Clinical trial NCT06977347: Appropriateness of Antibiotic Combination Therapy for Severe Community-acquired Pneumonia in South Korea
Official title: Verification of Anti-pseudomonal Antibiotic Combination Therapy in Severe Community-acquired Pneumonia in South Korea: A Randomized-controlled Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Severe Community-acquired Pneumonia (sCAP)
Lead sponsor: Seoul Hospital
Sponsor class: OTHER
First posted: 2025-05-18
Enrollment: 100
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: All-cause 28-day mortality
timeFrame: 28 days
Secondary outcomes:
measure: Need for mechanical ventilation
timeFrame: Up to hospital discharge or 28 days, whichever comes first
measure: ICU admission rate
timeFrame: Up to hospital discharge or 28 days, whichever comes first
measure: Length of hospital stay
timeFrame: Up to hospital discharge or 28 days, whichever comes first
measure: Time to fever resolution
timeFrame: Up to 7 days after treatment initiation
measure: Antibiotic-related adverse events
timeFrame: From first dose to 28 days post-treatment
measure: 14-day hospital readmission rate
timeFrame: 14 days after end of antibiotic treatment
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Hanyang University Seoul Hospital
Study officials:
References: