Ceftriaxone 1 gram daily
DrugIntravenous Ceftriaxone will be dosed 1 gram daily per institutional guidance for treatment of non-critical community-acquired pneumonia.
NCT Number: NCT07537413
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Phase 4
University of Maryland Medical Center, Baltimore, Maryland, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: The outcome will be assessed 120 days after enrollment
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
Time frame: 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, and return to baseline mental status based on Glasgow Coma Score
Time frame: The outcome will be assessed 90 days after enrollment
The aggregate sum of days for which any amount of a specific antimicrobial agent was administered during the hospital encounter
Time frame: The outcome will be assessed 5 days after enrollment
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
Time frame: The outcome will be assessed 90 days after enrollment
Admission to an intensive care unit or initiation of mechanical ventilation after randomization within the current hospitalization
Time frame: The outcome will be assessed 30 days after enrollment
Number of days within a 30-day follow-up period in which the patient is not hospitalized
Time frame: The outcome will be assessed 120 days from enrollment
Readmission for any reason within 30 days of hospital discharge
Time frame: The outcome will be assessed 90 days after enrollment
In-hospital death or discharge to hospice
Time frame: The outcome will be assessed 90 days after enrollment
Defined by encounter-associated ICD-10 diagnosis code during the current hospitalization
Time frame: The outcome will be assessed 90 days after enrollment
Defined by new or worsening abnormal value on liver function testing
Time frame: The outcome will be assessed 90 days after enrollment
Positive laboratory test for Clostridioides difficile within 30 days of randomization
Time frame: The outcome will be assessed 120 days after enrollment
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
Contact information is provided by the study sponsor or research team.
University of Maryland, Baltimore
Other
Pragmatic Randomized Trial Evaluating Dosage of Ceftriaxone for Community-Acquired Pneumonia Outside the Intensive Care Unit
Acronym: DC-CAP
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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