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

University of Maryland Baltimore (UMB)

Status and phase: Begins enrollment in 3 months; Phase 4

Conditions: Community Acquired Pneumonia (CAP)

Treatments: Drug: Ceftriaxone 1 gram daily; Drug: Ceftriaxone 2 grams daily

Study type: Interventional

Funder types: Other

Identifiers

NCT07537413

HP-00117776

Details and patient eligibility

About

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.

Full 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.

Enrollment: 430 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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430 participants in 2 patient groups

Low Dose Ceftriaxone

Active Comparator group

Description:

Intravenous Ceftriaxone will be dosed 1 gram daily per institutional guidance for treatment of community-acquired pneumonia outside of the intensive care unit.

Treatment:

Drug: Ceftriaxone 1 gram daily

Moderate Dose Ceftriaxone

Active Comparator group

Description:

Intravenous Ceftriaxone will be dosed 2 grams daily per institutional guidance for treatment of community-acquired pneumonia outside of the intensive care unit.

Treatment:

Drug: Ceftriaxone 2 grams daily