Clinical trial NCT01529476: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pneumonia
Keywords: Ofloxacin
Levofloxacin
Ofloxacin hydrochloride
Lead sponsor: TaiGen Biotechnology Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Qualitix Clinical Research Co., Ltd.
name: Parexel
name: PPD Development, LP
First posted: 2012-02-08
Enrollment: 540
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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 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

Primary outcomes:
measure: Per subject clinical cure rate
timeFrame: 21days
Secondary outcomes:
measure: Safety Evaluation
timeFrame: 24days
measure: Per subject microbiological cure rate
timeFrame: 14 days
measure: Per subject overall cure rate
timeFrame: 14 days
Other outcomes:
Locations:
city: Anzhen
country: China
facility: Anzhen Hospital,Beijing Capital Medical University
city: Beijing
country: China
facility: Beijing Union Medical College Hospital
city: Beijing
country: China
facility: General Hospital of PLA Second Artillery
city: Chaoyang
country: China
facility: Beijing Chaoyang Hospital
city: Chengdu
country: China
facility: West China Hospital of Sichuan University,Center for Infection Disease
city: Chongqing
country: China
facility: PLA Third Militrary Medical University,Second Affiliated Hospital
city: Chongqing
country: China
facility: PLA Third Militrary Medical University,Third Affiliated Hospital
city: Chongqing
country: China
facility: The First Affiliated Hospital,Chongqing Medical University
city: Fuzhou
country: China
facility: The First Hospital of Fujian Medical University
city: Gansu
country: China
facility: People's Hospital of Gansu Province
city: GuangZhou
country: China
facility: GuangZhou Red Cross Hospital
city: Guangzhou
country: China
facility: Sun Yet-sen Memorial Hospital
city: Guilin
country: China
facility: Affilated Hospital of Guilin Medical college
city: Hainan
country: China
facility: Hainan Provincial People's Hospital
city: Hainan
country: China
facility: Hospital Affiliated to Hainan Medical College
city: Hubei
country: China
facility: Hubei General Hospital
city: Hubei
country: China
facility: Taihe Hospital
city: Hunan
country: China
facility: Hunan Provincial People's Hospital
city: Hunan
country: China
facility: Third Xiangya Hospital,Central South University
city: Jiangxi
country: China
facility: People's Hospital of Jiangxi Province
city: Jinan
country: China
facility: Jinan Central Hospital
city: Lanzhou
country: China
facility: Lanzhou university second hospital
city: Liaoning
country: China
facility: Shengjing Hospital of China Medical University
city: Nanchang
country: China
facility: Second Affiliated Hospital of Nanchang University
city: Nanjing
country: China
facility: Nanjing Genrak Hospital of Nanjing Millitary Command
city: Peking
country: China
facility: Peking University First Hospital
city: Peking
country: China
facility: Peking University People's Hospital
city: Shanghai
country: China
facility: Huadong Hospital of Fudan University
city: Shanghai
country: China
facility: Putuo Central Hospital
city: Shanghai
country: China
facility: Shanghai Changzheng Hospital
city: Shanghai
country: China
facility: Shanghai East Hospital in Pudong New Area
city: Shanghai
country: China
facility: Shanghai Sixth People's Hospital
city: Shanxi
country: China
facility: The First Hospital of Shanxi Medical College
city: Shenyang
country: China
facility: PLA General Hospital of Shenyang Military Region
city: ShenZhen
country: China
facility: ShenZhen People's Hospital
city: Shianghai
country: China
facility: Institute of Antibiotics,Huashan Hospital ,Fudan University
city: Sichuan
country: China
facility: Department of Resoiratory Medicine,West China Hospital of Sichuan University
city: Taipei
country: China
facility: Shuang Ho Hospital
city: Wenzhou
country: China
facility: The Second Hospital of Wenzhou Medical College
city: Wuhan
country: China
facility: Wuhan General Hospital of Guangzhou Millitary Command
city: Xinjiang
country: China
facility: The First Affiliated Hospital,Xinjiang Medical University
city: Zhejiang
country: China
facility: First Affiliated Hospital,Zhejiang University School of Medicine
city: Chia-Yi
country: Taiwan
facility: Chia-Yi Christian Hospital
city: Kaohsiung
country: Taiwan
facility: E-Da Hospital
city: Kaohsiung
country: Taiwan
facility: Kaohsiung hang Gung Memorial Hospital
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital
city: Kaohsiung
country: Taiwan
facility: Yuan's General Hospital
city: Liuying
country: Taiwan
facility: ChiMei Medical Hospital-Liuying branch
city: Taichung
country: Taiwan
facility: Cheng Ching General Hospital
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Taichung
country: Taiwan
facility: Chung Shan Medical University Hospital
city: TaiChung
country: Taiwan
facility: Veterans General Hospital-TaiChung
city: Taipei
country: Taiwan
facility: Cheng Hsin General Hospital
city: Taipei
country: Taiwan
facility: Far-East Memorial Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Tri-Service General Hospital
city: Taipei
country: Taiwan
facility: Veterans General Hospital-Taipei
Study officials:
References:
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.