Pragmatic Randomized Trial Evaluating Dosage of Ceftriaxone for Community-Acquired Pneumonia Outside the Intensive Care Unit
University of Maryland, Baltimore
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.
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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
Interventions
- DrugCeftriaxone 1 gram daily
Intravenous Ceftriaxone will be dosed 1 gram daily per institutional guidance for treatment of non-critical community-acquired pneumonia.
- DrugCeftriaxone 2 grams daily
Intravenous Ceftriaxone will be dosed at 2 grams daily per institutional guidance for treatment of community-acquired pneumonia.
Locations (2)
- University of Maryland Medical Center - Midtown CampusBaltimore, Maryland
- University of Maryland Medical CenterBaltimore, Maryland