Clinical trial NCT01537250: Phase II Clinical Study to Assess the Efficacy and Safety of Nemonoxacin Malate in Treating Adult Patients With Community-acquired Pneumonia (CAP)
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Community-acquired Pneumonia
Keywords: CAP
Lead sponsor: TaiGen Biotechnology Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2012-02-23
Enrollment: 192
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Per subject clinical cure rate
timeFrame: 16days
measure: Per subject microbiological cure rate
timeFrame: 16days
Secondary outcomes:
measure: Pharmacokinetic profile of nemonoxacin in CAP subjects
timeFrame: 3days
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Chaoyang Hospital, Capital Medical University
city: Beijing
country: China
facility: Beijing Union Medical College Hospital, Chinese Academy of Medical Sciences
city: Beijing
country: China
facility: Peking University First Hospital
city: Beijing
country: China
facility: Peking University People's Hospital
city: Beijing
country: China
facility: PLA Second Artillery General Hospital
city: Beijing
country: China
facility: Zhen Hospital, Capital Medical University Beijing
city: Chongqing
country: China
facility: Daping Hospital, Third Military Medical University
city: Fujian
country: China
facility: First Affiliated Hospital of Fujian Medical University
city: Gansu
country: China
facility: Gansu Provincial People's Hospital
city: Guangzhou
country: China
facility: Guangzhou Red Cross Hospital
city: Guangzhou
country: China
facility: Second Affiliated Hospital of Sun Yat-sen
city: Guilin
country: China
facility: Affiliated Hospital of Guilin Medical College
city: Hubei
country: China
facility: Taihe Hospital in Shiyan City, Hubei Province
city: Hunan
country: China
facility: Third Xiangya Hospital, Central South University
city: Jiangxi
country: China
facility: Jiangxi Provincial People's Hospital
city: Jiangxi
country: China
facility: Second Affiliated Hospital of Nanchang University
city: Jinan
country: China
facility: Jinan Central Hospital
city: Liaoning
country: China
facility: Shengjing Hospital of China Medical University
city: Nanjing
country: China
facility: Nanjing General Hospital of Nanjing Military Region
city: Shanghai,
country: China
facility: Institute of Antibiotics,Huashan Hospital ,Fudan University
city: Shanghai
country: China
facility: Huashan Hospital ,Fudan University
city: Shanghai
country: China
facility: Institute of Antibiotics, Huashan Hospital, Fundan University
city: Shanghai
country: China
facility: Shanghai Pudong New Area, Oriental Hospital
city: Shanghai
country: China
facility: Shanghai Putuo District Central Hospital
city: Shanxi
country: China
facility: First Hospital of Shanxi Medical University
city: Shenyang
country: China
facility: People's Liberation Army General Hospital of Shenyang Military Region
city: ShenZhen
country: China
facility: Shenzhen People's Hospital
city: Sichuan
country: China
facility: West China Hospital of Sichuan University (Respiratory)
city: Wenzhou
country: China
facility: Second Affiliated Hospital of Wenzhou Medical College
city: Wuhan
country: China
facility: People's Hospital of Wuhan University
city: Wuhan
country: China
facility: Wuhan General Hospital of PLA Guangzhou Military Region
city: Zhejiang
country: China
facility: First Affiliated Hospital, Zhejiang University School of Medicine
Study officials:
affiliation: Huashan Hospital, Fundan University
name: Yingyuan Zhang, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Liu Y, Zhang Y, Wu J, Zhu D, Sun S, Zhao L, Wang X, Liu H, Ren Z, Wang C, Xiu Q, Xiao Z, Cao Z, Cui S, Yang H, Liang Y, Chen P, Lv Y, Hu C, Lv X, Liu S, Kuang J, Li J, Wang D, Chang L. A randomized, double-blind, multicenter Phase II study comparing the efficacy and safety of oral nemonoxacin with oral levofloxacin in the treatment of community-acquired pneumonia. J Microbiol Immunol Infect. 2017 Dec;50(6):811-820. doi: 10.1016/j.jmii.2015.09.005. Epub 2015 Dec 1.