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

Sponsor
TaiGen Biotechnology Co., Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT01529476
Collaborator
Qualitix Clinical Research Co., Ltd. (Industry), Parexel (Industry), PPD (Industry)
540
Enrollment
57
Locations
2
Arms
20
Duration (Months)
9.5
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

  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 or Disease Intervention/Treatment Phase
Phase 3

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).

Study Design

Study Type:
Interventional
Actual Enrollment :
540 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (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)
Study Start Date :
Apr 1, 2011
Actual Primary Completion Date :
Aug 1, 2012
Actual Study Completion Date :
Dec 1, 2012

Arms and Interventions

Arm Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

  1. Per subject clinical cure rate [21days]

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

Secondary Outcome Measures

  1. Safety Evaluation [24days]

    Clinical adverse events and abnormal laboratory or other special test findings during this study should be observed and recorded carefully.

  2. Per subject microbiological cure rate [14 days]

    The microbiological cure rate will be evaluated according to the microbiological identification results of the central laboratory

  3. Per subject overall cure rate [14 days]

    Evaluate the overall efficacy after a comprehensive consideration of the clinical results and the bacteriological results.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Anzhen Hospital,Beijing Capital Medical University Anzhen China
2 Beijing Union Medical College Hospital Beijing China
3 General Hospital of PLA Second Artillery Beijing China
4 Beijing Chaoyang Hospital Chaoyang China
5 West China Hospital of Sichuan University,Center for Infection Disease Chengdu China
6 PLA Third Militrary Medical University,Second Affiliated Hospital Chongqing China
7 PLA Third Militrary Medical University,Third Affiliated Hospital Chongqing China
8 The First Affiliated Hospital,Chongqing Medical University Chongqing China
9 The First Hospital of Fujian Medical University Fuzhou China
10 People's Hospital of Gansu Province Gansu China
11 GuangZhou Red Cross Hospital GuangZhou China
12 Sun Yet-sen Memorial Hospital Guangzhou China
13 Affilated Hospital of Guilin Medical college Guilin China
14 Hainan Provincial People's Hospital Hainan China
15 Hospital Affiliated to Hainan Medical College Hainan China
16 Hubei General Hospital Hubei China
17 Taihe Hospital Hubei China
18 Hunan Provincial People's Hospital Hunan China
19 Third Xiangya Hospital,Central South University Hunan China
20 People's Hospital of Jiangxi Province Jiangxi China
21 Jinan Central Hospital Jinan China
22 Lanzhou university second hospital Lanzhou China
23 Shengjing Hospital of China Medical University Liaoning China
24 Second Affiliated Hospital of Nanchang University Nanchang China
25 Nanjing Genrak Hospital of Nanjing Millitary Command Nanjing China
26 Peking University First Hospital Peking China
27 Peking University People's Hospital Peking China
28 Huadong Hospital of Fudan University Shanghai China
29 Putuo Central Hospital Shanghai China
30 Shanghai Changzheng Hospital Shanghai China
31 Shanghai East Hospital in Pudong New Area Shanghai China
32 Shanghai Sixth People's Hospital Shanghai China
33 The First Hospital of Shanxi Medical College Shanxi China
34 PLA General Hospital of Shenyang Military Region Shenyang China
35 ShenZhen People's Hospital ShenZhen China
36 Institute of Antibiotics,Huashan Hospital ,Fudan University Shianghai China
37 Department of Resoiratory Medicine,West China Hospital of Sichuan University Sichuan China
38 Shuang Ho Hospital Taipei China
39 The Second Hospital of Wenzhou Medical College Wenzhou China
40 Wuhan General Hospital of Guangzhou Millitary Command Wuhan China
41 The First Affiliated Hospital,Xinjiang Medical University Xinjiang China
42 First Affiliated Hospital,Zhejiang University School of Medicine Zhejiang China
43 Chia-Yi Christian Hospital Chia-Yi Taiwan
44 E-Da Hospital Kaohsiung Taiwan
45 Kaohsiung hang Gung Memorial Hospital Kaohsiung Taiwan
46 Kaohsiung Medical University Chung-Ho Memorial Hospital Kaohsiung Taiwan
47 Yuan's General Hospital Kaohsiung Taiwan
48 ChiMei Medical Hospital-Liuying branch Liuying Taiwan
49 Cheng Ching General Hospital Taichung Taiwan
50 China Medical University Hospital Taichung Taiwan
51 Chung Shan Medical University Hospital Taichung Taiwan
52 Veterans General Hospital-TaiChung TaiChung Taiwan
53 Cheng Hsin General Hospital Taipei Taiwan
54 Far-East Memorial Hospital Taipei Taiwan
55 National Taiwan University Hospital Taipei Taiwan
56 Tri-Service General Hospital Taipei Taiwan
57 Veterans General Hospital-Taipei Taipei Taiwan

Sponsors and Collaborators

  • TaiGen Biotechnology Co., Ltd.
  • Qualitix Clinical Research Co., Ltd.
  • Parexel
  • PPD

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
TaiGen Biotechnology Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01529476
Other Study ID Numbers:
  • TG-873870-C-4
First Posted:
Feb 8, 2012
Last Update Posted:
Jun 18, 2013
Last Verified:
Jun 1, 2013
Keywords provided by TaiGen Biotechnology Co., Ltd.
Ofloxacin
Levofloxacin
Ofloxacin hydrochloride
Additional relevant MeSH terms:
Pneumonia
Levofloxacin
Ofloxacin

Study Results

No Results Posted as of Jun 18, 2013