A Phase III Study to Evaluate the Efficacy and Safety of Intravenous Infusion of Nemonoxacin in Treating CAP
NCT ID: NCT02205112
Last Updated: 2021-10-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
598 participants
INTERVENTIONAL
2014-06-30
2017-05-15
Brief Summary
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Detailed Description
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This study will evaluate the clinical efficacy, microbiological efficacy and safety of Intravenous nemonoxacin compared with Intravenous levofloxacin in adult patients with community-acquired pneumonia.
Besides, the populationpharmacokinetics (PPK) of nemonoxacin in adult patients with CAP after continuous IV Infusion and the pharmacokinetic (PK)/pharmacodynamic (PD)are to be determined.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Nemonoxacin 500 mg
Nemonoxacin 500mg/250mL, intravenous administration, once daily for 7\~14 days
Nemonoxacin
Levofloxacin 500mg
Levofloxacin: 500mg/100mL, intravenous administration, once daily for 7\~14 days
Levofloxacin
Interventions
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Nemonoxacin
Levofloxacin
Eligibility Criteria
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Inclusion Criteria
2. Weighs between 40 \~ 100 kg, and BMI ≥ 18 kg/m2;
3. Must have a clinical diagnosis of CAP
4. Chest X-ray and /or CT scan show new or persist/progressive infiltrates
5. Patients with PORT/PSI score II, III or IV.
6. If female, non-lactating and at no risk or pregnancy (post-menopausal or must use adequate birth control)
7. Male must use a reliable form of contraception.
8. Able to receive an intravenous infusion of the drug
9. Able to provide an adequate sputum and blood samples
10. Able to provide written informed consent
Exclusion Criteria
2. Severe CAP is present if a patient needs invasive mechanical ventilation or requires vasopressors.
3. Healthcare-associated pneumonia, hospital-acquired pneumonia, or hospitalized within 14 days before enrollment
4. Virus pneumonia, aspiration pneumonia, ventilator associated pneumonia, or intersstitial lung disease
5. Bronchial bostruction (exclusive of COPD), bronchiectasis, cystic fibrosis, known or suspected pneumocystis pneumonia, known or suspected tuberculosis, primary empyema thoracis, lung abscess, known or suspected lung cancer, or lung disease associated with autoimmune disorders.
6. Medical history of QT prolongation, require the treatment of arrhythmia using class IA or class III drugs, or NYHA functional class \>/= III
7. Clinically significant findings on 12-lead ECG, QTc interval\>450ms or potassium is \< 3.5 mmol/L or lower limit of normal at Screening
8. Immunocompromising illness, such as HIV infection
9. Fatal progressive disease or neurodegenerative diseases that prevent patients from effectively clearing pulmonary secretions
10. Have medical history of seizure, alcohol or drug abuse, suicide tendency, or psychosis that can effect the compliance
11. Have diseases that may affect intravenous infusion.
12. Active hepatitis or decompensated cirrhosis with ascites (Child-Pugh score 10-15/class C);
13. Renal Insufficiency or creatinine \>/= 1.1 ULN within 24 hr before first dose
14. ALT or AST \>/= 3x ULN, or BUN \>/= 30 mg/dL within 24 hr before first dose
15. Neutrophil \< 1000 mm3 within 24 hr before first dose
16. Received systemic antibiotics within 72 hr before first dose
17. Received probenecid within 24 hr before first dose or require the treatment with probenecid during study
18. Received quinolones or fluoroquinolones within 14 days before first dose
19. Received any investigational drugs within 30 days before first dose
20. Require the treatment with other systemic antibiotics during study
21. Patients who are being or will be on a long-term medication (over 2 weeks) of steroids (20mg/day)
22. Medical history of hypersensitivity to any quinolone, fluoroquinolone-associated tendinitis and tendon rupture, or myasthenia gravis
23. Current condition or abnormality that, in the opinion of the investigator, would compromise the safety of the subject or the quality of the data
24. Participated and received the study medication in previous clinical trials
18 Years
80 Years
ALL
No
Sponsors
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TaiGen Biotechnology Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Baotou Central Hospital
Baotou, , China
Aerospace Center Hospital
Beijing, , China
Affiliated Beijing Anzhen Hospital of Capital Medical University
Beijing, , China
Affiliated Beijing Chaoyang Hospital of Capital Medical University
Beijing, , China
Chinese People's Liberation Army General Hospital
Beijing, , China
Institute of Clinical Pharmacology, Peking University
Beijing, , China
Peking University People's Hospital
Beijing, , China
Changsha Central Hospital
Changsha, , China
The Third Changsha Hotpital
Changsha, , China
The Third Xiangya Hospital of Central South University
Changsha, , China
Daping Hospital
Chongqing, , China
Guangxi Zhuang Autonomous Region People's Hospital
Guangxi, , China
First Affiliated Hospital of Guangzhou Medical University
Guangzhou, , China
Guilin Medical School Affiliated Hospital
Guilin, , China
Hainan General Hospital
Haikou, , China
Sir Run Run Shaw Hospital Zhejiang University School of Medicine
Hangzhou, , China
The Second Affiliated Hospital of Zhejiang University
Hangzhou, , China
The First Hospital of Anhui Medical University
Hefei, , China
The Affilated Hospital of Inner Mongolia Medical University
Hohhot, , China
The First Hospital of Jilin University
Jilin, , China
The Fourth Hospital of Jilin University
Jilin, , China
Jinan Central Hospital
Jinan, , China
The Second Hospital of Shandong University
Jinan, , China
Gansu Provincial People's Hospital
Lanzhou, , China
Jiangxi Provincial People's Hospital
Nanchang, , China
Second Subsidiary Hospital of Nanchang Medical College
Nanchang, , China
General Hospital of Nanjing Military Command
Nanjing, , China
Institute of Antibiotics, Huashan Hospital, Fundan University
Shanghai, , China
Huadong Hospital Affiliated to Fudan University
Shanghai, , China
Shanghai East Hospital of Tongji University
Shanghai, , China
Shanghai Pulmonary Hospital
Shanghai, , China
General Hospital of Shenyang Military
Shenyang, , China
Shengjing Hospital
Shenyang, , China
Shenzhen People's Hospital
Shenzhen, , China
The Second People's Hospital of Shenzhen
Shenzhen, , China
General Hospital of Chengdu Military Region
Sichuan, , China
West China Center of Medical Sciences of Sichuan University
Sichuan, , China
First Hospital of Shanxi Medical University
Taiyuan, , China
Wuxi People's Hospital
Wuxi, , China
Tangdu Hospital
Xi'an, , China
The First Affilated Hospital of Xiamen University
Xiamen, , China
Northern Jiangsu People's Hospital
Yangzhou, , China
The First Affiliated Hospital,College of Medicine,Zhejiang University
Zhejiang, , China
Changhua Christian Hospital
Chang-hua, , Taiwan
Chiayi Chang Gung Memorial Hospital
Chiayi City, , Taiwan
NTUH Hsin-Chu Branch
Hsinchu, , Taiwan
Hualien Tzu Chi Hospital
Hualien City, , Taiwan
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, , Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, , Taiwan
Kaohsiung Veterans General Hospital
Kaohsiung City, , Taiwan
Keelung Chang Gung Memorial Hospital
Keelung, , Taiwan
Far Eastern Memorial Hospital
New Taipei City, , Taiwan
MacKay Memorial Hospital
New Taipei City, , Taiwan
China Medical University Hospital
Taichung, , Taiwan
Chung Shan Medical University Hospital
Taichung, , Taiwan
Taichung Veterans General Hospital
Taichung, , Taiwan
Chi Mei Hospital, Liouying
Tainan City, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Taipei Medical University - Shuang Ho Hospital
Taipei, , Taiwan
Taipei Medical University Hospital
Taipei, , Taiwan
Taipei Municipal Wanfang Hospital
Taipei, , Taiwan
Tri-Service General Hospital
Taipei, , Taiwan
NTUH Yun-Lin Branch
Yuli, , Taiwan
Countries
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Other Identifiers
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TG-873870-C-6
Identifier Type: -
Identifier Source: org_study_id