Phase II Clinical Study to Assess the Efficacy and Safety of Nemonoxacin Malate in Treating Adult Patients With Community-acquired Pneumonia (CAP)
NCT ID: NCT01537250
Last Updated: 2018-01-24
Study Results
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Basic Information
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COMPLETED
PHASE2
192 participants
INTERVENTIONAL
2009-08-31
2010-08-31
Brief Summary
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Detailed Description
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A study on the population pharmacokinetics (PPK) of continuous oral administration of Nemonoxacin in adult patients with CAP.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Nemonoxacin 750 mg
Nemonoxacin 750 mg 2 tablets.
Levofloxacin 500 mg placebol
oral form,,once adily,7\~10 days
Nemonoxacin 500 mg
Nemonoxacin 500 mg 3 tablets
Levofloxacin 500 mg placebol
oral form,,once adily,7\~10 days
Levofloxacin 500 mg
Levofloxacin 500 mg
Nemonoxacin 3 tablets
oral form,once daily,7\~10 days
Interventions
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Levofloxacin 500 mg placebol
oral form,,once adily,7\~10 days
Levofloxacin 500 mg placebol
oral form,,once adily,7\~10 days
Nemonoxacin 3 tablets
oral form,once daily,7\~10 days
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
70 Years
ALL
No
Sponsors
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TaiGen Biotechnology Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Yingyuan Zhang, PhD
Role: PRINCIPAL_INVESTIGATOR
Huashan Hospital, Fundan University
Locations
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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
Huashan Hospital ,Fudan University
Shanghai, , China
Institute of Antibiotics, Huashan Hospital, Fundan University
Shanghai, , China
Institute of Antibiotics,Huashan Hospital ,Fudan 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
Countries
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References
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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.
Other Identifiers
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TG-873870-C-3
Identifier Type: -
Identifier Source: org_study_id
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