Ceftriaxone Dosage for Non-Critical Community-Acquired Pneumonia

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• Clinical cure [Срок оценки: The outcome will be assessed 120 days after enrollment]

Вторичные конечные точки (11)

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

Критерии участия

Критерии включения

• Evaluated in the emergency department or within 72 hours of hospitalization
• Prescribed Ceftriaxone for community-acquired pneumonia

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 2 центра

• University of Maryland Medical Center - Midtown Campus — Baltimore
• University of Maryland Medical Center — Baltimore

Идентификаторы

NCT: NCT07537413 · HP-00117776

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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