Appropriateness of Antibiotic Combination Therapy for Severe Community-acquired Pneumonia in South Korea (ACTSCAP)

CHOSEOK YOON

Status: Not yet enrolling

Conditions: Severe Community-acquired Pneumonia (sCAP)

Treatments: Drug: Piperacillin/tazobactam + Levofloxacin; Drug: Piperacillin/Tazobactam

Study type: Interventional

Funder types: Other

Identifiers

NCT06977347

HYUH 2025-02-033-002

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Piperacillin/Tazobactam Monotherapy

Experimental group

Description:

Patients receive empirical treatment with piperacillin/tazobactam alone for severe community-acquired pneumonia. The antibiotic is administered according to standard dosing guidelines for hospitalized patients.

Treatment:

Drug: Piperacillin/Tazobactam

Piperacillin/Tazobactam Plus Levofloxacin Combination Therapy

Active Comparator group

Description:

Patients receive empirical combination treatment with piperacillin/tazobactam and levofloxacin for severe community-acquired pneumonia. Both antibiotics are administered concurrently according to institutional protocols for combination therapy.

Treatment:

Drug: Piperacillin/tazobactam + Levofloxacin