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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

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. Clinical cure

    Time frame: The outcome will be assessed 120 days after enrollment

    Defined by discharge from the hospital or antibiotic treatment for < 8 days without any of the following: requirement for antibiotic escalation, admission to an intensive care unit, mechanical or noninvasive ventilation, readmission within 30 days, or mortality within 30 days

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, and return to baseline mental status based on Glasgow Coma Score

  2. Days of antibiotic therapy

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

    The aggregate sum of days for which any amount of a specific antimicrobial agent was administered during the hospital encounter

  3. Antibiotic escalation

    Time frame: The outcome will be assessed 5 days after enrollment

    Defined by a change in antibiotic therapy that may include switching to an antibiotic with a broader spectrum up activity, adding an additional antibiotic, or increasing the dose of prescribed antibiotics within 5 days of randomization

  4. ICU admission or requirement for mechanical ventilation

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

    Admission to an intensive care unit or initiation of mechanical ventilation after randomization within the current hospitalization

  5. Hospital-free days

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

    Number of days within a 30-day follow-up period in which the patient is not hospitalized

  6. All-cause readmission

    Time frame: The outcome will be assessed 120 days from enrollment

    Readmission for any reason within 30 days of hospital discharge

  7. In-hospital mortality

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

    In-hospital death or discharge to hospice

  8. Antibiotic-associated adverse event

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

    Defined by encounter-associated ICD-10 diagnosis code during the current hospitalization

  9. Acute liver injury

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

    Defined by new or worsening abnormal value on liver function testing

  10. 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

  11. Ranked composite outcome

    Time frame: The outcome will be assessed 120 days after enrollment

    Rank 1 (highest rank) = clinical cure as defined per the primary outcome Rank 2 = clinical cure with adverse event or abnormal liver function testing Rank 3 = intensive care unit admission or readmission Rank 4 = adverse event or liver injury and either intensive care unit admission or readmission Rank 5 = 30-day mortality

Study contacts

Contact information is provided by the study sponsor or research team.

Jonathan D Baghdadi, MD, PhD

CONTACT

[email protected]

410-706-0066

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
Apr 17, 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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