Study to Evaluate the Efficacy and Safety of Oral Administration With Nemonoxacin and Levofloxacin in Patients With CAP

Study Overview
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Brief Summary
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This study will test the safety and efficacy of TG-873870 (Nemonoxacin) compared with Levofloxacin in adult patients with Community-Aquired Pneumonia (CAP) 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
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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).

Official Title
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A Randomized, Double-Blind, Comparative, Multi-Center Study of the Safety and Efficacy of TG-873870(Nemonoxacin) Versus Levofloxacin in Adult Patients With Community-Acquired Pneumonia (CAP)

Conditions
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Pneumonia

Intervention / Treatment
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* Drug: Levofloxacin
* Drug: Nemonoxacin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ages between 18 and 70; Weighs between 40   100 kg, and BMI ≥ 18 kg/m2; Must have a clinical diagnosis of CAP Chest X-ray shows new or persist/progressive infiltrates If female, non-lactating and at no risk or pregnancy (post-menopausal or must use adequate birth control) The patient is able to take the drug orally. Exclusion Criteria: 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 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) Clinically significant conduction or other abnormality on 12-lead ECG, or QTc interval Potassium is < 3.5 mmol/L Any known disease that seriously affect the immune system Active hepatitis or decompensated cirrhosis; Have used quinolones or fluoroquinolones within 14 days before enrollment Patients who are being or will be on a long-term medication of steroids

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nemonoxacin 500 mg<br> | Drug: Nemonoxacin<br>* Nemonoxacin 500mg,QD,7 10 days<br>|
| Active Comparator: Levofloxacin 500 mg<br> | Drug: Levofloxacin<br>* levofloxacin 500 mg,QD,7 10 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Per subject clinical cure rate | The clinical cure rate will be evaluated according to signs and symptoms and changes in the chest X-ray. | 21days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety Evaluation | Clinical adverse events and abnormal laboratory or other special test findings during this study should be observed and recorded carefully. | 24days | 
| Per subject microbiological cure rate | The microbiological cure rate will be evaluated according to the microbiological identification results of the central laboratory | 14 days | 
| Per subject overall cure rate | Evaluate the overall efficacy after a comprehensive consideration of the clinical results and the bacteriological results. | 14 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ofloxacin, Levofloxacin, Ofloxacin hydrochloride