NIPH Clinical Trials Search

Open-label Randomized Controlled Study of LSFX Switch Therapy vs. SBT/ABPC in OldEr Patients with Pneumonia

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Community-acquired pneumonia
Date of first enrollment	26/11/2025
Target sample size	160
Countries of recruitment
Study type	Interventional
Intervention(s)	Lascufloxacin Switch Therapy Group Lascufloxacin is initially administered by intravenous infusion at a dose of 300 mg. From the second dose onward, 150 mg is administered once daily via intravenous infusion over a period of 60 minutes. If the criteria for clinical stability are met between Day 3 and Day 5 after the initiation of intravenous administration, the formulation is switched to oral lascufloxacin tablets. The total duration of administration is, in principle, seven consecutive days.Lascufloxacin tablets are administered orally once daily. Ampicillin/sulbactam intravenous group Ampicillin/sulbactam is administered intravenously at a dose of 3 g per infusion, three times daily, with each infusion lasting 60 minutes. The total duration of administration is, in principle, seven consecutive days.

Outcome(s)

Primary Outcome

The clinical cure rate at the time of test-of-cure (TOC) in study participants treated with either lascufloxacin switch therapy (switching from 150 mg intravenous infusion to 75 mg oral tablets) or standard therapy with ampicillin/sulbactam intravenous infusion.

Secondary Outcome

1. Proportion of patients who underwent switching from intravenous to oral lascufloxacin, and the time required to meet the switching criteria 2. Clinical outcomes at the time of early clinical assessment and at end of treatment (EOT) 3. Length of hospital stay (both actual length of stay and time until discharge criteria are met) 4. Medical costs 5. All-cause mortality within 30 days after EOT, mortality beyond 30 days after EOT, and new onset of pneumonia 6. Time to achieve clinical stabilization criteria 7. Microbiological efficacy

Key inclusion & exclusion criteria

Age minimum	>= 65age old
Age maximum	Not applicable
Gender	Both
Include criteria	(1) Patients aged 65 years or older (regardless of gender) (2) Patients with newly identified opacities on chest X-ray or chest CT images within 48 hours prior to the start of investigational drug administration (3) Patients who meet both of the following conditions 1) At least one of the following clinical symptoms a. Cough b. Purulent sputum or worsening purulence of sputum c. Abnormal findings on auscultation or percussion (crackles, dullness on percussion, diminished breath sounds, etc.) d. Worsening dyspnea or tachypnea e. Fever: >=37 Celsius degrees (axillary temperature) 2) At least one of the following laboratory findings a. Positive C-reactive protein b. Increased white blood cell count (leukocytes >10,000/mm3) or stab cells >15% c. Hypoxemia (PaO2 < 60 Torr or SpO2 < 90%) (4) Patients deemed to require intravenous antimicrobials on admission (5) Patients with mild or moderate community-onset pneumonia according to the A-DROP system (6) Patients with a score of 1 or more on the Simplified Fraility Index (7) Patients (or their legally authorized representatives) who have obtained written informed consent to participate in the study
Exclude criteria	(1) Patients with a history of hypersensitivity to quinolone antibacterial agents (2) Patients with QT prolongation (QTc>=500ms) (3) Patients with hypokalemia (K<3.5mEq/L) (4) Patients receiving Class IA (quinidine, procainamide, etc.) or Class III (amiodarone, sotalol, etc.) antiarrhythmic drugs (5) Patients with severe hepatic dysfunction (Child-Pugh Grade B) (6) Patients with complications or past history of convulsive disorder such as epilepsy (7) Patients with arrhythmia such as severe bradycardia, ischemic heart disease, heart failure or other cardiac disease (8) Patients with myasthenia gravis (9) Patients with aortic aneurysm or aortic dissection, history of aortic aneurysm or aortic dissection, family history or risk factors (e.g. Marfan syndrome) (10) Patients with infectious mononucleosis (11) Patients with severe renal impairment (eGFR or creatinine clearance < 30 mL/min/1.73 m2) (12) Patients with a history of recurrent aspiration pneumonia (13) Patients certified as requiring long-term care or considered equivalent (14) Patients with white blood cell count less than 2,000/mm3 (15) Patients receiving systemic administration of other antimicrobial agents within 7 days prior to administration of the investigational agent (excluding long-term low-dose macrolides and prophylactic use of trimethoprim-sulfamethoxazole) (16) Patients with respiratory infections caused by pathogens (e.g., mycobacteria, fungi, viruses) that are unlikely to respond to the investigational drug (17) Patients with immunosuppressive conditions (e.g., patients receiving immunosuppressive or systemic steroid drugs, patients undergoing cancer chemotherapy, patients suffering from an immunosuppressive disease) (18) Patients with severe or progressive underlying diseases or complications (e.g., poorly controlled diabetes patients with HbA1c >8.0%, advanced cancer patients with no life expectancy during the observation period, advanced cancer patients requiring surgery) (19) Patients with bronchial obstruction or a history of obstructive pneumonia (excluding patients with chronic obstructive pulmonary disease) (20) Patients with active tuberculosis (including suspected cases), or those with the following diseases that prevent accurate assessment of pneumonia: primary lung cancer, malignant tumors with pulmonary metastasis, eosinophilic pneumonia, interstitial pneumonia, or cystic fibrosis (21) Patients with active hepatitis B or hepatitis C or HIV infection (22) Patients with a history of hypersensitivity to penicillin antimicrobial agents (23) Patients currently participating in clinical trials or other interventional studies (24) Patients deemed inappropriate for participation in this study by the principal investigator or sub-investigators