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

Phase 2

Completed

• Conditions: Community-acquired Pneumonia
• Interventions: Drug: Levofloxacin 500 mg placebol; Drug: Nemonoxacin 3 tablets

• Registration Number: NCT01537250
• Lead Sponsor: TaiGen Biotechnology Co., Ltd.

Brief Summary

The purpose of this study is to evaluate the safety, tolerability and population pharmacokinetics of oral nemonoxacin in community-acquired pneumonia (CAP) subjects.

Detailed 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.

Study Timeline

• Study Start: 2009-08
• Primary Completion: 2010-08
• Study Completion: 2010-08
• Study First Submitted: 2012-02-05
• Study First Submitted QC: 2012-02-16
• Study First Posted: 2012-02-23
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-23
• Last Update Posted: 2018-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 192

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nemonoxacin 750 mg	Levofloxacin 500 mg placebol	Nemonoxacin 750 mg 2 tablets.
Nemonoxacin 500 mg	Levofloxacin 500 mg placebol	Nemonoxacin 500 mg 3 tablets
Levofloxacin 500 mg	Nemonoxacin 3 tablets	Levofloxacin 500 mg

Primary Outcome Measures

Name	Time	Method
Per subject clinical cure rate	16days	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.
Per subject microbiological cure rate	16days	Microbiological cure rate equals to number of microbiological evaluable divided by number of eradicated or presumed eradicated.

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetic profile of nemonoxacin in CAP subjects	3days

Trial Locations

Locations (32)

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

Daping Hospital, Third Military Medical University; 🇨🇳 Chongqing, China

Zhen Hospital, Capital Medical University Beijing; 🇨🇳 Beijing, China

Second Affiliated Hospital of Sun Yat-sen; 🇨🇳 Guangzhou, China

Affiliated Hospital of Guilin Medical College; 🇨🇳 Guilin, China

Third Xiangya Hospital, Central South University; 🇨🇳 Hunan, China

Second Affiliated Hospital of Nanchang University; 🇨🇳 Jiangxi, China

Shanghai Putuo District Central Hospital; 🇨🇳 Shanghai, China

Nanjing General Hospital of Nanjing Military Region; 🇨🇳 Nanjing, China

Shenzhen People's Hospital; 🇨🇳 ShenZhen, China

Wuhan General Hospital of PLA Guangzhou Military Region; 🇨🇳 Wuhan, China

First Affiliated Hospital, Zhejiang University School of Medicine; 🇨🇳 Zhejiang, China

PLA Second Artillery General Hospital; 🇨🇳 Beijing, China

Gansu Provincial People's Hospital; 🇨🇳 Gansu, China

Guangzhou Red Cross Hospital; 🇨🇳 Guangzhou, China

Huashan Hospital ,Fudan University; 🇨🇳 Shanghai, China

Institute of Antibiotics, Huashan Hospital, Fundan University; 🇨🇳 Shanghai, China

Jiangxi Provincial People's Hospital; 🇨🇳 Jiangxi, China

Shengjing Hospital of China Medical University; 🇨🇳 Liaoning, China

People's Hospital of Wuhan University; 🇨🇳 Wuhan, China

Shanghai Pudong New Area, Oriental Hospital; 🇨🇳 Shanghai, China

People's Liberation Army General Hospital of Shenyang Military Region; 🇨🇳 Shenyang, China

West China Hospital of Sichuan University (Respiratory); 🇨🇳 Sichuan, China

Taihe Hospital in Shiyan City, Hubei Province; 🇨🇳 Hubei, China

First Affiliated Hospital of Fujian Medical University; 🇨🇳 Fujian, China

Institute of Antibiotics,Huashan Hospital ,Fudan University; 🇨🇳 Shanghai,, China

Jinan Central Hospital; 🇨🇳 Jinan, China

Second Affiliated Hospital of Wenzhou Medical College; 🇨🇳 Wenzhou, China

First Hospital of Shanxi Medical University; 🇨🇳 Shanxi, China