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

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Multi-center, Randomized, Double-blind, Double-dummy Parallel-controlled Phase II Clinical Study to Assess the Efficacy and Safety of Nemonoxacin Malate in Treating Adult Patients With Community-acquired Pneumonia (CAP)

Conditions
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Community-acquired Pneumonia

Intervention / Treatment
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* Drug: Levofloxacin 500 mg placebol
* Drug: Levofloxacin 500 mg placebol
* Drug: Nemonoxacin 3 tablets


Participation Criteria
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Eligibility Criteria
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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.

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Nemonoxacin 750 mg<br>Nemonoxacin 750 mg 2 tablets. | Drug: Levofloxacin 500 mg placebol<br>* oral form,,once adily,7 10 days<br>|
| Active Comparator: Nemonoxacin 500 mg<br>Nemonoxacin 500 mg 3 tablets | Drug: Levofloxacin 500 mg placebol<br>* oral form,,once adily,7 10 days<br>|
| Active Comparator: Levofloxacin 500 mg<br>Levofloxacin 500 mg | Drug: Nemonoxacin 3 tablets<br>* oral form,once daily,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 | 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. | 16days | 
| Per subject microbiological cure rate | Microbiological cure rate equals to number of microbiological evaluable divided by number of eradicated or presumed eradicated. | 16days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic profile of nemonoxacin in CAP subjects |  | 3days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CAP