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

Sponsor

TaiGen Biotechnology Co., Ltd. (Industry)

Overall Status

Completed

CT.gov ID

NCT02205112

Collaborator

(none)

598

Enrollment

Locations

Arms

35.4

Duration (Months)

9.5

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Community-acquired Pneumonia	Drug: Nemonoxacin Drug: Levofloxacin	Phase 3

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

598 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

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 Start Date :

Jun 1, 2014

Actual Primary Completion Date :

May 4, 2017

Actual Study Completion Date :

May 15, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Nemonoxacin 500 mg Nemonoxacin 500mg/250mL, intravenous administration, once daily for 7~14 days	Drug: Nemonoxacin
Active Comparator: Levofloxacin 500mg Levofloxacin: 500mg/100mL, intravenous administration, once daily for 7~14 days	Drug: Levofloxacin

Arm

Intervention/Treatment

Experimental: Nemonoxacin 500 mg

Nemonoxacin 500mg/250mL, intravenous administration, once daily for 7~14 days

Drug: Nemonoxacin

Active Comparator: Levofloxacin 500mg

Levofloxacin: 500mg/100mL, intravenous administration, once daily for 7~14 days

Drug: Levofloxacin

Outcome Measures

Primary Outcome Measures

Per subject clinical cure rate [end of treatment and 7 to 14 days after the end of treatment]
The clinical cure rate will be evaluated according to signs and symptoms and changes in the chest X-ray

Secondary Outcome Measures

Per subject microbiological cure rate [end of treatment and 7 to 14 days after the end of treatment]
The microbiological cure rate will be evaluated according to the microbiological identification results of the central laboratory
Per subject overall cure rate [end of treatment and 7 to 14 days after the end of treatment]
Evaluate the overall efficacy after a comprehensive consideration of the clinical results and the bacteriological results.
Safety evaluation [duration of trial]
Incidence and severity of AE and changes in safety parameters from baseline

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Ages between 18 and 80;
Weighs between 40 ~ 100 kg, and BMI ≥ 18 kg/m2;
Must have a clinical diagnosis of CAP
Chest X-ray and /or CT scan show new or persist/progressive infiltrates
Patients with PORT/PSI score II, III or IV.
If female, non-lactating and at no risk or pregnancy (post-menopausal or must use adequate birth control)
Male must use a reliable form of contraception.
Able to receive an intravenous infusion of the drug
Able to provide an adequate sputum and blood samples
Able to provide written informed consent

Exclusion Criteria:

Patients with PORT/PSI score I or VI.
Severe CAP is present if a patient needs invasive mechanical ventilation or requires vasopressors.
Healthcare-associated pneumonia, hospital-acquired pneumonia, or hospitalized within 14 days before enrollment
Virus pneumonia, aspiration pneumonia, ventilator associated pneumonia, or intersstitial lung disease
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.
Medical history of QT prolongation, require the treatment of arrhythmia using class IA or class III drugs, or NYHA functional class >/= III
Clinically significant findings on 12-lead ECG, QTc interval>450ms or potassium is < 3.5 mmol/L or lower limit of normal at Screening
Immunocompromising illness, such as HIV infection
Fatal progressive disease or neurodegenerative diseases that prevent patients from effectively clearing pulmonary secretions
Have medical history of seizure, alcohol or drug abuse, suicide tendency, or psychosis that can effect the compliance
Have diseases that may affect intravenous infusion.
Active hepatitis or decompensated cirrhosis with ascites (Child-Pugh score 10-15/class C);
Renal Insufficiency or creatinine >/= 1.1 ULN within 24 hr before first dose
ALT or AST >/= 3x ULN, or BUN >/= 30 mg/dL within 24 hr before first dose
Neutrophil < 1000 mm3 within 24 hr before first dose
Received systemic antibiotics within 72 hr before first dose
Received probenecid within 24 hr before first dose or require the treatment with probenecid during study
Received quinolones or fluoroquinolones within 14 days before first dose
Received any investigational drugs within 30 days before first dose
Require the treatment with other systemic antibiotics during study
Patients who are being or will be on a long-term medication (over 2 weeks) of steroids (20mg/day)
Medical history of hypersensitivity to any quinolone, fluoroquinolone-associated tendinitis and tendon rupture, or myasthenia gravis
Current condition or abnormality that, in the opinion of the investigator, would compromise the safety of the subject or the quality of the data
Participated and received the study medication in previous clinical trials

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Baotou Central Hospital	Baotou	China
2	Aerospace Center Hospital	Beijing	China
3	Affiliated Beijing Anzhen Hospital of Capital Medical University	Beijing	China
4	Affiliated Beijing Chaoyang Hospital of Capital Medical University	Beijing	China
5	Chinese People's Liberation Army General Hospital	Beijing	China
6	Institute of Clinical Pharmacology, Peking University	Beijing	China
7	Peking University People's Hospital	Beijing	China
8	Changsha Central Hospital	Changsha	China
9	The Third Changsha Hotpital	Changsha	China
10	The Third Xiangya Hospital of Central South University	Changsha	China
11	Daping Hospital	Chongqing	China
12	Guangxi Zhuang Autonomous Region People's Hospital	Guangxi	China
13	First Affiliated Hospital of Guangzhou Medical University	Guangzhou	China
14	Guilin Medical School Affiliated Hospital	Guilin	China
15	Hainan General Hospital	Haikou	China
16	Sir Run Run Shaw Hospital Zhejiang University School of Medicine	Hangzhou	China
17	The Second Affiliated Hospital of Zhejiang University	Hangzhou	China
18	The First Hospital of Anhui Medical University	Hefei	China
19	The Affilated Hospital of Inner Mongolia Medical University	Hohhot	China
20	The First Hospital of Jilin University	Jilin	China
21	The Fourth Hospital of Jilin University	Jilin	China
22	Jinan Central Hospital	Jinan	China
23	The Second Hospital of Shandong University	Jinan	China
24	Gansu Provincial People's Hospital	Lanzhou	China
25	Jiangxi Provincial People's Hospital	Nanchang	China
26	Second Subsidiary Hospital of Nanchang Medical College	Nanchang	China
27	General Hospital of Nanjing Military Command	Nanjing	China
28	Institute of Antibiotics, Huashan Hospital, Fundan University	Shanghai	China	200040
29	Huadong Hospital Affiliated to Fudan University	Shanghai	China
30	Shanghai East Hospital of Tongji University	Shanghai	China
31	Shanghai Pulmonary Hospital	Shanghai	China
32	General Hospital of Shenyang Military	Shenyang	China
33	Shengjing Hospital	Shenyang	China
34	Shenzhen People's Hospital	Shenzhen	China
35	The Second People's Hospital of Shenzhen	Shenzhen	China
36	General Hospital of Chengdu Military Region	Sichuan	China
37	West China Center of Medical Sciences of Sichuan University	Sichuan	China
38	First Hospital of Shanxi Medical University	Taiyuan	China
39	Wuxi People's Hospital	Wuxi	China
40	Tangdu Hospital	Xi'an	China
41	The First Affilated Hospital of Xiamen University	Xiamen	China
42	Northern Jiangsu People's Hospital	Yangzhou	China
43	The First Affiliated Hospital,College of Medicine,Zhejiang University	Zhejiang	China
44	Changhua Christian Hospital	Chang Hua	Taiwan
45	Chiayi Chang Gung Memorial Hospital	Chiayi City	Taiwan
46	NTUH Hsin-Chu Branch	Hsinchu	Taiwan
47	Hualien Tzu Chi Hospital	Hualien City	Taiwan
48	Kaohsiung Chang Gung Memorial Hospital	Kaohsiung	Taiwan
49	Kaohsiung Medical University Chung-Ho Memorial Hospital	Kaohsiung	Taiwan
50	Kaohsiung Veterans General Hospital	Kaohsiung	Taiwan
51	Keelung Chang Gung Memorial Hospital	Keelung	Taiwan
52	Far Eastern Memorial Hospital	New Taipei City	Taiwan
53	MacKay Memorial Hospital	New Taipei City	Taiwan
54	China Medical University Hospital	Taichung	Taiwan
55	Chung Shan Medical University Hospital	Taichung	Taiwan
56	Taichung Veterans General Hospital	Taichung	Taiwan
57	Chi Mei Hospital, Liouying	Tainan	Taiwan
58	National Taiwan University Hospital	Taipei	Taiwan
59	Taipei Medical University - Shuang Ho Hospital	Taipei	Taiwan
60	Taipei Medical University Hospital	Taipei	Taiwan
61	Taipei Municipal Wanfang Hospital	Taipei	Taiwan
62	Tri-Service General Hospital	Taipei	Taiwan
63	NTUH Yun-Lin Branch	Yuli	Taiwan