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. 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).

Study Overview

• Status: Completed
• Conditions: Pneumonia
• Intervention / Treatment: Drug: Nemonoxacin; Drug: Levofloxacin

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 Type: Interventional
• Enrollment (Actual): 540
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Anzhen, China
    • Anzhen Hospital,Beijing Capital Medical University
  • Beijing, China
    • Beijing Union Medical College Hospital
  • Beijing, China
    • General Hospital of PLA Second Artillery
  • Chaoyang, China
    • Beijing ChaoYang Hospital
  • Chengdu, China
    • West China Hospital of Sichuan University,Center for Infection Disease
  • Chongqing, 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
  • Fuzhou, China
    • The First Hospital of Fujian Medical University
  • Gansu, China
    • People's Hospital of Gansu Province
  • GuangZhou, China
    • Guangzhou red cross hospital
  • Guangzhou, China
    • Sun Yet-sen Memorial Hospital
  • Guilin, China
    • Affilated Hospital of Guilin Medical college
  • Hainan, China
    • Hainan Provincial People's Hospital
  • Hainan, China
    • Hospital Affiliated to Hainan Medical College
  • Hubei, China
    • Hubei General Hospital
  • Hubei, China
    • Taihe Hospital
  • Hunan, China
    • Hunan Provincial People's Hospital
  • Hunan, China
    • Third Xiangya Hospital,Central South University
  • Jiangxi, China
    • People's Hospital of Jiangxi province
  • Jinan, China
    • Jinan Central Hospital
  • Lanzhou, China
    • Lanzhou University Second Hospital
  • Liaoning, China
    • Shengjing Hospital of China Medical University
  • Nanchang, China
    • Second Affiliated Hospital of Nanchang University
  • Nanjing, China
    • Nanjing Genrak Hospital of Nanjing Millitary Command
  • Peking, China
    • Peking University People's Hospital
  • Peking, China
    • Peking University First Hospital
  • Shanghai, China
    • Shanghai Changzheng Hospital
  • Shanghai, China
    • Shanghai Sixth People's Hospital
  • Shanghai, China
    • Huadong Hospital of Fudan University
  • Shanghai, China
    • Putuo Central Hospital
  • Shanghai, China
    • Shanghai East Hospital in Pudong New Area
  • Shanxi, China
    • The First Hospital of Shanxi Medical College
  • ShenZhen, China
    • Shenzhen People's Hospital
  • Shenyang, China
    • PLA General Hospital of Shenyang Military Region
  • Shianghai, China
    • Institute of Antibiotics,Huashan Hospital ,Fudan University
  • Sichuan, China
    • Department of Resoiratory Medicine,West China Hospital of Sichuan University
  • Taipei, China
    • Shuang Ho Hospital
  • Wenzhou, China
    • The Second Hospital of Wenzhou Medical College
  • Wuhan, China
    • Wuhan General Hospital of Guangzhou Millitary Command
  • Xinjiang, China
    • The First Affiliated Hospital,Xinjiang Medical University
  • Zhejiang, China
    • First Affiliated Hospital,Zhejiang University School of Medicine
• Taiwan
  • Chia-Yi, Taiwan
    • Chia-Yi Christian Hospital
  • Kaohsiung, Taiwan
    • Kaohsiung Medical University Chung-Ho Memorial Hospital
  • Kaohsiung, Taiwan
    • E-DA hospital
  • Kaohsiung, Taiwan
    • Kaohsiung hang Gung Memorial Hospital
  • Kaohsiung, Taiwan
    • Yuan's General Hospital
  • Liuying, Taiwan
    • ChiMei Medical Hospital-Liuying branch
  • TaiChung, Taiwan
    • Veterans General Hospital-Taichung
  • Taichung, Taiwan
    • China Medical University Hospital
  • Taichung, Taiwan
    • Cheng Ching General Hospital
  • Taichung, Taiwan
    • Chung Shan Medical University Hospital
  • Taipei, Taiwan
    • Tri-Service General Hospital
  • Taipei, Taiwan
    • National Taiwan University Hospital
  • Taipei, Taiwan
    • Veterans General Hospital-Taipei
  • Taipei, Taiwan
    • Cheng Hsin General Hospital
  • Taipei, Taiwan
    • Far-East Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety Evaluation	Clinical adverse events and abnormal laboratory or other special test findings during this study should be observed and recorded carefully.	24days
Per subject microbiological cure rate	The microbiological cure rate will be evaluated according to the microbiological identification results of the central laboratory	14 days
Per subject overall cure rate	Evaluate the overall efficacy after a comprehensive consideration of the clinical results and the bacteriological results.	14 days

Collaborators and Investigators

• Sponsor: TaiGen Biotechnology Co., Ltd.
• Collaborators: PPD; Parexel; Qualitix Clinical Research Co., Ltd.

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2011
• Primary Completion (ACTUAL): August 1, 2012
• Study Completion (ACTUAL): December 1, 2012

Study Registration Dates

• First Submitted: January 31, 2012
• First Submitted That Met QC Criteria: February 6, 2012
• First Posted (ESTIMATE): February 8, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): June 18, 2013
• Last Update Submitted That Met QC Criteria: June 17, 2013
• Last Verified: June 1, 2013

More Information

Terms related to this study

• Keywords: Levofloxacin; Ofloxacin; Ofloxacin hydrochloride
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Pneumonia; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Anti-Bacterial Agents; Cytochrome P-450 Enzyme Inhibitors; Cytochrome P-450 CYP1A2 Inhibitors; Anti-Infective Agents, Urinary; Renal Agents; Levofloxacin; Ofloxacin
• Other Study ID Numbers: TG-873870-C-4