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

This study has been completed.
Sponsor:
Collaborators:
Qualitix Clinical Research Co., Ltd.
Parexel
PPD
Information provided by (Responsible Party):
TaiGen Biotechnology Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01529476
First received: January 31, 2012
Last updated: June 17, 2013
Last verified: June 2013
  Purpose
  1. This study will test the safety and efficacy of TG-873870 (Nemonoxacin) compared with Levofloxacin in adult patients with Community-Aquired Pneumonia (CAP)
  2. To investigate the population pharmacokinetics (PPK) of nemonoxacin in adult patients with CAP after continuous oral administration and determine the pharmacokinetic (PK)/pharmacodynamic (PD).

Condition Intervention Phase
Pneumonia
Drug: Levofloxacin
Drug: Nemonoxacin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by TaiGen Biotechnology Co., Ltd.:

Primary Outcome Measures:
  • Per subject clinical cure rate [ Time Frame: 21days ] [ Designated as safety issue: Yes ]
    The clinical cure rate will be evaluated according to signs and symptoms and changes in the chest X-ray.


Secondary Outcome Measures:
  • Safety Evaluation [ Time Frame: 24days ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    The microbiological cure rate will be evaluated according to the microbiological identification results of the central laboratory

  • Per subject overall cure rate [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
    Evaluate the overall efficacy after a comprehensive consideration of the clinical results and the bacteriological results.


Enrollment: 540
Study Start Date: April 2011
Study Completion Date: December 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Nemonoxacin 500 mg Drug: Nemonoxacin
Nemonoxacin 500mg,QD,7~10 days
Active Comparator: Levofloxacin 500 mg Drug: Levofloxacin
levofloxacin 500 mg,QD,7~10 days

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).

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01529476

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

No publications provided

Responsible Party: TaiGen Biotechnology Co., Ltd.
ClinicalTrials.gov Identifier: NCT01529476     History of Changes
Other Study ID Numbers: TG-873870-C-4
Study First Received: January 31, 2012
Last Updated: June 17, 2013
Health Authority: China: Food and Drug Administration

Keywords provided by TaiGen Biotechnology Co., Ltd.:
Ofloxacin
Levofloxacin
Ofloxacin hydrochloride

Additional relevant MeSH terms:
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Ofloxacin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Urinary
Renal Agents

ClinicalTrials.gov processed this record on July 26, 2014