Back to resultsPhase II Clinical Study to Assess the Efficacy and Safety of Nemonoxacin Malate in Treating Adult Patients With Community-acquired Pneumonia (CAP)
Primary Purpose
Community-acquired Pneumonia
Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Levofloxacin 500 mg placebol
Levofloxacin 500 mg placebol
Nemonoxacin 3 tablets
Sponsored by
About this trial
This is an interventional treatment trial for Community-acquired Pneumonia focused on measuring CAP
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
- 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.
Sites / Locations
- Beijing Chaoyang Hospital, Capital Medical University
- Beijing Union Medical College Hospital, Chinese Academy of Medical Sciences
- Peking University First Hospital
- Peking University People's Hospital
- PLA Second Artillery General Hospital
- Zhen Hospital, Capital Medical University Beijing
- Daping Hospital, Third Military Medical University
- First Affiliated Hospital of Fujian Medical University
- Gansu Provincial People's Hospital
- Guangzhou Red Cross Hospital
- Second Affiliated Hospital of Sun Yat-sen
- Affiliated Hospital of Guilin Medical College
- Taihe Hospital in Shiyan City, Hubei Province
- Third Xiangya Hospital, Central South University
- Jiangxi Provincial People's Hospital
- Second Affiliated Hospital of Nanchang University
- Jinan Central Hospital
- Shengjing Hospital of China Medical University
- Nanjing General Hospital of Nanjing Military Region
- Institute of Antibiotics,Huashan Hospital ,Fudan University
- Huashan Hospital ,Fudan University
- Institute of Antibiotics, Huashan Hospital, Fundan University
- Shanghai Pudong New Area, Oriental Hospital
- Shanghai Putuo District Central Hospital
- First Hospital of Shanxi Medical University
- People's Liberation Army General Hospital of Shenyang Military Region
- Shenzhen People's Hospital
- West China Hospital of Sichuan University (Respiratory)
- Second Affiliated Hospital of Wenzhou Medical College
- People's Hospital of Wuhan University
- Wuhan General Hospital of PLA Guangzhou Military Region
- First Affiliated Hospital, Zhejiang University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Nemonoxacin 750 mg
Nemonoxacin 500 mg
Levofloxacin 500 mg
Arm Description
Nemonoxacin 750 mg 2 tablets.
Nemonoxacin 500 mg 3 tablets
Levofloxacin 500 mg
Outcomes
Primary Outcome Measures
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.
Per subject microbiological cure rate
Microbiological cure rate equals to number of microbiological evaluable divided by number of eradicated or presumed eradicated.
Secondary Outcome Measures
Pharmacokinetic profile of nemonoxacin in CAP subjects
Full Information
NCT ID
NCT01537250
First Posted
February 5, 2012
Last Updated
January 23, 2018
Sponsor
TaiGen Biotechnology Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT01537250
Brief Title
Phase II Clinical Study to Assess the Efficacy and Safety of Nemonoxacin Malate in Treating Adult Patients With Community-acquired Pneumonia (CAP)
Official Title
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)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
August 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
TaiGen Biotechnology Co., Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Community-acquired Pneumonia
Keywords
CAP
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
192 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nemonoxacin 750 mg
Arm Type
Active Comparator
Arm Description
Nemonoxacin 750 mg 2 tablets.
Arm Title
Nemonoxacin 500 mg
Arm Type
Active Comparator
Arm Description
Nemonoxacin 500 mg 3 tablets
Arm Title
Levofloxacin 500 mg
Arm Type
Active Comparator
Arm Description
Levofloxacin 500 mg
Intervention Type
Drug
Intervention Name(s)
Levofloxacin 500 mg placebol
Intervention Description
oral form,,once adily,7~10 days
Intervention Type
Drug
Intervention Name(s)
Levofloxacin 500 mg placebol
Intervention Description
oral form,,once adily,7~10 days
Intervention Type
Drug
Intervention Name(s)
Nemonoxacin 3 tablets
Intervention Description
oral form,once daily,7~10 days
Primary Outcome Measure Information:
Title
Per subject clinical cure rate
Description
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.
Time Frame
16days
Title
Per subject microbiological cure rate
Description
Microbiological cure rate equals to number of microbiological evaluable divided by number of eradicated or presumed eradicated.
Time Frame
16days
Secondary Outcome Measure Information:
Title
Pharmacokinetic profile of nemonoxacin in CAP subjects
Time Frame
3days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yingyuan Zhang, PhD
Organizational Affiliation
Huashan Hospital, Fundan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Chaoyang Hospital, Capital Medical University
City
Beijing
Country
China
Facility Name
Beijing Union Medical College Hospital, Chinese Academy of Medical Sciences
City
Beijing
Country
China
Facility Name
Peking University First Hospital
City
Beijing
Country
China
Facility Name
Peking University People's Hospital
City
Beijing
Country
China
Facility Name
PLA Second Artillery General Hospital
City
Beijing
Country
China
Facility Name
Zhen Hospital, Capital Medical University Beijing
City
Beijing
Country
China
Facility Name
Daping Hospital, Third Military Medical University
City
Chongqing
Country
China
Facility Name
First Affiliated Hospital of Fujian Medical University
City
Fujian
Country
China
Facility Name
Gansu Provincial People's Hospital
City
Gansu
Country
China
Facility Name
Guangzhou Red Cross Hospital
City
Guangzhou
Country
China
Facility Name
Second Affiliated Hospital of Sun Yat-sen
City
Guangzhou
Country
China
Facility Name
Affiliated Hospital of Guilin Medical College
City
Guilin
Country
China
Facility Name
Taihe Hospital in Shiyan City, Hubei Province
City
Hubei
Country
China
Facility Name
Third Xiangya Hospital, Central South University
City
Hunan
Country
China
Facility Name
Jiangxi Provincial People's Hospital
City
Jiangxi
Country
China
Facility Name
Second Affiliated Hospital of Nanchang University
City
Jiangxi
Country
China
Facility Name
Jinan Central Hospital
City
Jinan
Country
China
Facility Name
Shengjing Hospital of China Medical University
City
Liaoning
Country
China
Facility Name
Nanjing General Hospital of Nanjing Military Region
City
Nanjing
Country
China
Facility Name
Institute of Antibiotics,Huashan Hospital ,Fudan University
City
Shanghai,
Country
China
Facility Name
Huashan Hospital ,Fudan University
City
Shanghai
Country
China
Facility Name
Institute of Antibiotics, Huashan Hospital, Fundan University
City
Shanghai
Country
China
Facility Name
Shanghai Pudong New Area, Oriental Hospital
City
Shanghai
Country
China
Facility Name
Shanghai Putuo District Central Hospital
City
Shanghai
Country
China
Facility Name
First Hospital of Shanxi Medical University
City
Shanxi
Country
China
Facility Name
People's Liberation Army General Hospital of Shenyang Military Region
City
Shenyang
Country
China
Facility Name
Shenzhen People's Hospital
City
ShenZhen
Country
China
Facility Name
West China Hospital of Sichuan University (Respiratory)
City
Sichuan
Country
China
Facility Name
Second Affiliated Hospital of Wenzhou Medical College
City
Wenzhou
Country
China
Facility Name
People's Hospital of Wuhan University
City
Wuhan
Country
China
Facility Name
Wuhan General Hospital of PLA Guangzhou Military Region
City
Wuhan
Country
China
Facility Name
First Affiliated Hospital, Zhejiang University School of Medicine
City
Zhejiang
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
26748734
Citation
Liu Y, Zhang Y, Wu J, Zhu D, Sun S, Zhao L, Wang X, Liu H, Ren Z, Wang C, Xiu Q, Xiao Z, Cao Z, Cui S, Yang H, Liang Y, Chen P, Lv Y, Hu C, Lv X, Liu S, Kuang J, Li J, Wang D, Chang L. A randomized, double-blind, multicenter Phase II study comparing the efficacy and safety of oral nemonoxacin with oral levofloxacin in the treatment of community-acquired pneumonia. J Microbiol Immunol Infect. 2017 Dec;50(6):811-820. doi: 10.1016/j.jmii.2015.09.005. Epub 2015 Dec 1.
Results Reference
derived
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Phase II Clinical Study to Assess the Efficacy and Safety of Nemonoxacin Malate in Treating Adult Patients With Community-acquired Pneumonia (CAP)
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