Ceftriaxone Dosage for Non-Critical Community-Acquired Pneumonia (DC-CAP)

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.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Community Acquired Pneumonia (CAP)
• Intervention / Treatment: Drug: Ceftriaxone 1 gram daily; Drug: Ceftriaxone 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 Type: Interventional
• Enrollment (Estimated): 430
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Jonathan D Baghdadi, MD, PhD; Phone Number: 410-706-0066; Email: jbaghdadi@som.umaryland.edu

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland Medical Center
      • Contact: Megan Dunning, MD; Phone Number: 410-328-8667; Email: mdunning@ihv.umaryland.edu
    • Baltimore, Maryland, United States, 21201
      • University of Maryland Medical Center - Midtown Campus
      • Contact: Jonathan Baghdadi, MD, PhD; Phone Number: (410) 225-8000; Email: jbaghdadi@som.umaryland.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Low Dose Ceftriaxone; 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 1 gram daily per institutional guidance for treatment of non-critical community-acquired pneumonia.
Active Comparator: Moderate Dose Ceftriaxone; 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 at 2 grams daily per institutional guidance for treatment of community-acquired pneumonia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical cure	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	The outcome will be assessed 120 days after enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	The outcome will be assessed 90 days after enrollment
Days of antibiotic therapy	The aggregate sum of days for which any amount of a specific antimicrobial agent was administered during the hospital encounter	The outcome will be assessed 90 days after enrollment
Antibiotic escalation	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	The outcome will be assessed 5 days after enrollment
ICU admission or requirement for mechanical ventilation	Admission to an intensive care unit or initiation of mechanical ventilation after randomization within the current hospitalization	The outcome will be assessed 90 days after enrollment
Hospital-free days	Number of days within a 30-day follow-up period in which the patient is not hospitalized	The outcome will be assessed 30 days after enrollment
All-cause readmission	Readmission for any reason within 30 days of hospital discharge	The outcome will be assessed 120 days from enrollment
In-hospital mortality	In-hospital death or discharge to hospice	The outcome will be assessed 90 days after enrollment
Antibiotic-associated adverse event	Defined by encounter-associated ICD-10 diagnosis code during the current hospitalization	The outcome will be assessed 90 days after enrollment
Acute liver injury	Defined by new or worsening abnormal value on liver function testing	The outcome will be assessed 90 days after enrollment
Clostridioides difficile infection	Positive laboratory test for Clostridioides difficile within 30 days of randomization	The outcome will be assessed 90 days after enrollment
Ranked composite outcome	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	The outcome will be assessed 120 days after enrollment

Collaborators and Investigators

• Sponsor: University of Maryland, Baltimore

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): February 28, 2028

Study Registration Dates

• First Submitted: April 10, 2026
• First Submitted That Met QC Criteria: April 16, 2026
• First Posted (Actual): April 17, 2026

Study Record Updates

• Last Update Posted (Actual): April 17, 2026
• Last Update Submitted That Met QC Criteria: April 16, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: ceftriaxone; community acquired pneumonia; antibiotic dosing
• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; Respiratory Tract Diseases; Pneumonia; Community-Acquired Infections; Community-Acquired Pneumonia
• Other Study ID Numbers: HP-00117776

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No