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

NCT ID: NCT06977347

Last Updated: 2025-05-18

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-15
• Study Completion Date: 2027-02-01

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)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Piperacillin/Tazobactam Monotherapy

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.

Group Type: EXPERIMENTAL

Piperacillin/Tazobactam

Intervention Type: DRUG

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

Piperacillin/Tazobactam Plus Levofloxacin Combination Therapy

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.

Group Type: ACTIVE_COMPARATOR

Piperacillin/tazobactam + Levofloxacin

Intervention Type: DRUG

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

+ Levofloxacin 750mg IV q24h (over 30min)

Interventions

Piperacillin/Tazobactam

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

Intervention Type: DRUG

Piperacillin/tazobactam + Levofloxacin

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

+ Levofloxacin 750mg IV q24h (over 30min)

Intervention Type: DRUG

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CHOSEOK YOON

OTHER

Sponsor Role: lead

Responsible Party

CHOSEOK YOON

Clinical Professor, Division of Infectious Diseases, Department of Internal Medicine, Hanyang University Hospital, Seoul, South Korea

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Hanyang University Seoul Hospital

Seoul, Seoul, South Korea

Countries

South Korea

Central Contacts

CHOSEOK YOON, MD

Role: CONTACT

yooncho119@naver.com

+821024893231

Facility Contacts

CHOSEOK YOON

Role: primary

yooncho119@naver.com

+821024893231

Other Identifiers

HYUH 2025-02-033-002

Identifier Type: -

Identifier Source: org_study_id