Severe Community-acquired Pneumonia (sCAP)
Conditions
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 piperacillin/tazobactam and combination therapy with piperacillin/tazobactam plus a fluoroquinolone in patients with severe community-acquired pneumonia.
Interventions
DRUGPiperacillin/Tazobactam
Piperacillin/tazobactam: 4.5g IV q6h (over 3h)
DRUGPiperacillin/tazobactam + Levofloxacin
Piperacillin/tazobactam: 4.5g IV q6h (over 3h) \+ Levofloxacin 750mg IV q24h (over 30min)
Sponsors
CHOSEOK YOON
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| All-cause 28-day mortality | 28 days | Mortality from any cause within 28 days of randomization. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ICU admission rate | Up to hospital discharge or 28 days, whichever comes first | Proportion of patients who require admission to the intensive care unit (ICU) during hospitalization |
| Length of hospital stay | Up to hospital discharge or 28 days, whichever comes first | Total number of days from admission to discharge |
| Need for mechanical ventilation | Up to hospital discharge or 28 days, whichever comes first | Proportion of patients requiring invasive mechanical ventilation during hospitalization. |
| Antibiotic-related adverse events | From first dose to 28 days post-treatment | Incidence of adverse drug reactions associated with study antibiotics (e.g., gastrointestinal symptoms, allergic reactions, hepatotoxicity, nephrotoxicity) as assessed by the treating physician |
| 14-day hospital readmission rate | 14 days after end of antibiotic treatment | Proportion of patients who are readmitted to any hospital for any cause within 14 days after completion of antibiotic therapy |
| Time to fever resolution | Up to 7 days after treatment initiation | 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 |
Countries
South Korea
Contacts
Primary ContactCHOSEOK YOON, MD
Outcome results
None listed