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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Piperacillin/tazobactam: 4.5g IV q6h (over 3h)
Piperacillin/tazobactam: 4.5g IV q6h (over 3h) \+ Levofloxacin 750mg IV q24h (over 30min)
Hanyang University Seoul Hospital
Seoul, Seoul, South Korea
All-cause 28-day mortality
Mortality from any cause within 28 days of randomization.
Time frame: 28 days
Need for mechanical ventilation
Proportion of patients requiring invasive mechanical ventilation during hospitalization.
Time frame: Up to hospital discharge or 28 days, whichever comes first
ICU admission rate
Proportion of patients who require admission to the intensive care unit (ICU) during hospitalization
Time frame: Up to hospital discharge or 28 days, whichever comes first
Length of hospital stay
Total number of days from admission to discharge
Time frame: Up to hospital discharge or 28 days, whichever comes first
Time to fever resolution
Time in days from initiation of antibiotic treatment to the first documented temperature \< 37.8°C maintained for at least 24 hours without antipyretic use
Time frame: Up to 7 days after treatment initiation
Antibiotic-related adverse events
Incidence of adverse drug reactions associated with study antibiotics (e.g., gastrointestinal symptoms, allergic reactions, hepatotoxicity, nephrotoxicity) as assessed by the treating physician
Time frame: From first dose to 28 days post-treatment
14-day hospital readmission rate
Proportion of patients who are readmitted to any hospital for any cause within 14 days after completion of antibiotic therapy
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Time frame: 14 days after end of antibiotic treatment