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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
TaiGen Biotechnology Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01537250
First received: February 5, 2012
Last updated: February 16, 2012
Last verified: February 2012
  Purpose

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


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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)

Resource links provided by NLM:


Further study details as provided by TaiGen Biotechnology Co., Ltd.:

Primary Outcome Measures:
  • Per subject clinical cure rate [ Time Frame: 16days ] [ Designated as safety issue: Yes ]
  • Per subject microbiological cure rate [ Time Frame: 16days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pharmacokinetic profile of nemonoxacin in CAP subjects [ Time Frame: 3days ] [ Designated as safety issue: No ]

Enrollment: 192
Study Start Date: August 2009
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01537250

Locations
China
Peking University People's Hospital
Beijing, China
Peking University First Hospital
Beijing, China
Zhen Hospital, Capital Medical University Beijing
Beijing, China
PLA Second Artillery General Hospital
Beijing, China
Beijing Chaoyang Hospital, Capital Medical University
Beijing, China
Beijing Union Medical College Hospital, Chinese Academy of Medical Sciences
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
Second Affiliated Hospital of Sun Yat-sen
Guangzhou, China
Guangzhou Red Cross Hospital
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
Second Affiliated Hospital of Nanchang University
Jiangxi, China
Jiangxi Provincial People's Hospital
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, Fundan University
Shanghai, China
Shanghai Pudong New Area, Oriental Hospital
Shanghai, China
Shanghai Putuo District Central Hospital
Shanghai, China
Huashan Hospital ,Fudan University
Shanghai, China
Institute of Antibiotics,Huashan Hospital ,Fudan University
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
Wuhan General Hospital of PLA Guangzhou Military Region
Wuhan, China
People's Hospital of Wuhan University
Wuhan, China
First Affiliated Hospital, Zhejiang University School of Medicine
Zhejiang, China
Sponsors and Collaborators
TaiGen Biotechnology Co., Ltd.
Investigators
Principal Investigator: Yingyuan Zhang, PhD Huashan Hospital, Fundan University
  More Information

No publications provided

Responsible Party: TaiGen Biotechnology Co., Ltd.
ClinicalTrials.gov Identifier: NCT01537250     History of Changes
Other Study ID Numbers: TG-873870-C-3
Study First Received: February 5, 2012
Last Updated: February 16, 2012
Health Authority: China: Food and Drug Administration

Keywords provided by TaiGen Biotechnology Co., Ltd.:
CAP

Additional relevant MeSH terms:
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Levofloxacin
Ofloxacin
Anti-Infective Agents, Urinary
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Renal Agents
Anti-Bacterial Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

ClinicalTrials.gov processed this record on August 21, 2014