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Not yet recruiting Phase 4 NCT07537413

Ceftriaxone Dosage for Non-Critical Community-Acquired Pneumonia

Phase 4 – monitoring after market approval
Conditions: Community Acquired Pneumonia (CAP)

Sponsor: University of Maryland, Baltimore

trial.available_in: БГ
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.
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.
Who can participate
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
Ceftriaxone 1 gram daily
DRUG
Ceftriaxone 2 grams daily
DRUG
Locations 2
United States (2)
University of Maryland Medical Center - Midtown Campus
Baltimore , Maryland
University of Maryland Medical Center
Baltimore , Maryland
Technical details
Status
Not yet recruiting
Phase
Phase 4
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
01.09.2026
Completion date
28.02.2028
Registry ID
NCT07537413
Source
clinicaltrials.gov
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