A Phase 4 interventional study of Ceftriaxone 1 gram daily and Ceftriaxone 2 grams daily in Community Acquired Pneumonia (CAP), sponsored by University of Maryland, Baltimore. Not yet recruiting at 4 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-05.
Sponsored by University of Maryland, Baltimore · Phase 4, Interventional, and Treatment
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.
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.
324 studies on the registry are indexed under Community-Acquired Pneumonia; 77 are open to participants now.
This study's planned enrollment of 900 is above the median of 250 across 195 interventional studies indexed under Community-Acquired Pneumonia.
Browse Community-Acquired Pneumonia studies →University of Maryland, Baltimore is the lead sponsor of 700 studies on the registry; 132 are open to participants now.
Of its 92 completed or terminated interventional studies of FDA-regulated products, 66 (72%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Intravenous Ceftriaxone will be dosed 1 gram daily per institutional guidance for treatment of community-acquired pneumonia outside of the intensive care unit.
Drug: Ceftriaxone 1 gram daily
Intravenous Ceftriaxone will be dosed 2 grams daily per institutional guidance for treatment of community-acquired pneumonia outside of the intensive care unit.
Drug: Ceftriaxone 2 grams daily
Intravenous Ceftriaxone will be dosed 1 gram daily per institutional guidance for treatment of non-critical community-acquired pneumonia.
Intravenous Ceftriaxone will be dosed at 2 grams daily per institutional guidance for treatment of community-acquired pneumonia.
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
Time frame: The outcome will be assessed 5 days after enrollment
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
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: The outcome will be assessed 30 days after enrollment
Duration of antibiotics
Defined as the total days of antibiotic therapy during the hospital encounter
Time frame: The outcome will be assessed 90 days after enrollment
Hospital length of stay
Duration of hospitalization in days
Time frame: The outcome will be assessed 90 days after enrollment
All-cause readmission
Readmission for any reason within 30 days of hospital discharge
Time frame: The outcome will be assessed 90 days from enrollment
In-hospital mortality
In-hospital death or discharge to hospice
Time frame: The outcome will be assessed 90 days after enrollment
Clostridioides difficile infection
Positive laboratory test for Clostridioides difficile within 30 days of randomization
Time frame: The outcome will be assessed 90 days after enrollment
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Feb 2027; primary completion for May 2028, 15 months later.
Since we started tracking on Sep 25, 2026, the dates moved once, on Nov 5, 2026: start Sep 2026 → Feb 2027, primary completion Aug 2027 → May 2028 and completion Feb 2028 → Sep 2028.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Community-Acquired Pneumonia →
University of Maryland, Baltimore →