Phase II Clinical Study to Assess the Efficacy and Safety of Nemonoxacin Malate in Treating Adult Patients With Community-acquired Pneumonia (CAP)

A Multi-center, Randomized, Double-blind, Double-dummy Parallel-controlled Phase II Clinical Study to Assess the Efficacy and Safety of Nemonoxacin Malate in Treating Adult Patients With Community-acquired Pneumonia (CAP)

The purpose of this study is to evaluate the safety, tolerability and population pharmacokinetics of oral nemonoxacin in community-acquired pneumonia (CAP) subjects.

Study Overview

• Status: Completed
• Conditions: Community-acquired Pneumonia
• Intervention / Treatment: Drug: Levofloxacin 500 mg placebol; Drug: Nemonoxacin 3 tablets

Detailed Description

Evaluate clinical efficacy, microbiological efficacy and safety of Nemonoxacin adult patients with community-acquired pneumonia (CAP); and

A study on the population pharmacokinetics (PPK) of continuous oral administration of Nemonoxacin in adult patients with CAP.

• Study Type: Interventional
• Enrollment (Actual): 192
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Peking University First Hospital
  • Beijing, China
    • Peking University People's Hospital
  • Beijing, China
    • Zhen Hospital, Capital Medical University Beijing
  • Beijing, China
    • Beijing Chaoyang Hospital, Capital Medical University
  • Beijing, China
    • Beijing Union Medical College Hospital, Chinese Academy of Medical Sciences
  • Beijing, China
    • PLA Second Artillery General Hospital
  • Chongqing, China
    • Daping Hospital, Third Military Medical University
  • Fujian, China
    • First Affiliated Hospital of Fujian Medical University
  • Gansu, China
    • Gansu Provincial People's Hospital
  • Guangzhou, China
    • Guangzhou Red Cross Hospital
  • Guangzhou, China
    • Second Affiliated Hospital of Sun Yat-sen
  • Guilin, China
    • Affiliated Hospital of Guilin Medical College
  • Hubei, China
    • Taihe Hospital in Shiyan City, Hubei Province
  • Hunan, China
    • Third Xiangya Hospital, Central South University
  • Jiangxi, China
    • Jiangxi Provincial People's Hospital
  • Jiangxi, China
    • Second Affiliated Hospital of Nanchang University
  • Jinan, China
    • Jinan Central Hospital
  • Liaoning, China
    • Shengjing Hospital of China Medical University
  • Nanjing, China
    • Nanjing General Hospital of Nanjing Military Region
  • Shanghai, China
    • Institute of Antibiotics, Huashan Hospital, Fundan University
  • Shanghai, China
    • Shanghai Pudong New Area, Oriental Hospital
  • Shanghai, China
    • Huashan Hospital ,Fudan University
  • Shanghai, China
    • Shanghai Putuo District Central Hospital
  • Shanghai,, China
    • Institute of Antibiotics,Huashan Hospital ,Fudan University
  • Shanxi, China
    • First Hospital of Shanxi Medical University
  • ShenZhen, China
    • Shenzhen People's Hospital
  • Shenyang, China
    • People's Liberation Army General Hospital of Shenyang Military Region
  • Sichuan, China
    • West China Hospital of Sichuan University (Respiratory)
  • Wenzhou, China
    • Second Affiliated Hospital of Wenzhou Medical College
  • Wuhan, China
    • People's Hospital of Wuhan University
  • Wuhan, China
    • Wuhan General Hospital of PLA Guangzhou Military Region
  • Zhejiang, China
    • First Affiliated Hospital, Zhejiang University School of Medicine

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. age of 18~70, BMI ≥ 18 kg/m2
2. Female patients must avoid pregnancy
3. Patients who are clinically diagnosed with community-acquired pneumonia (CAP)
4. Chest X-ray shows inflammatory exudation or infiltration image.
5. Patients who used antibacterial agents (excluding quinolones) within 72 hours before
6. The patient's disease condition permits oral administration

Exclusion Criteria:

1. Patients who have any of bronchiectasis and pulmonary disease.
2. Hospitalized within 14 days before enrollment
3. Have a history of allergy to any quinolone or fluoroquinolone antibiotic
4. Patients who suffered uncontrolled mental disorders, epilepsy or central nervous system diseases.
5. Renal, liver insufficiency
6. Malabsorption syndrome or other gastrointestinal diseases
7. Immune system diseases,such as a history of human immunodeficiency virus (HIV) infection,neutropenia or malignant tumor in the blood system or a solid organ, or removal of spleen
8. Steroids longterm use, the dose is at least 20mg of prednisone daily
9. Patients under critical condition.
10. Shows significant abnormality of the cardiac conduction system (CCS) or other abnormalities, or prolonged QTc
11. Have a medical history of prolonged QTc, or require concomitant medication of drugs that will lead to prolongation of QTc
12. Patients who received chemotherapy or anti-tumor therapy within 6 months
13. Alcohol abused or drugs banned
14. Patients who used quinolones within two weeks before enrollment
15. Donated more than 500ml of blood within 3 months
16. co-medication of other antibacterial agents required.
17. by investigators judgement,patient who increase the risk to the subjects or interfere with this clinical trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Nemonoxacin 750 mg; Nemonoxacin 750 mg 2 tablets.	Drug: Levofloxacin 500 mg placebol; oral form,,once adily,7~10 days
Active Comparator: Nemonoxacin 500 mg; Nemonoxacin 500 mg 3 tablets	Drug: Levofloxacin 500 mg placebol; oral form,,once adily,7~10 days
Active Comparator: Levofloxacin 500 mg	Drug: Nemonoxacin 3 tablets; oral form,once daily,7~10 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Per subject clinical cure rate	Clinical cure rate equals to number of clinical evaluable divided by number of clinical cured. If subject's clnical outcome is evaluable by principal invastigator, he/she is defined as clinical evaluable.	16days
Per subject microbiological cure rate	Microbiological cure rate equals to number of microbiological evaluable divided by number of eradicated or presumed eradicated.	16days

Secondary Outcome Measures

Outcome Measure	Time Frame
Pharmacokinetic profile of nemonoxacin in CAP subjects	3days

Collaborators and Investigators

• Sponsor: TaiGen Biotechnology Co., Ltd.

Publications and helpful links

General Publications

• Liu Y, Zhang Y, Wu J, Zhu D, Sun S, Zhao L, Wang X, Liu H, Ren Z, Wang C, Xiu Q, Xiao Z, Cao Z, Cui S, Yang H, Liang Y, Chen P, Lv Y, Hu C, Lv X, Liu S, Kuang J, Li J, Wang D, Chang L. A randomized, double-blind, multicenter Phase II study comparing the efficacy and safety of oral nemonoxacin with oral levofloxacin in the treatment of community-acquired pneumonia. J Microbiol Immunol Infect. 2017 Dec;50(6):811-820. doi: 10.1016/j.jmii.2015.09.005. Epub 2015 Dec 1.

Study record dates

Study Major Dates

• Study Start: August 1, 2009
• Primary Completion (Actual): August 1, 2010
• Study Completion (Actual): August 1, 2010

Study Registration Dates

• First Submitted: February 5, 2012
• First Submitted That Met QC Criteria: February 16, 2012
• First Posted (Estimate): February 23, 2012

Study Record Updates

• Last Update Posted (Actual): January 24, 2018
• Last Update Submitted That Met QC Criteria: January 23, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: CAP
• 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-3