Appropriateness of Antibiotic Combination Therapy for Severe Community-acquired Pneumonia in South Korea

Официальное название

Verification of Anti-pseudomonal Antibiotic Combination Therapy in Severe Community-acquired Pneumonia in South Korea: A Randomized-controlled Study

Обзор

This study aims to provide high-level evidence for appropriate empirical antibiotic use tailored to the clinical reality in Korea by conducting a randomized controlled trial comparing monotherapy with piperacillin/tazobactam and combination therapy with piperacillin/tazobactam plus a fluoroquinolone in patients with severe community-acquired pneumonia.

Вмешательства

• Препарат Piperacillin/Tazobactam
  Piperacillin/tazobactam: 4.5g IV q6h (over 3h)
• Препарат Piperacillin/tazobactam + Levofloxacin
  Piperacillin/tazobactam: 4.5g IV q6h (over 3h) \+ Levofloxacin 750mg IV q24h (over 30min)

Первичные конечные точки

• All-cause 28-day mortality [Срок оценки: 28 days]

Вторичные конечные точки (6)

• Need for mechanical ventilation [Срок оценки: Up to hospital discharge or 28 days, whichever comes first]
• ICU admission rate [Срок оценки: Up to hospital discharge or 28 days, whichever comes first]
• Length of hospital stay [Срок оценки: Up to hospital discharge or 28 days, whichever comes first]
• Time to fever resolution [Срок оценки: Up to 7 days after treatment initiation]
• Antibiotic-related adverse events [Срок оценки: From first dose to 28 days post-treatment]
• 14-day hospital readmission rate [Срок оценки: 14 days after end of antibiotic treatment]

Критерии участия

• Inclusion Criteria:

• Adult patients aged 19 years or older who visited the emergency department and were hospitalized.
• Findings consistent with pneumonia diagnosis, meeting all of the following criteria:
• Radiologic evidence of pulmonary infiltration on chest X-ray or chest CT.
• At least two or more of the following clinical signs:

i) Body temperature ≥38°C or <36°C ii) White blood cell count ≥11,000/µL or <4,000/µL iii) Presence of purulent sputum or bronchial secretions

• Within 24 hours of admission, the patient meets one major criterion or three minor criteria according to ATS/IDSA classification:

• Major criteria:

i) Invasive mechanical ventilation ii) Use of vasopressors (vasopressor-dependent septic shock)

• Minor criteria:

i) Respiratory rate ≥30 breaths/min ii) PaO2/FiO2 ≤ 250 iii) Multilobar infiltrates iv) Confusion or disorientation v) BUN ≥20 mg/dL vi) WBC <4,000/mm³ vii) Platelet count <100,000/mm³ viii) Hypothermia (temperature <36°C) ix) Hypotension requiring aggressive fluid resuscitation

• Exclusion Criteria:

• Transferred from another hospital after >48 hours of hospitalization
• Died within 72 hours of hospital admission
• Transferred to another hospital within 14 days of admission
• Pneumonia occurring after >48 hours of mechanical ventilation, including home ventilators
• Detection of influenza or SARS-CoV-2 virus within 7 days of hospitalization
• Identified non-pneumonia infection requiring antibiotics within 72 hours of admission
• Detection of piperacillin/tazobactam-resistant Enterobacterales, Pseudomonas spp., or Acinetobacter spp. in respiratory or blood cultures within the past 90 days
• Antibiotic-related adverse events observed within 72 hours of assigned treatment, requiring discontinuation or change of antibiotics

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

South Korea · 1 центр

• Hanyang University Seoul Hospital — Seoul

Идентификаторы

NCT: NCT06977347 · HYUH 2025-02-033-002

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗