Study to Evaluate the Efficacy and Safety of Oral Administration With Nemonoxacin and Levofloxacin in Patients With CAP
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)
1 other identifier
interventional
540
2 countries
57
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Apr 2011
57 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2011
CompletedFirst Submitted
Initial submission to the registry
January 31, 2012
CompletedFirst Posted
Study publicly available on registry
February 8, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedJune 18, 2013
June 1, 2013
1.3 years
January 31, 2012
June 17, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (3)
Safety Evaluation
24days
Per subject microbiological cure rate
14 days
Per subject overall cure rate
14 days
Study Arms (2)
Nemonoxacin 500 mg
EXPERIMENTALLevofloxacin 500 mg
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- TaiGen Biotechnology Co., Ltd.lead
- Qualitix Clinical Research Co., Ltd.collaborator
- Parexelcollaborator
- PPD Development, LPcollaborator
Study Sites (57)
Anzhen Hospital,Beijing Capital Medical University
Anzhen, China
Beijing Union Medical College Hospital
Beijing, China
General Hospital of PLA Second Artillery
Beijing, China
Peking University First Hospital
Beijing, China
Peking University People's Hospital
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
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, China
Chia-Yi Christian Hospital
Chiayi City, Taiwan
E-Da Hospital
Kaohsiung City, Taiwan
Kaohsiung hang Gung Memorial Hospital
Kaohsiung City, Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Taiwan
Yuan's General Hospital
Kaohsiung City, 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, Taiwan
Related Publications (1)
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.
PMID: 30181096DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 31, 2012
First Posted
February 8, 2012
Study Start
April 1, 2011
Primary Completion
August 1, 2012
Study Completion
December 1, 2012
Last Updated
June 18, 2013
Record last verified: 2013-06