Hanyang University Seoul Hospital
Seoul, 04761, South Korea
NCT Number: NCT06977347
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.
Trial opening soon.
Get Notified19 year and older
All sexes
Interventional
Not applicable
Seoul, 04761, South Korea
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
i) Invasive mechanical ventilation ii) Use of vasopressors (vasopressor-dependent septic shock)
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
Piperacillin/tazobactam: 4.5g IV q6h (over 3h)
Piperacillin/tazobactam: 4.5g IV q6h (over 3h)
+ Levofloxacin 750mg IV q24h (over 30min)
Time frame: 28 days
Mortality from any cause within 28 days of randomization.
Time frame: Up to hospital discharge or 28 days, whichever comes first
Proportion of patients requiring invasive mechanical ventilation during hospitalization.
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
Time frame: Up to hospital discharge or 28 days, whichever comes first
Total number of days from admission to discharge
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
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
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
Contact information is provided by the study sponsor or research team.
CHOSEOK YOON
Other
Verification of Anti-pseudomonal Antibiotic Combination Therapy in Severe Community-acquired Pneumonia in South Korea: A Randomized-controlled Study
Acronym: ACTSCAP
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.
Published trials that share one or more normalized conditions with this study.
NCT07301099
Community-Acquired Infections, Community-Acquired Pneumonia
Chía, Colombia
View Trial DetailsNCT07152587
Community-Acquired Infections, Community-Acquired Pneumonia
View Trial DetailsNCT07070284
Community-Acquired Infections, Community-Acquired Pneumonia
Zagreb, City of Zagreb, Croatia
View Trial DetailsNCT07726095
Community-Acquired Infections, Community-Acquired Pneumonia
Zhengzhou, Henan, China
View Trial Details