Community-acquired Pneumonia
Conditions
Keywords
intravenous nemonoxacin, community-acquired pneumonia
Brief summary
The purpose of this study is to evaluate the efficacy, safety and pharmacokinetics of intravenous nemonoxacin compared with intravenous moxifloxacin in adult patients with community-acquired pneumonia (CAP).
Detailed description
Community-acquired Pneumonia (CAP) remains a leading cause of death in both developing and developed countries. In the choice of antibacterial agents used to treat CAP, fluoroquinolones have received considerable attention because of their wide spectrum of bactericidal activity. TG-873870 (Nemonoxacin), a non-fluorinated quinolone (NFQ), is a selective bacterial topoisomerase inhibitor. This study will evaluate the clinical efficacy, microbiological efficacy and safety of Intravenous nemonoxacin compared with Intravenous levofloxacin in adult patients with community-acquired pneumonia. Besides, the populationpharmacokinetics (PPK) of nemonoxacin in adult patients with CAP after continuous IV Infusion and the pharmacokinetic (PK)/pharmacodynamic (PD)are to be determined.
Interventions
DRUGNemonoxacin
DRUGLevofloxacin
Sponsors
TaiGen Biotechnology Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Ages between 18 and 80; 2. Weighs between 40 \ 100 kg, and BMI ≥ 18 kg/m2; 3. Must have a clinical diagnosis of CAP 4. Chest X-ray and /or CT scan show new or persist/progressive infiltrates 5. Patients with PORT/PSI score II, III or IV. 6. If female, non-lactating and at no risk or pregnancy (post-menopausal or must use adequate birth control) 7. Male must use a reliable form of contraception. 8. Able to receive an intravenous infusion of the drug 9. Able to provide an adequate sputum and blood samples 10. Able to provide written informed consent
Exclusion criteria
1. Patients with PORT/PSI score I or VI. 2. Severe CAP is present if a patient needs invasive mechanical ventilation or requires vasopressors. 3. Healthcare-associated pneumonia, hospital-acquired pneumonia, or hospitalized within 14 days before enrollment 4. Virus pneumonia, aspiration pneumonia, ventilator associated pneumonia, or intersstitial lung disease 5. Bronchial bostruction (exclusive of COPD), bronchiectasis, cystic fibrosis, known or suspected pneumocystis pneumonia, known or suspected tuberculosis, primary empyema thoracis, lung abscess, known or suspected lung cancer, or lung disease associated with autoimmune disorders. 6. Medical history of QT prolongation, require the treatment of arrhythmia using class IA or class III drugs, or NYHA functional class \>/= III 7. Clinically significant findings on 12-lead ECG, QTc interval\>450ms or potassium is \< 3.5 mmol/L or lower limit of normal at Screening 8. Immunocompromising illness, such as HIV infection 9. Fatal progressive disease or neurodegenerative diseases that prevent patients from effectively clearing pulmonary secretions 10. Have medical history of seizure, alcohol or drug abuse, suicide tendency, or psychosis that can effect the compliance 11. Have diseases that may affect intravenous infusion. 12. Active hepatitis or decompensated cirrhosis with ascites (Child-Pugh score 10-15/class C); 13. Renal Insufficiency or creatinine \>/= 1.1 ULN within 24 hr before first dose 14. ALT or AST \>/= 3x ULN, or BUN \>/= 30 mg/dL within 24 hr before first dose 15. Neutrophil \< 1000 mm3 within 24 hr before first dose 16. Received systemic antibiotics within 72 hr before first dose 17. Received probenecid within 24 hr before first dose or require the treatment with probenecid during study 18. Received quinolones or fluoroquinolones within 14 days before first dose 19. Received any investigational drugs within 30 days before first dose 20. Require the treatment with other systemic antibiotics during study 21. Patients who are being or will be on a long-term medication (over 2 weeks) of steroids (20mg/day) 22. Medical history of hypersensitivity to any quinolone, fluoroquinolone-associated tendinitis and tendon rupture, or myasthenia gravis 23. Current condition or abnormality that, in the opinion of the investigator, would compromise the safety of the subject or the quality of the data 24. Participated and received the study medication in previous clinical trials
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Per subject clinical cure rate | end of treatment and 7 to 14 days after the end of treatment | The clinical cure rate will be evaluated according to signs and symptoms and changes in the chest X-ray |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Per subject microbiological cure rate | end of treatment and 7 to 14 days after the end of treatment | The microbiological cure rate will be evaluated according to the microbiological identification results of the central laboratory |
| Per subject overall cure rate | end of treatment and 7 to 14 days after the end of treatment | Evaluate the overall efficacy after a comprehensive consideration of the clinical results and the bacteriological results. |
| Safety evaluation | duration of trial | Incidence and severity of AE and changes in safety parameters from baseline |
Countries
China, Taiwan
Outcome results
None listed