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

Pneumonia Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01529476
• Other study ID #: TG-873870-C-4
• Status: Completed
• Phase: Phase 3
• First received: January 31, 2012
• Last updated: June 17, 2013
• Start date: April 2011
• Est. completion date: December 2012

Study information

• Verified date: June 2013
• Source: TaiGen Biotechnology Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 540
• Est. completion date: December 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Pneumonia

Intervention

Drug:
• Levofloxacin
levofloxacin 500 mg,QD,7~10 days
• Nemonoxacin
Nemonoxacin 500mg,QD,7~10 days

Locations

Country	Name	City	State
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	PLA Third Militrary Medical University,Second Affiliated Hospital	Chongqing
China	PLA Third Militrary Medical University,Third Affiliated Hospital	Chongqing
China	The First Affiliated Hospital,Chongqing Medical University	Chongqing
China	The First Hospital of Fujian Medical University	Fuzhou
China	People's Hospital of Gansu Province	Gansu
China	GuangZhou Red Cross Hospital	GuangZhou
China	Sun Yet-sen Memorial Hospital	Guangzhou
China	Affilated Hospital of Guilin Medical college	Guilin
China	Hainan Provincial People's Hospital	Hainan
China	Hospital Affiliated to Hainan Medical College	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	Huadong Hospital of Fudan University	Shanghai
China	Putuo Central Hospital	Shanghai
China	Shanghai Changzheng Hospital	Shanghai
China	Shanghai East Hospital in Pudong New Area	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
Taiwan	Chia-Yi Christian Hospital	Chia-Yi
Taiwan	E-Da Hospital	Kaohsiung
Taiwan	Kaohsiung hang Gung Memorial Hospital	Kaohsiung
Taiwan	Kaohsiung Medical University Chung-Ho Memorial Hospital	Kaohsiung
Taiwan	Yuan's General 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	Cheng Hsin General Hospital	Taipei
Taiwan	Far-East Memorial Hospital	Taipei
Taiwan	National Taiwan University Hospital	Taipei
Taiwan	Tri-Service General Hospital	Taipei
Taiwan	Veterans General Hospital-Taipei	Taipei

Sponsors (4)

Lead Sponsor	Collaborator
TaiGen Biotechnology Co., Ltd.	Parexel, PPD, Qualitix Clinical Research Co., Ltd.

Countries where clinical trial is conducted

China,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Per subject clinical cure rate	The clinical cure rate will be evaluated according to signs and symptoms and changes in the chest X-ray.	21days	Yes
Secondary	Safety Evaluation	Clinical adverse events and abnormal laboratory or other special test findings during this study should be observed and recorded carefully.	24days	Yes
Secondary	Per subject microbiological cure rate	The microbiological cure rate will be evaluated according to the microbiological identification results of the central laboratory	14 days	No
Secondary	Per subject overall cure rate	Evaluate the overall efficacy after a comprehensive consideration of the clinical results and the bacteriological results.	14 days	Yes