Community-acquired pneumonia
Conditions
Interventions
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
Sponsors
Takazono Takahiro
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion 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
Exclusion criteria
Exclusion criteria: (1) Patients with a history of hypersensitivity to quinolone antibacterial agents (2) Patients with QT prolongation (QTc>=500ms) (3) Patients with hypokalemia (K8.0%, 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Contacts
Public ContactKazuaki Takeda
Nagasaki University Hospital
Outcome results
None listed