Pneumonia
Conditions
Keywords
Ofloxacin, Levofloxacin, Ofloxacin hydrochloride
Brief summary
1. This study will test the safety and efficacy of TG-873870 (Nemonoxacin) compared with Levofloxacin in adult patients with Community-Aquired Pneumonia (CAP) 2. To investigate the population pharmacokinetics (PPK) of nemonoxacin in adult patients with CAP after continuous oral administration and determine the pharmacokinetic (PK)/pharmacodynamic (PD).
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 test the safety and efficacy of TG-873870 (Nemonoxacin) compared with Levofloxacin in adult patients with Community-Aquired Pneumonia (CAP). Besides,the population pharmacokinetics (PPK) of nemonoxacin in adult patients with CAP after continuous oral administration and determine the pharmacokinetic (PK)/pharmacodynamic (PD).
Interventions
DRUGLevofloxacin
levofloxacin 500 mg,QD,7\ 10 days
DRUGNemonoxacin
Nemonoxacin 500mg,QD,7\ 10 days
Sponsors
Qualitix Clinical Research Co., Ltd.
Parexel
PPD Development, LP
TaiGen Biotechnology Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Ages between 18 and 70; 2. Weighs between 40 \ 100 kg, and BMI ≥ 18 kg/m2; 3. Must have a clinical diagnosis of CAP 4. Chest X-ray shows new or persist/progressive infiltrates 5. If female, non-lactating and at no risk or pregnancy (post-menopausal or must use adequate birth control) 6. The patient is able to take the drug orally.
Exclusion criteria
1. Patients with CAP that, in the investigator's judgment, is severe enough to require hospitalization for intravenous antibiotic therapy and/or supplemental oxygen therapy with ICU support 2. Known or suspected severe bronchiectasis, cystic fibrosis, active pulmonary tuberculosis or infection with other mycobacteria or fungi, known bronchial obstruction, a history of post-obstructive pneumonia, other confounding respiratory diseases, such as lung cancer, malignancy metastatic to the lungs, lung abscess, empyema, suspected aspiration pneumonia due to vomiting, or non-bacterial respiratory infection (chronic obstructive pulmonary disease \[COPD\] is not exclusionary) 3. Clinically significant conduction or other abnormality on 12-lead ECG, or QTc interval 4. Potassium is \< 3.5 mmol/L 5. Any known disease that seriously affect the immune system 6. Active hepatitis or decompensated cirrhosis; 7. Have used quinolones or fluoroquinolones within 14 days before enrollment 8. Patients who are being or will be on a long-term medication of steroids
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Per subject clinical cure rate | 21days | 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 | 14 days | The microbiological cure rate will be evaluated according to the microbiological identification results of the central laboratory |
| Per subject overall cure rate | 14 days | Evaluate the overall efficacy after a comprehensive consideration of the clinical results and the bacteriological results. |
| Safety Evaluation | 24days | Clinical adverse events and abnormal laboratory or other special test findings during this study should be observed and recorded carefully. |
Countries
China, Taiwan
Outcome results
None listed