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Not yet recruiting NCT07537413

Ceftriaxone Dosage for Non-Critical Community-Acquired Pneumonia

Phase IV Interventional Community Acquired Pneumonia (CAP)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Ceftriaxone 1 gram daily, Ceftriaxone 2 grams daily.
Who it may be relevant to
Registry conditions: Community Acquired Pneumonia (CAP). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Pragmatic Randomized Trial Evaluating Dosage of Ceftriaxone for Community-Acquired Pneumonia Outside the Intensive Care Unit

Overview

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

  • Drug Ceftriaxone 1 gram daily
    Intravenous Ceftriaxone will be dosed 1 gram daily per institutional guidance for treatment of non-critical community-acquired pneumonia.
  • Drug Ceftriaxone 2 grams daily
    Intravenous Ceftriaxone will be dosed at 2 grams daily per institutional guidance for treatment of community-acquired pneumonia.

Primary outcome measures

  • Clinical cure [Time frame: The outcome will be assessed 120 days after enrollment]
Secondary outcome measures (11)
  • Time to stability [Time frame: The outcome will be assessed 90 days after enrollment]
  • Days of antibiotic therapy [Time frame: The outcome will be assessed 90 days after enrollment]
  • Antibiotic escalation [Time frame: The outcome will be assessed 5 days after enrollment]
  • ICU admission or requirement for mechanical ventilation [Time frame: The outcome will be assessed 90 days after enrollment]
  • Hospital-free days [Time frame: The outcome will be assessed 30 days after enrollment]
  • All-cause readmission [Time frame: The outcome will be assessed 120 days from enrollment]
  • In-hospital mortality [Time frame: The outcome will be assessed 90 days after enrollment]
  • Antibiotic-associated adverse event [Time frame: The outcome will be assessed 90 days after enrollment]
  • Acute liver injury [Time frame: The outcome will be assessed 90 days after enrollment]
  • Clostridioides difficile infection [Time frame: The outcome will be assessed 90 days after enrollment]
  • Ranked composite outcome [Time frame: The outcome will be assessed 120 days after enrollment]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 2 centers
  • University of Maryland Medical Center - Midtown Campus — Baltimore
  • University of Maryland Medical Center — Baltimore

Identifiers

NCT: NCT07537413 · HP-00117776

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗