Ceftriaxone Dosage for Non-Critical Community-Acquired Pneumonia

NCT07537413 | Not Yet Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: HP-00117776
• Study Type: interventional
• Target: 430
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Community Acquired Pneumonia (CAP)

Keywords

community acquired pneumonia; ceftriaxone; antibiotic dosing

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Time to stability

  The outcome will be assessed 90 days after enrollment

• Days of antibiotic therapy

  The outcome will be assessed 90 days after enrollment

• Antibiotic escalation

  The outcome will be assessed 5 days after enrollment

• ICU admission or requirement for mechanical ventilation

  The outcome will be assessed 90 days after enrollment

• Hospital-free days

  The outcome will be assessed 30 days after enrollment

Study Arms (2)

Low Dose Ceftriaxone

ACTIVE COMPARATOR

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

Moderate Dose Ceftriaxone

ACTIVE COMPARATOR

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

Interventions

Ceftriaxone 1 gram daily DRUG

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

Low Dose Ceftriaxone

Ceftriaxone 2 grams daily DRUG

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

Moderate Dose Ceftriaxone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Maryland, Baltimore: lead

Study Sites (2)

University of Maryland Medical Center - Midtown Campus

Baltimore, Maryland, 21201, United States

Location

University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Conditions

Community-Acquired Pneumonia

Condition Hierarchy (Ancestors)

Community-Acquired Infections; Infections; Pneumonia; Respiratory Tract Infections; Respiratory Tract Diseases

Central Study Contacts

Jonathan D Baghdadi, MD, PhD

CONTACT

410-706-0066; jbaghdadi@som.umaryland.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Epidemiology and Public Health

Study Record Dates

• First Submitted: April 10, 2026
• First Posted: April 17, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): February 28, 2028
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)