Community Acquired Pneumonia (CAP)
Conditions
Keywords
community acquired pneumonia, ceftriaxone, antibiotic dosing
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.
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.
Interventions
DRUGCeftriaxone 1 gram daily
Intravenous Ceftriaxone will be dosed 1 gram daily per institutional guidance for treatment of non-critical community-acquired pneumonia.
Intravenous Ceftriaxone will be dosed at 2 grams daily per institutional guidance for treatment of community-acquired pneumonia.
Sponsors
University of Maryland, Baltimore
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Antibiotic escalation within 5 days of randomization | The outcome will be assessed 5 days after enrollment | Defined by increasing the dose or frequency of Ceftriaxone, starting additional antibiotics not ordered concurrently with Ceftriaxone, or changing Ceftriaxone to an antibiotic with a broader spectrum up activity |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to stability | The outcome will be assessed 90 days after enrollment | Time in days from randomization until stability defined by temperature \< 38, heart rate \< 100, respiratory rate \< 24, oxygen saturation \> 90%, systolic blood pressure ≥ 90, return to baseline mental status based on Glasgow Coma Score, and PO diet or medication ordered |
| Clinical deterioration within 10 days of randomization | The outcome will be assessed 10 days after enrollment | Defined by admission to an intensive care unit, mechanical ventilation, or in-hospital mortality on any hospital day, or supplemental oxygen \>2 L after hospital day 3 |
| Ceftriaxone-associated toxicity within 10 days of randomization | The outcome will be assessed 10 days after enrollment | Defined by new development of Hemoglobin \< 10, elevated liver enzymes or or total bilirubin, clinically significant diarrhea (represented by Clostridioides difficile testing), or rash (represented by consult to dermatology) |
| Ranked composite outcome | The outcome will be assessed 30 days after enrollment | Rank 1 (highest rank) = no antibiotic escalation, clinical deterioration, or Ceftriaxone-associated toxicity Rank 2 = antibiotic escalation without clinical deterioration or Ceftriaxone-associated toxicity Rank 3 = Ceftriaxone-associated toxicity without clinical deterioration Rank 4 = clinical deterioration without 30-day mortality Rank 5 = 30-day mortality |
| Duration of antibiotics | The outcome will be assessed 90 days after enrollment | Defined as the total days of antibiotic therapy during the hospital encounter |
| Hospital length of stay | The outcome will be assessed 90 days after enrollment | Duration of hospitalization in days |
| All-cause readmission | The outcome will be assessed 90 days from enrollment | Readmission for any reason within 30 days of hospital discharge |
| In-hospital mortality | The outcome will be assessed 90 days after enrollment | In-hospital death or discharge to hospice |
| Clostridioides difficile infection | The outcome will be assessed 90 days after enrollment | Positive laboratory test for Clostridioides difficile within 30 days of randomization |
Countries
United States
Contacts
CONTACTJonathan D Baghdadi, MD, PhD
Outcome results
None listed