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)
Overview
- Phase
- Phase 2
- Intervention
- Levofloxacin 500 mg placebol
- Conditions
- Community-acquired Pneumonia
- Sponsor
- TaiGen Biotechnology Co., Ltd.
- Enrollment
- 192
- Locations
- 32
- Primary Endpoint
- Per subject clinical cure rate
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
Nemonoxacin 750 mg
Nemonoxacin 750 mg 2 tablets.
Intervention: Levofloxacin 500 mg placebol
Nemonoxacin 500 mg
Nemonoxacin 500 mg 3 tablets
Intervention: Levofloxacin 500 mg placebol
Levofloxacin 500 mg
Levofloxacin 500 mg
Intervention: Nemonoxacin 3 tablets
Outcomes
Primary Outcomes
Per subject clinical cure rate
Time Frame: 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
Time Frame: 16days
Microbiological cure rate equals to number of microbiological evaluable divided by number of eradicated or presumed eradicated.
Secondary Outcomes
- Pharmacokinetic profile of nemonoxacin in CAP subjects(3days)