Phase II Clinical Study to Assess the Efficacy and Safety of Nemonoxacin Malate in Treating Adult Patients With Community-acquired Pneumonia (CAP)

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.

Inclusion criteria

• age of 18~70, BMI ≥ 18 kg/m2
• Female patients must avoid pregnancy
• Patients who are clinically diagnosed with community-acquired pneumonia (CAP)
• Chest X-ray shows inflammatory exudation or infiltration image.
• Patients who used antibacterial agents (excluding quinolones) within 72 hours before
• The patient's disease condition permits oral administration

Exclusion criteria

• Patients who have any of bronchiectasis and pulmonary disease.
• Hospitalized within 14 days before enrollment
• Have a history of allergy to any quinolone or fluoroquinolone antibiotic
• Patients who suffered uncontrolled mental disorders, epilepsy or central nervous system diseases.
• Renal, liver insufficiency
• Malabsorption syndrome or other gastrointestinal diseases
• 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
• Steroids longterm use, the dose is at least 20mg of prednisone daily
• Patients under critical condition.
• Shows significant abnormality of the cardiac conduction system (CCS) or other abnormalities, or prolonged QTc
• Have a medical history of prolonged QTc, or require concomitant medication of drugs that will lead to prolongation of QTc
• Patients who received chemotherapy or anti-tumor therapy within 6 months
• Alcohol abused or drugs banned
• Patients who used quinolones within two weeks before enrollment
• Donated more than 500ml of blood within 3 months
• co-medication of other antibacterial agents required.
• by investigators judgement,patient who increase the risk to the subjects or interfere with this clinical trial.