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NCT Number: NCT06977347

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

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.

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hanyang University Seoul Hospital

Seoul, 04761, South Korea

Location contact

BONGYOUNG KIM, MD, PHD

PRINCIPAL_INVESTIGATOR

CHOSEOK YOON

CONTACT

[email protected]

+821024893231

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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

Treatment and study plan

Piperacillin/tazobactam

Drug

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

Piperacillin/tazobactam + Levofloxacin

Drug

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

+ Levofloxacin 750mg IV q24h (over 30min)

Primary outcomes

  1. All-cause 28-day mortality

    Time frame: 28 days

    Mortality from any cause within 28 days of randomization.

Secondary outcomes

  1. Need for mechanical ventilation

    Time frame: Up to hospital discharge or 28 days, whichever comes first

    Proportion of patients requiring invasive mechanical ventilation during hospitalization.

  2. ICU admission rate

    Time frame: Up to hospital discharge or 28 days, whichever comes first

    Proportion of patients who require admission to the intensive care unit (ICU) during hospitalization

  3. Length of hospital stay

    Time frame: Up to hospital discharge or 28 days, whichever comes first

    Total number of days from admission to discharge

  4. Time to fever resolution

    Time frame: 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

  5. Antibiotic-related adverse events

    Time frame: 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

  6. 14-day hospital readmission rate

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

CHOSEOK YOON, MD

CONTACT

[email protected]

+821024893231

Sponsors and collaborators

Lead sponsor

CHOSEOK YOON

Other

Registry information

Official study title

Verification of Anti-pseudomonal Antibiotic Combination Therapy in Severe Community-acquired Pneumonia in South Korea: A Randomized-controlled Study

Acronym: ACTSCAP

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
May 18, 2025
Registry last updated
May 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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