Clinical trial NCT02205112: A Phase III Study to Evaluate the Efficacy and Safety of Intravenous Infusion of Nemonoxacin in Treating CAP
Official title: A Multi-center, Randomized, Double-Blind, Parallel Comparative, Phase III Study to Evaluate the Efficacy and Safety of Intravenous Infusion of Nemonoxacin Versus Levofloxain in Treating Adult Patients With CAP
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Community-acquired Pneumonia
Keywords: intravenous nemonoxacin
community-acquired pneumonia
Lead sponsor: TaiGen Biotechnology Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2014-07-31
Enrollment: 598
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy, safety and pharmacokinetics of intravenous nemonoxacin compared with intravenous moxifloxacin in adult patients with community-acquired pneumonia (CAP).

Detailed description: Community-acquired Pneumonia (CAP) remains a leading cause of death in both developing and developed countries. In the choice of antibacterial agents used to treat CAP, fluoroquinolones have received considerable attention because of their wide spectrum of bactericidal activity. TG-873870 (Nemonoxacin), a non-fluorinated quinolone (NFQ), is a selective bacterial topoisomerase inhibitor.

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.

Eligibility criteria: Inclusion Criteria:

1. Ages between 18 and 80;
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:

1. Patients with PORT/PSI score I or VI.
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

Primary outcomes:
measure: Per subject clinical cure rate
timeFrame: end of treatment and 7 to 14 days after the end of treatment
Secondary outcomes:
measure: Per subject microbiological cure rate
timeFrame: end of treatment and 7 to 14 days after the end of treatment
measure: Per subject overall cure rate
timeFrame: end of treatment and 7 to 14 days after the end of treatment
measure: Safety evaluation
timeFrame: duration of trial
Other outcomes:
Locations:
city: Baotou
country: China
facility: Baotou Central Hospital
city: Beijing
country: China
facility: Aerospace Center Hospital
city: Beijing
country: China
facility: Affiliated Beijing Anzhen Hospital of Capital Medical University
city: Beijing
country: China
facility: Affiliated Beijing Chaoyang Hospital of Capital Medical University
city: Beijing
country: China
facility: Chinese People's Liberation Army General Hospital
city: Beijing
country: China
facility: Institute of Clinical Pharmacology, Peking University
city: Beijing
country: China
facility: Peking University People's Hospital
city: Changsha
country: China
facility: Changsha Central Hospital
city: Changsha
country: China
facility: The Third Changsha Hotpital
city: Changsha
country: China
facility: The Third Xiangya Hospital of Central South University
city: Chongqing
country: China
facility: Daping Hospital
city: Guangxi
country: China
facility: Guangxi Zhuang Autonomous Region People's Hospital
city: Guangzhou
country: China
facility: First Affiliated Hospital of Guangzhou Medical University
city: Guilin
country: China
facility: Guilin Medical School Affiliated Hospital
city: Haikou
country: China
facility: Hainan General Hospital
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital Zhejiang University School of Medicine
city: Hangzhou
country: China
facility: The Second Affiliated Hospital of Zhejiang University
city: Hefei
country: China
facility: The First Hospital of Anhui Medical University
city: Hohhot
country: China
facility: The Affilated Hospital of Inner Mongolia Medical University
city: Jilin
country: China
facility: The First Hospital of Jilin University
city: Jilin
country: China
facility: The Fourth Hospital of Jilin University
city: Jinan
country: China
facility: Jinan Central Hospital
city: Jinan
country: China
facility: The Second Hospital of Shandong University
city: Lanzhou
country: China
facility: Gansu Provincial People's Hospital
city: Nanchang
country: China
facility: Jiangxi Provincial People's Hospital
city: Nanchang
country: China
facility: Second Subsidiary Hospital of Nanchang Medical College
city: Nanjing
country: China
facility: General Hospital of Nanjing Military Command
city: Shanghai
country: China
facility: Institute of Antibiotics, Huashan Hospital, Fundan University
city: Shanghai
country: China
facility: Huadong Hospital Affiliated to Fudan University
city: Shanghai
country: China
facility: Shanghai East Hospital of Tongji University
city: Shanghai
country: China
facility: Shanghai Pulmonary Hospital
city: Shenyang
country: China
facility: General Hospital of Shenyang Military
city: Shenyang
country: China
facility: Shengjing Hospital
city: Shenzhen
country: China
facility: Shenzhen People's Hospital
city: Shenzhen
country: China
facility: The Second People's Hospital of Shenzhen
city: Sichuan
country: China
facility: General Hospital of Chengdu Military Region
city: Sichuan
country: China
facility: West China Center of Medical Sciences of Sichuan University
city: Taiyuan
country: China
facility: First Hospital of Shanxi Medical University
city: Wuxi
country: China
facility: Wuxi People's Hospital
city: Xi'an
country: China
facility: Tangdu Hospital
city: Xiamen
country: China
facility: The First Affilated Hospital of Xiamen University
city: Yangzhou
country: China
facility: Northern Jiangsu People's Hospital
city: Zhejiang
country: China
facility: The First Affiliated Hospital,College of Medicine,Zhejiang University
city: Chang Hua
country: Taiwan
facility: Changhua Christian Hospital
city: Chiayi City
country: Taiwan
facility: Chiayi Chang Gung Memorial Hospital
city: Hsinchu
country: Taiwan
facility: NTUH Hsin-Chu Branch
city: Hualien City
country: Taiwan
facility: Hualien Tzu Chi Hospital
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Chang Gung Memorial Hospital
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Veterans General Hospital
city: Keelung
country: Taiwan
facility: Keelung Chang Gung Memorial Hospital
city: New Taipei City
country: Taiwan
facility: Far Eastern Memorial Hospital
city: New Taipei City
country: Taiwan
facility: MacKay Memorial Hospital
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Taichung
country: Taiwan
facility: Chung Shan Medical University Hospital
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
city: Tainan
country: Taiwan
facility: Chi Mei Hospital, Liouying
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Taipei Medical University - Shuang Ho Hospital
city: Taipei
country: Taiwan
facility: Taipei Medical University Hospital
city: Taipei
country: Taiwan
facility: Taipei Municipal Wanfang Hospital
city: Taipei
country: Taiwan
facility: Tri-Service General Hospital
city: Yuli
country: Taiwan
facility: NTUH Yun-Lin Branch
Study officials:
References: