Appropriateness of Antibiotic Combination Therapy for Severe Community-acquired Pneumonia in Sout… (NCT06977347) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Appropriateness of Antibiotic Combination Therapy for Severe Community-acquired Pneumonia in South Korea
South Korea100 participantsStarted 2025-06-15
Plain-language 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 piperacillin/tazobactam and combination therapy with piperacillin/tazobactam plus a fluoroquinolone in patients with severe community-acquired pneumonia.
Who can participate
Age range19 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
* 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 requir…