Status:
NOT_YET_RECRUITING
Appropriateness of Antibiotic Combination Therapy for Severe Community-acquired Pneumonia in South Korea
Lead Sponsor:
CHOSEOK YOON
Conditions:
Severe Community-acquired Pneumonia (sCAP)
Eligibility:
All Genders
19+ years
Phase:
NA
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2027
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06977347
Start Date
June 15 2025
End Date
February 1 2027
Last Update
May 18 2025
Active Locations (1)
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1
Hanyang University Seoul Hospital
Seoul, Seoul, South Korea, 04761