NCT07537413

Ceftriaxone Dosage for Non-Critical Community-Acquired Pneumonia

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

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 430 (estimated)
• Sponsor: University of Maryland, Baltimore · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 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.

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)

Interventions

Type	Name	Description
DRUG	Ceftriaxone 1 gram daily	Intravenous Ceftriaxone will be dosed 1 gram daily per institutional guidance for treatment of non-critical community-acquired pneumonia.
DRUG	Ceftriaxone 2 grams daily	Intravenous Ceftriaxone will be dosed at 2 grams daily per institutional guidance for treatment of community-acquired pneumonia.

Timeline

• Start date: 2026-09-01
• Primary completion: 2027-08-31
• Completion: 2028-02-28
• First posted: 2026-04-17
• Last updated: 2026-04-17

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study