Appropriateness of Antibiotic Combination Therapy for Severe Community-acquired Pneumonia in Sout… (NCT06977347) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Appropriateness of Antibiotic Combination Therapy for Severe Community-acquired Pneumonia in South Korea
South Korea100 participantsStarted 2025-06-15
Plain-language 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.
Who can participate
Age range
19 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
* 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 requir…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.