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

Not Applicable

Not yet recruiting

• Conditions: Severe Community-acquired Pneumonia (sCAP)
• Interventions: Drug: Piperacillin/Tazobactam; Drug: Piperacillin/tazobactam + Levofloxacin

• Registration Number: NCT06977347
• Lead Sponsor: CHOSEOK YOON

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-09
• Study First Submitted QC: 2025-05-09
• Last Update Submitted: 2025-05-09
• Study First Posted: 2025-05-18
• Last Update Posted: 2025-05-18
• Study Start: 2025-06-15
• Primary Completion: 2026-12-31
• Study Completion: 2027-02-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Piperacillin/Tazobactam Monotherapy	Piperacillin/Tazobactam	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.
Piperacillin/Tazobactam Plus Levofloxacin Combination Therapy	Piperacillin/tazobactam + Levofloxacin	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.

Primary Outcome Measures

Name	Time	Method
All-cause 28-day mortality	28 days	Mortality from any cause within 28 days of randomization.

Secondary Outcome Measures

Name	Time	Method
Need for mechanical ventilation	Up to hospital discharge or 28 days, whichever comes first	Proportion of patients requiring invasive mechanical ventilation during hospitalization.
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
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
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

Trial Locations

Locations (1)

Hanyang University Seoul Hospital; 🇰🇷 Seoul, Korea, Republic of