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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01537250
Recruitment Status : Completed
First Posted : February 23, 2012
Last Update Posted : January 24, 2018
Information provided by (Responsible Party):
TaiGen Biotechnology Co., Ltd.

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

Condition or disease Intervention/treatment Phase
Community-acquired Pneumonia Drug: Levofloxacin 500 mg placebol Drug: Nemonoxacin 3 tablets Phase 2

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  (Clinical Trial)
Actual Enrollment : 192 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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)
Study Start Date : August 2009
Actual Primary Completion Date : August 2010
Actual Study Completion Date : August 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia
U.S. FDA Resources

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
Levofloxacin 500 mg
Drug: Nemonoxacin 3 tablets
oral form,once daily,7~10 days

Primary Outcome Measures :
  1. Per subject clinical cure rate [ Time Frame: 16days ]
    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.

  2. Per subject microbiological cure rate [ Time Frame: 16days ]
    Microbiological cure rate equals to number of microbiological evaluable divided by number of eradicated or presumed eradicated.

Secondary Outcome Measures :
  1. Pharmacokinetic profile of nemonoxacin in CAP subjects [ Time Frame: 3days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01537250

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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: TaiGen Biotechnology Co., Ltd. Identifier: NCT01537250     History of Changes
Other Study ID Numbers: TG-873870-C-3
First Posted: February 23, 2012    Key Record Dates
Last Update Posted: January 24, 2018
Last Verified: January 2018

Keywords provided by TaiGen Biotechnology Co., Ltd.:

Additional relevant MeSH terms:
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Anti-Infective Agents, Urinary
Anti-Infective Agents
Renal Agents
Anti-Bacterial Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors