Phase II Clinical Study to Assess the Efficacy and Safety of Nemonoxacin Malate in Treating Adult Patients With Community-acquired Pneumonia (CAP)

Community-acquired Pneumonia Clinical Trial

Official title:

A Multi-center, Randomized, Double-blind, Double-dummy Parallel-controlled Phase II Clinical Study to Assess the Efficacy and Safety of Nemonoxacin Malate in Treating Adult Patients With Community-acquired Pneumonia (CAP)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01537250
• Other study ID #: TG-873870-C-3
• Status: Completed
• Phase: Phase 2
• First received: February 5, 2012
• Last updated: January 23, 2018
• Start date: August 2009
• Est. completion date: August 2010

Study information

• Verified date: January 2018
• 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 safety, tolerability and population pharmacokinetics of oral nemonoxacin in community-acquired pneumonia (CAP) subjects.

Description:

Evaluate clinical efficacy, microbiological efficacy and safety of Nemonoxacin adult patients with community-acquired pneumonia (CAP); and

A study on the population pharmacokinetics (PPK) of continuous oral administration of Nemonoxacin in adult patients with CAP.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 192
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. age of 18~70, BMI = 18 kg/m2

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:

1. Patients who have any of bronchiectasis and pulmonary disease.

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.

Related Conditions & MeSH terms

• Community-acquired Pneumonia
• Pneumonia

Intervention

Drug:
• 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

Locations

Country	Name	City	State
China	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	Shanghai Pudong New Area, Oriental Hospital	Shanghai
China	Shanghai Putuo District Central Hospital	Shanghai
China	Institute of Antibiotics,Huashan Hospital ,Fudan University	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

Sponsors (1)

Lead Sponsor	Collaborator
TaiGen Biotechnology Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Per subject clinical cure rate	Clinical cure rate equals to number of clinical evaluable divided by number of clinical cured. If subject's clnical outcome is evaluable by principal invastigator, he/she is defined as clinical evaluable.	16days
Primary	Per subject microbiological cure rate	Microbiological cure rate equals to number of microbiological evaluable divided by number of eradicated or presumed eradicated.	16days
Secondary	Pharmacokinetic profile of nemonoxacin in CAP subjects		3days