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

NCT06977347 | Not Yet Recruiting

• 1 other identifier: HYUH 2025-02-033-002
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Severe Community-acquired Pneumonia (sCAP)

Outcome Measures

Primary Outcomes (1)

• All-cause 28-day mortality

  Mortality from any cause within 28 days of randomization.

  28 days

Secondary Outcomes (6)

• Need for mechanical ventilation

  Up to hospital discharge or 28 days, whichever comes first

• ICU admission rate

  Up to hospital discharge or 28 days, whichever comes first

• Length of hospital stay

  Up to hospital discharge or 28 days, whichever comes first

• Time to fever resolution

  Up to 7 days after treatment initiation

• Antibiotic-related adverse events

  From first dose to 28 days post-treatment

Study Arms (2)

Piperacillin/Tazobactam Monotherapy

EXPERIMENTAL

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.

Drug: Piperacillin/Tazobactam

Piperacillin/Tazobactam Plus Levofloxacin Combination Therapy

ACTIVE COMPARATOR

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.

Drug: Piperacillin/tazobactam + Levofloxacin

Interventions

Piperacillin/Tazobactam DRUG

Piperacillin/tazobactam: 4.5g IV q6h (over 3h)

Piperacillin/Tazobactam Monotherapy

Piperacillin/tazobactam + Levofloxacin DRUG

Piperacillin/tazobactam: 4.5g IV q6h (over 3h) \+ Levofloxacin 750mg IV q24h (over 30min)

Piperacillin/Tazobactam Plus Levofloxacin Combination Therapy

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• CHOSEOK YOON: lead

Study Sites (1)

Hanyang University Seoul Hospital

Seoul, Seoul, 04761, South Korea

Location

MeSH Terms

Conditions

Community-Acquired Pneumonia

Interventions

Piperacillin, Tazobactam Drug Combination; Piperacillin; Tazobactam; Levofloxacin

Condition Hierarchy (Ancestors)

Community-Acquired Infections; Infections; Pneumonia; Respiratory Tract Infections; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Penicillanic Acid; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Ampicillin; Penicillin G; Sulfur Compounds; Sulfones; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Drug Combinations; Pharmaceutical Preparations; Ofloxacin; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines

Central Study Contacts

CHOSEOK YOON, MD

CONTACT

+821024893231; yooncho119@naver.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor, Division of Infectious Diseases, Department of Internal Medicine, Hanyang University Hospital, Seoul, South Korea

Study Record Dates

• First Submitted: May 9, 2025
• First Posted: May 18, 2025
• Study Start: June 15, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: May 18, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)