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Search / Trial NCT06977347

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

Launched by CHOSEOK YOON · May 9, 2025

Trial Information

Current as of July 23, 2025

Not yet recruiting

Keywords

ClinConnect Summary

This clinical trial is studying the best way to treat severe community-acquired pneumonia (sCAP) in South Korea, which is a serious lung infection that people can get outside of hospitals. The researchers want to find out if using just one antibiotic called piperacillin/tazobactam works as well as using it in combination with another antibiotic from the fluoroquinolone group. By comparing these two treatment methods, the trial aims to help doctors provide the most effective care for patients with this condition.

To participate in this trial, you need to be an adult, at least 19 years old, and have been hospitalized with pneumonia. This means you should have signs of infection in your lungs, such as a high fever or increased white blood cell count, and specific symptoms like difficulty breathing. The trial is not yet recruiting participants, but if you qualify, you can expect to be randomly assigned to one of the two treatment groups. It’s important to note that certain health conditions, like being transferred from another hospital or having certain infections, may exclude you from joining. The goal is to improve treatment for patients with severe pneumonia, making it a valuable opportunity for those who are eligible.

Gender

ALL

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

About Choseok Yoon

Choseok Yoon is a dedicated clinical trial sponsor with a focus on advancing medical research through innovative methodologies and collaborative partnerships. With a commitment to ethical standards and patient safety, Yoon oversees the design, implementation, and management of clinical studies aimed at evaluating new treatments and therapies. Leveraging a wealth of expertise in clinical operations and regulatory compliance, Yoon ensures that trials are conducted efficiently and in alignment with industry best practices, ultimately contributing to the development of effective healthcare solutions.

Locations

Seoul, , Korea, Republic Of

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported