Community-acquired Pneumonia
Conditions
Keywords
CAP
Brief summary
The purpose of this study is to evaluate the safety, tolerability and population pharmacokinetics of oral nemonoxacin in community-acquired pneumonia (CAP) subjects.
Detailed description
Evaluate clinical efficacy, microbiological efficacy and safety of Nemonoxacin adult patients with community-acquired pneumonia (CAP); and A study on the population pharmacokinetics (PPK) of continuous oral administration of Nemonoxacin in adult patients with CAP.
Interventions
DRUGLevofloxacin 500 mg placebol
oral form,,once adily,7\ 10 days
DRUGNemonoxacin 3 tablets
oral form,once daily,7\ 10 days
Sponsors
TaiGen Biotechnology Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. age of 18\ 70, BMI ≥ 18 kg/m2 2. Female patients must avoid pregnancy 3. Patients who are clinically diagnosed with community-acquired pneumonia (CAP) 4. Chest X-ray shows inflammatory exudation or infiltration image. 5. Patients who used antibacterial agents (excluding quinolones) within 72 hours before 6. The patient's disease condition permits oral administration
Exclusion criteria
1. Patients who have any of bronchiectasis and pulmonary disease. 2. Hospitalized within 14 days before enrollment 3. Have a history of allergy to any quinolone or fluoroquinolone antibiotic 4. Patients who suffered uncontrolled mental disorders, epilepsy or central nervous system diseases. 5. Renal, liver insufficiency 6. Malabsorption syndrome or other gastrointestinal diseases 7. Immune system diseases,such as a history of human immunodeficiency virus (HIV) infection,neutropenia or malignant tumor in the blood system or a solid organ, or removal of spleen 8. Steroids longterm use, the dose is at least 20mg of prednisone daily 9. Patients under critical condition. 10. Shows significant abnormality of the cardiac conduction system (CCS) or other abnormalities, or prolonged QTc 11. Have a medical history of prolonged QTc, or require concomitant medication of drugs that will lead to prolongation of QTc 12. Patients who received chemotherapy or anti-tumor therapy within 6 months 13. Alcohol abused or drugs banned 14. Patients who used quinolones within two weeks before enrollment 15. Donated more than 500ml of blood within 3 months 16. co-medication of other antibacterial agents required. 17. by investigators judgement,patient who increase the risk to the subjects or interfere with this clinical trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Per subject clinical cure rate | 16days | Clinical cure rate equals to number of clinical evaluable divided by number of clinical cured. If subject's clnical outcome is evaluable by principal invastigator, he/she is defined as clinical evaluable. |
| Per subject microbiological cure rate | 16days | Microbiological cure rate equals to number of microbiological evaluable divided by number of eradicated or presumed eradicated. |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic profile of nemonoxacin in CAP subjects | 3days |
Countries
China
Outcome results
None listed