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NCT Number: NCT07537413

Ceftriaxone Dosage for Non-Critical Community-Acquired Pneumonia

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.

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Key information

Conditions

Community Acquired Pneumonia (CAP) Community-Acquired Infections Community-Acquired Pneumonia Infections Pneumonia Respiratory Tract Diseases Respiratory Tract Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Maryland Medical Center, Baltimore, Maryland, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Evaluated in the emergency department or within 72 hours of hospitalization
  • Prescribed Ceftriaxone for community-acquired pneumonia

Exclusion criteria

  • 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

Treatment and study plan

Ceftriaxone 1 gram daily

Drug

Intravenous Ceftriaxone will be dosed 1 gram daily per institutional guidance for treatment of non-critical community-acquired pneumonia.

Ceftriaxone 2 grams daily

Drug

Intravenous Ceftriaxone will be dosed at 2 grams daily per institutional guidance for treatment of community-acquired pneumonia.

Primary outcomes

  1. 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 changing Ceftriaxone to an antibiotic with a broader spectrum up activity

Secondary outcomes

  1. Time to stability

    Time frame: The outcome will be assessed 90 days after enrollment

    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

  2. Clinical deterioration within 10 days of randomization

    Time frame: The outcome will be assessed 10 days after enrollment

    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

  3. Ceftriaxone-associated toxicity within 10 days of randomization

    Time frame: The outcome will be assessed 10 days after enrollment

    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)

  4. Ranked composite outcome

    Time frame: The outcome will be assessed 30 days after enrollment

    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

  5. Duration of antibiotics

    Time frame: The outcome will be assessed 90 days after enrollment

    Defined as the total days of antibiotic therapy during the hospital encounter

  6. Hospital length of stay

    Time frame: The outcome will be assessed 90 days after enrollment

    Duration of hospitalization in days

  7. All-cause readmission

    Time frame: The outcome will be assessed 90 days from enrollment

    Readmission for any reason within 30 days of hospital discharge

  8. In-hospital mortality

    Time frame: The outcome will be assessed 90 days after enrollment

    In-hospital death or discharge to hospice

  9. Clostridioides difficile infection

    Time frame: The outcome will be assessed 90 days after enrollment

    Positive laboratory test for Clostridioides difficile within 30 days of randomization

Interested in participating?

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Sponsors and collaborators

Lead sponsor

University of Maryland, Baltimore

Other

Registry information

Official study title

Pragmatic Randomized Trial Evaluating Dosage of Ceftriaxone for Community-Acquired Pneumonia Outside the Intensive Care Unit

Acronym: DC-CAP

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Apr 17, 2026
Registry last updated
Sep 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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