Phase II Clinical Study to Assess the Efficacy and Safety of Nemonoxacin Malate in Treating Adult Patients With Community-acquired Pneumonia (CAP)
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)
1 other identifier
interventional
192
1 country
32
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Aug 2009
Shorter than P25 for phase_2
32 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2010
CompletedFirst Submitted
Initial submission to the registry
February 5, 2012
CompletedFirst Posted
Study publicly available on registry
February 23, 2012
CompletedJanuary 24, 2018
January 1, 2018
1 year
February 5, 2012
January 23, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Per subject microbiological cure rate
Microbiological cure rate equals to number of microbiological evaluable divided by number of eradicated or presumed eradicated.
16days
Secondary Outcomes (1)
Pharmacokinetic profile of nemonoxacin in CAP subjects
3days
Study Arms (3)
Nemonoxacin 750 mg
ACTIVE COMPARATORNemonoxacin 750 mg 2 tablets.
Nemonoxacin 500 mg
ACTIVE COMPARATORNemonoxacin 500 mg 3 tablets
Levofloxacin 500 mg
ACTIVE COMPARATORLevofloxacin 500 mg
Interventions
Eligibility Criteria
You may qualify if:
- age of 18\~70, BMI ≥ 18 kg/m2
- Female patients must avoid pregnancy
- Patients who are clinically diagnosed with community-acquired pneumonia (CAP)
- Chest X-ray shows inflammatory exudation or infiltration image.
- Patients who used antibacterial agents (excluding quinolones) within 72 hours before
- The patient's disease condition permits oral administration
You may not qualify if:
- Patients who have any of bronchiectasis and pulmonary disease.
- Hospitalized within 14 days before enrollment
- Have a history of allergy to any quinolone or fluoroquinolone antibiotic
- Patients who suffered uncontrolled mental disorders, epilepsy or central nervous system diseases.
- Renal, liver insufficiency
- Malabsorption syndrome or other gastrointestinal diseases
- 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
- Steroids longterm use, the dose is at least 20mg of prednisone daily
- Patients under critical condition.
- Shows significant abnormality of the cardiac conduction system (CCS) or other abnormalities, or prolonged QTc
- Have a medical history of prolonged QTc, or require concomitant medication of drugs that will lead to prolongation of QTc
- Patients who received chemotherapy or anti-tumor therapy within 6 months
- Alcohol abused or drugs banned
- Patients who used quinolones within two weeks before enrollment
- Donated more than 500ml of blood within 3 months
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (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
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
Institute of Antibiotics,Huashan Hospital ,Fudan University
Shanghai, China
Shanghai Pudong New Area, Oriental Hospital
Shanghai, China
Shanghai Putuo District Central Hospital
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, China
Related Publications (1)
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.
PMID: 26748734DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yingyuan Zhang, PhD
Huashan Hospital, Fundan University
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 5, 2012
First Posted
February 23, 2012
Study Start
August 1, 2009
Primary Completion
August 1, 2010
Study Completion
August 1, 2010
Last Updated
January 24, 2018
Record last verified: 2018-01