A Phase III Study to Evaluate the Efficacy and Safety of Intravenous Infusion of Nemonoxacin in Treating CAP
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
1 other identifier
interventional
598
2 countries
63
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jun 2014
Typical duration for phase_3
63 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2014
CompletedFirst Submitted
Initial submission to the registry
July 27, 2014
CompletedFirst Posted
Study publicly available on registry
July 31, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 4, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
May 15, 2017
CompletedOctober 25, 2021
October 1, 2021
2.9 years
July 27, 2014
October 22, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Per subject clinical cure rate
The clinical cure rate will be evaluated according to signs and symptoms and changes in the chest X-ray
end of treatment and 7 to 14 days after the end of treatment
Secondary Outcomes (3)
Per subject microbiological cure rate
end of treatment and 7 to 14 days after the end of treatment
Per subject overall cure rate
end of treatment and 7 to 14 days after the end of treatment
Safety evaluation
duration of trial
Study Arms (2)
Nemonoxacin 500 mg
EXPERIMENTALNemonoxacin 500mg/250mL, intravenous administration, once daily for 7\~14 days
Levofloxacin 500mg
ACTIVE COMPARATORLevofloxacin: 500mg/100mL, intravenous administration, once daily for 7\~14 days
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +9 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (63)
Baotou Central Hospital
Baotou, China
Aerospace Center Hospital
Beijing, China
Affiliated Beijing Anzhen Hospital of Capital Medical University
Beijing, China
Affiliated Beijing Chaoyang Hospital of Capital Medical University
Beijing, China
Chinese People's Liberation Army General Hospital
Beijing, China
Institute of Clinical Pharmacology, Peking University
Beijing, China
Peking University People's Hospital
Beijing, China
Changsha Central Hospital
Changsha, China
The Third Changsha Hotpital
Changsha, China
The Third Xiangya Hospital of Central South University
Changsha, China
Daping Hospital
Chongqing, China
Guangxi Zhuang Autonomous Region People's Hospital
Guangxi, China
First Affiliated Hospital of Guangzhou Medical University
Guangzhou, China
Guilin Medical School Affiliated Hospital
Guilin, China
Hainan General Hospital
Haikou, China
Sir Run Run Shaw Hospital Zhejiang University School of Medicine
Hangzhou, China
The Second Affiliated Hospital of Zhejiang University
Hangzhou, China
The First Hospital of Anhui Medical University
Hefei, China
The Affilated Hospital of Inner Mongolia Medical University
Hohhot, China
The First Hospital of Jilin University
Jilin, China
The Fourth Hospital of Jilin University
Jilin, China
Jinan Central Hospital
Jinan, China
The Second Hospital of Shandong University
Jinan, China
Gansu Provincial People's Hospital
Lanzhou, China
Jiangxi Provincial People's Hospital
Nanchang, China
Second Subsidiary Hospital of Nanchang Medical College
Nanchang, China
General Hospital of Nanjing Military Command
Nanjing, China
Institute of Antibiotics, Huashan Hospital, Fundan University
Shanghai, 200040, China
Huadong Hospital Affiliated to Fudan University
Shanghai, China
Shanghai East Hospital of Tongji University
Shanghai, China
Shanghai Pulmonary Hospital
Shanghai, China
General Hospital of Shenyang Military
Shenyang, China
Shengjing Hospital
Shenyang, China
Shenzhen People's Hospital
Shenzhen, China
The Second People's Hospital of Shenzhen
Shenzhen, China
General Hospital of Chengdu Military Region
Sichuan, China
West China Center of Medical Sciences of Sichuan University
Sichuan, China
First Hospital of Shanxi Medical University
Taiyuan, China
Wuxi People's Hospital
Wuxi, China
Tangdu Hospital
Xi'an, China
The First Affilated Hospital of Xiamen University
Xiamen, China
Northern Jiangsu People's Hospital
Yangzhou, China
The First Affiliated Hospital,College of Medicine,Zhejiang University
Zhejiang, China
Changhua Christian Hospital
Chang-hua, Taiwan
Chiayi Chang Gung Memorial Hospital
Chiayi City, Taiwan
NTUH Hsin-Chu Branch
Hsinchu, Taiwan
Hualien Tzu Chi Hospital
Hualien City, Taiwan
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Taiwan
Kaohsiung Veterans General Hospital
Kaohsiung City, Taiwan
Keelung Chang Gung Memorial Hospital
Keelung, Taiwan
Far Eastern Memorial Hospital
New Taipei City, Taiwan
MacKay Memorial Hospital
New Taipei City, Taiwan
China Medical University Hospital
Taichung, Taiwan
Chung Shan Medical University Hospital
Taichung, Taiwan
Taichung Veterans General Hospital
Taichung, Taiwan
Chi Mei Hospital, Liouying
Tainan, Taiwan
National Taiwan University Hospital
Taipei, Taiwan
Taipei Medical University - Shuang Ho Hospital
Taipei, Taiwan
Taipei Medical University Hospital
Taipei, Taiwan
Taipei Municipal Wanfang Hospital
Taipei, Taiwan
Tri-Service General Hospital
Taipei, Taiwan
NTUH Yun-Lin Branch
Yuli, Taiwan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 27, 2014
First Posted
July 31, 2014
Study Start
June 1, 2014
Primary Completion
May 4, 2017
Study Completion
May 15, 2017
Last Updated
October 25, 2021
Record last verified: 2021-10