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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ceftriaxone 1 gram daily | Drug | Intravenous Ceftriaxone will be dosed 1 gram daily per institutional guidance for treatment of non-critical community-acquired pneumonia. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to stability | Time in days from randomization until stability defined by temperature < 38, heart rate < 100, respiratory rate < 24, oxygen saturation > 90%, systolic blood pressure ≥ 90, and return to baseline mental status based on Glasgow Coma Score | The outcome will be assessed 90 days after enrollment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jonathan D Baghdadi, MD, PhD | Contact | 410-706-0066 | jbaghdadi@som.umaryland.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Maryland Medical Center - Midtown Campus | Baltimore | Maryland | 21201 | United States |
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| ID | Term |
|---|---|
| D000098968 | Community-Acquired Pneumonia |
| ID | Term |
|---|---|
| D017714 | Community-Acquired Infections |
| D007239 | Infections |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
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| Ceftriaxone 2 grams daily | Drug | Intravenous Ceftriaxone will be dosed at 2 grams daily per institutional guidance for treatment of community-acquired pneumonia. |
|
| Days of antibiotic therapy |
The aggregate sum of days for which any amount of a specific antimicrobial agent was administered during the hospital encounter |
| The outcome will be assessed 90 days after enrollment |
| Antibiotic escalation | Defined by a change in antibiotic therapy that may include switching to an antibiotic with a broader spectrum up activity, adding an additional antibiotic, or increasing the dose of prescribed antibiotics within 5 days of randomization | The outcome will be assessed 5 days after enrollment |
| ICU admission or requirement for mechanical ventilation | Admission to an intensive care unit or initiation of mechanical ventilation after randomization within the current hospitalization | The outcome will be assessed 90 days after enrollment |
| Hospital-free days | Number of days within a 30-day follow-up period in which the patient is not hospitalized | The outcome will be assessed 30 days after enrollment |
| All-cause readmission | Readmission for any reason within 30 days of hospital discharge | The outcome will be assessed 120 days from enrollment |
| In-hospital mortality | In-hospital death or discharge to hospice | The outcome will be assessed 90 days after enrollment |
| Antibiotic-associated adverse event | Defined by encounter-associated ICD-10 diagnosis code during the current hospitalization | The outcome will be assessed 90 days after enrollment |
| Acute liver injury | Defined by new or worsening abnormal value on liver function testing | The outcome will be assessed 90 days after enrollment |
| Clostridioides difficile infection | Positive laboratory test for Clostridioides difficile within 30 days of randomization | The outcome will be assessed 90 days after enrollment |
| Ranked composite outcome | Rank 1 (highest rank) = clinical cure as defined per the primary outcome Rank 2 = clinical cure with adverse event or abnormal liver function testing Rank 3 = intensive care unit admission or readmission Rank 4 = adverse event or liver injury and either intensive care unit admission or readmission Rank 5 = 30-day mortality | The outcome will be assessed 120 days after enrollment |
| University of Maryland Medical Center | Baltimore | Maryland | 21201 | United States |
|
| D012140 |
| Respiratory Tract Diseases |