A Phase III Study to Evaluate the Efficacy and Safety of Intravenous Infusion of Nemonoxacin in Treating CAP

Community-acquired Pneumonia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02205112
• Other study ID #: TG-873870-C-6
• Status: Completed
• Phase: Phase 3
• Start date: June 2014
• Est. completion date: May 15, 2017

Study information

• Verified date: October 2021
• Source: TaiGen Biotechnology Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 598
• Est. completion date: May 15, 2017
• Est. primary completion date: May 4, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Community-acquired Pneumonia
• Pneumonia

Intervention

Drug:
• Nemonoxacin

• Levofloxacin

Locations

Country	Name	City	State
China	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	Huadong Hospital Affiliated to Fudan University	Shanghai
China	Institute of Antibiotics, Huashan Hospital, Fundan 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
Taiwan	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
Taiwan	Kaohsiung Medical University Chung-Ho Memorial Hospital	Kaohsiung
Taiwan	Kaohsiung Veterans General Hospital	Kaohsiung
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
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

Sponsors (1)

Lead Sponsor	Collaborator
TaiGen Biotechnology Co., Ltd.

Countries where clinical trial is conducted

China,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Per subject clinical cure rate	The clinical cure rate will be evaluated according to signs and symptoms and changes in the chest X-ray	end of treatment and 7 to 14 days after the end of treatment
Secondary	Per subject microbiological cure rate	The microbiological cure rate will be evaluated according to the microbiological identification results of the central laboratory	end of treatment and 7 to 14 days after the end of treatment
Secondary	Per subject overall cure rate	Evaluate the overall efficacy after a comprehensive consideration of the clinical results and the bacteriological results.	end of treatment and 7 to 14 days after the end of treatment
Secondary	Safety evaluation	Incidence and severity of AE and changes in safety parameters from baseline	duration of trial