Study completion28 Feb 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.
- 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
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No