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

Primary Purpose

Pneumonia

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Levofloxacin
Nemonoxacin
Sponsored by
TaiGen Biotechnology Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pneumonia focused on measuring Ofloxacin, Levofloxacin, Ofloxacin hydrochloride

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Ages between 18 and 70;
  2. Weighs between 40 ~ 100 kg, and BMI ≥ 18 kg/m2;
  3. Must have a clinical diagnosis of CAP
  4. Chest X-ray shows new or persist/progressive infiltrates
  5. If female, non-lactating and at no risk or pregnancy (post-menopausal or must use adequate birth control)
  6. The patient is able to take the drug orally.

Exclusion Criteria:

  1. 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
  2. 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)
  3. Clinically significant conduction or other abnormality on 12-lead ECG, or QTc interval
  4. Potassium is < 3.5 mmol/L
  5. Any known disease that seriously affect the immune system
  6. Active hepatitis or decompensated cirrhosis;
  7. Have used quinolones or fluoroquinolones within 14 days before enrollment
  8. Patients who are being or will be on a long-term medication of steroids

Sites / Locations

  • Anzhen Hospital,Beijing Capital Medical University
  • Beijing Union Medical College Hospital
  • General Hospital of PLA Second Artillery
  • Beijing Chaoyang Hospital
  • West China Hospital of Sichuan University,Center for Infection Disease
  • PLA Third Militrary Medical University,Second Affiliated Hospital
  • PLA Third Militrary Medical University,Third Affiliated Hospital
  • The First Affiliated Hospital,Chongqing Medical University
  • The First Hospital of Fujian Medical University
  • People's Hospital of Gansu Province
  • GuangZhou Red Cross Hospital
  • Sun Yet-sen Memorial Hospital
  • Affilated Hospital of Guilin Medical college
  • Hainan Provincial People's Hospital
  • Hospital Affiliated to Hainan Medical College
  • Hubei General Hospital
  • Taihe Hospital
  • Hunan Provincial People's Hospital
  • Third Xiangya Hospital,Central South University
  • People's Hospital of Jiangxi Province
  • Jinan Central Hospital
  • Lanzhou university second hospital
  • Shengjing Hospital of China Medical University
  • Second Affiliated Hospital of Nanchang University
  • Nanjing Genrak Hospital of Nanjing Millitary Command
  • Peking University First Hospital
  • Peking University People's Hospital
  • Huadong Hospital of Fudan University
  • Putuo Central Hospital
  • Shanghai Changzheng Hospital
  • Shanghai East Hospital in Pudong New Area
  • Shanghai Sixth People's Hospital
  • The First Hospital of Shanxi Medical College
  • PLA General Hospital of Shenyang Military Region
  • ShenZhen People's Hospital
  • Institute of Antibiotics,Huashan Hospital ,Fudan University
  • Department of Resoiratory Medicine,West China Hospital of Sichuan University
  • Shuang Ho Hospital
  • The Second Hospital of Wenzhou Medical College
  • Wuhan General Hospital of Guangzhou Millitary Command
  • The First Affiliated Hospital,Xinjiang Medical University
  • First Affiliated Hospital,Zhejiang University School of Medicine
  • Chia-Yi Christian Hospital
  • E-Da Hospital
  • Kaohsiung hang Gung Memorial Hospital
  • Kaohsiung Medical University Chung-Ho Memorial Hospital
  • Yuan's General Hospital
  • ChiMei Medical Hospital-Liuying branch
  • Cheng Ching General Hospital
  • China Medical University Hospital
  • Chung Shan Medical University Hospital
  • Veterans General Hospital-TaiChung
  • Cheng Hsin General Hospital
  • Far-East Memorial Hospital
  • National Taiwan University Hospital
  • Tri-Service General Hospital
  • Veterans General Hospital-Taipei

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Nemonoxacin 500 mg

Levofloxacin 500 mg

Arm Description

Outcomes

Primary Outcome Measures

Per subject clinical cure rate
The clinical cure rate will be evaluated according to signs and symptoms and changes in the chest X-ray.

Secondary Outcome Measures

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

Full Information

First Posted
January 31, 2012
Last Updated
June 17, 2013
Sponsor
TaiGen Biotechnology Co., Ltd.
Collaborators
Qualitix Clinical Research Co., Ltd., Parexel, PPD
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1. Study Identification

Unique Protocol Identification Number
NCT01529476
Brief Title
Study to Evaluate the Efficacy and Safety of Oral Administration With Nemonoxacin and Levofloxacin in Patients With CAP
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
TaiGen Biotechnology Co., Ltd.
Collaborators
Qualitix Clinical Research Co., Ltd., Parexel, PPD

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumonia
Keywords
Ofloxacin, Levofloxacin, Ofloxacin hydrochloride

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
540 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nemonoxacin 500 mg
Arm Type
Experimental
Arm Title
Levofloxacin 500 mg
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Levofloxacin
Intervention Description
levofloxacin 500 mg,QD,7~10 days
Intervention Type
Drug
Intervention Name(s)
Nemonoxacin
Intervention Description
Nemonoxacin 500mg,QD,7~10 days
Primary Outcome Measure Information:
Title
Per subject clinical cure rate
Description
The clinical cure rate will be evaluated according to signs and symptoms and changes in the chest X-ray.
Time Frame
21days
Secondary Outcome Measure Information:
Title
Safety Evaluation
Description
Clinical adverse events and abnormal laboratory or other special test findings during this study should be observed and recorded carefully.
Time Frame
24days
Title
Per subject microbiological cure rate
Description
The microbiological cure rate will be evaluated according to the microbiological identification results of the central laboratory
Time Frame
14 days
Title
Per subject overall cure rate
Description
Evaluate the overall efficacy after a comprehensive consideration of the clinical results and the bacteriological results.
Time Frame
14 days

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: 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
Facility Information:
Facility Name
Anzhen Hospital,Beijing Capital Medical University
City
Anzhen
Country
China
Facility Name
Beijing Union Medical College Hospital
City
Beijing
Country
China
Facility Name
General Hospital of PLA Second Artillery
City
Beijing
Country
China
Facility Name
Beijing Chaoyang Hospital
City
Chaoyang
Country
China
Facility Name
West China Hospital of Sichuan University,Center for Infection Disease
City
Chengdu
Country
China
Facility Name
PLA Third Militrary Medical University,Second Affiliated Hospital
City
Chongqing
Country
China
Facility Name
PLA Third Militrary Medical University,Third Affiliated Hospital
City
Chongqing
Country
China
Facility Name
The First Affiliated Hospital,Chongqing Medical University
City
Chongqing
Country
China
Facility Name
The First Hospital of Fujian Medical University
City
Fuzhou
Country
China
Facility Name
People's Hospital of Gansu Province
City
Gansu
Country
China
Facility Name
GuangZhou Red Cross Hospital
City
GuangZhou
Country
China
Facility Name
Sun Yet-sen Memorial Hospital
City
Guangzhou
Country
China
Facility Name
Affilated Hospital of Guilin Medical college
City
Guilin
Country
China
Facility Name
Hainan Provincial People's Hospital
City
Hainan
Country
China
Facility Name
Hospital Affiliated to Hainan Medical College
City
Hainan
Country
China
Facility Name
Hubei General Hospital
City
Hubei
Country
China
Facility Name
Taihe Hospital
City
Hubei
Country
China
Facility Name
Hunan Provincial People's Hospital
City
Hunan
Country
China
Facility Name
Third Xiangya Hospital,Central South University
City
Hunan
Country
China
Facility Name
People's Hospital of Jiangxi Province
City
Jiangxi
Country
China
Facility Name
Jinan Central Hospital
City
Jinan
Country
China
Facility Name
Lanzhou university second hospital
City
Lanzhou
Country
China
Facility Name
Shengjing Hospital of China Medical University
City
Liaoning
Country
China
Facility Name
Second Affiliated Hospital of Nanchang University
City
Nanchang
Country
China
Facility Name
Nanjing Genrak Hospital of Nanjing Millitary Command
City
Nanjing
Country
China
Facility Name
Peking University First Hospital
City
Peking
Country
China
Facility Name
Peking University People's Hospital
City
Peking
Country
China
Facility Name
Huadong Hospital of Fudan University
City
Shanghai
Country
China
Facility Name
Putuo Central Hospital
City
Shanghai
Country
China
Facility Name
Shanghai Changzheng Hospital
City
Shanghai
Country
China
Facility Name
Shanghai East Hospital in Pudong New Area
City
Shanghai
Country
China
Facility Name
Shanghai Sixth People's Hospital
City
Shanghai
Country
China
Facility Name
The First Hospital of Shanxi Medical College
City
Shanxi
Country
China
Facility Name
PLA General Hospital of Shenyang Military Region
City
Shenyang
Country
China
Facility Name
ShenZhen People's Hospital
City
ShenZhen
Country
China
Facility Name
Institute of Antibiotics,Huashan Hospital ,Fudan University
City
Shianghai
Country
China
Facility Name
Department of Resoiratory Medicine,West China Hospital of Sichuan University
City
Sichuan
Country
China
Facility Name
Shuang Ho Hospital
City
Taipei
Country
China
Facility Name
The Second Hospital of Wenzhou Medical College
City
Wenzhou
Country
China
Facility Name
Wuhan General Hospital of Guangzhou Millitary Command
City
Wuhan
Country
China
Facility Name
The First Affiliated Hospital,Xinjiang Medical University
City
Xinjiang
Country
China
Facility Name
First Affiliated Hospital,Zhejiang University School of Medicine
City
Zhejiang
Country
China
Facility Name
Chia-Yi Christian Hospital
City
Chia-Yi
Country
Taiwan
Facility Name
E-Da Hospital
City
Kaohsiung
Country
Taiwan
Facility Name
Kaohsiung hang Gung Memorial Hospital
City
Kaohsiung
Country
Taiwan
Facility Name
Kaohsiung Medical University Chung-Ho Memorial Hospital
City
Kaohsiung
Country
Taiwan
Facility Name
Yuan's General Hospital
City
Kaohsiung
Country
Taiwan
Facility Name
ChiMei Medical Hospital-Liuying branch
City
Liuying
Country
Taiwan
Facility Name
Cheng Ching General Hospital
City
Taichung
Country
Taiwan
Facility Name
China Medical University Hospital
City
Taichung
Country
Taiwan
Facility Name
Chung Shan Medical University Hospital
City
Taichung
Country
Taiwan
Facility Name
Veterans General Hospital-TaiChung
City
TaiChung
Country
Taiwan
Facility Name
Cheng Hsin General Hospital
City
Taipei
Country
Taiwan
Facility Name
Far-East Memorial Hospital
City
Taipei
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei
Country
Taiwan
Facility Name
Tri-Service General Hospital
City
Taipei
Country
Taiwan
Facility Name
Veterans General Hospital-Taipei
City
Taipei
Country
Taiwan

12. IPD Sharing Statement

Citations:
PubMed Identifier
30181096
Citation
Yuan J, Mo B, Ma Z, Lv Y, Cheng SL, Yang Y, Tong Z, Wu R, Sun S, Cao Z, Wu J, Zhu D, Chang L, Zhang Y; Investigator Group of the Phase 3 Study on Oral Nemonoxacin. Safety and efficacy of oral nemonoxacin versus levofloxacin in treatment of community-acquired pneumonia: A phase 3, multicenter, randomized, double-blind, double-dummy, active-controlled, non-inferiority trial. J Microbiol Immunol Infect. 2019 Feb;52(1):35-44. doi: 10.1016/j.jmii.2017.07.011. Epub 2017 Aug 2.
Results Reference
derived

Learn more about this trial

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

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