Back to resultsStudy to Evaluate the Efficacy and Safety of Intravenous Infusion With Nemonoxacin Malate Sodium Chloride
Primary Purpose
Pneumonia
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Nemonoxacin 500 mg
Nemonoxacin 650 mg
Moxifloxacin 400 mg
Sponsored by
About this trial
This is an interventional treatment trial for Pneumonia focused on measuring Moxifloxacin
Eligibility Criteria
Inclusion Criteria:
- Ages between 18 and 75;
- 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)
- The patient is able to receive an intravenous infusion of the drug .
Exclusion Criteria:
- Patients with PORT/PSI score I or VI.
- Severe CAP is present if a patient needs invasive mechanical ventilation or requires vasopressors.
- Known or suspected severe bronchiectasis, cystic fibrosis, active pulmonary tuberculosis or infection with other mycobacteria or fungi, known bronchial obstruction, a history of post-obstructive pneumonia, other confounding respiratory diseases, such as lung cancer, malignancy metastatic to the lungs, lung abscess, empyema, suspected aspiration pneumonia due to vomiting, or non-bacterial respiratory infection (chronic obstructive pulmonary disease [COPD] is not exclusionary)
- Clinically significant conduction or other abnormality on 12-lead ECG, or QTc interval
- Potassium is < 3.5 mmol/L
- Any known disease that seriously affect the immune system
- Active hepatitis or decompensated cirrhosis;
- Have used quinolones or fluoroquinolones within 14 days before enrollment
- Patients who are being or will be on a long-term medication of steroids
Sites / Locations
- Institute of Antibiotics, Huashan Hospital, Fundan University
- Far eastern memorial hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
Nemonoxacin 500 mg
Nemonoxacin 650 mg
Moxifloxacin 400 mg
Arm Description
Nemonoxacin 500mg/250mL.
Nemonoxacin 650 mg/325mL
Moxifloxacin 400mg/250mL
Outcomes
Primary Outcome Measures
Difference in the Clinical Cure Rate of Two Doses of Intravenously Infused Nemonoxacin Malate Sodium Chloride Injection at Visit 4 in the mITT Population
The primary efficacy endpoint of this study was to evaluate whether the clinical cure rate of Nemonoxacin malate sodium chloride is non-inferior to that of Moxifloxacin at visit 4 in the mITT population. At visit 4, the Investigator would assess changes in the symptoms/signs/laboratory tests and chest X-rays/or CT scans associated with this infection, and determined the clinical efficacy in the subjects. The clinical efficacy of the study group and the control group was calculated according to the proportion and percentage of overall clinically cured and clinically ineffective patients in the treatment groups. If the lower limit of the 90% confidence interval for the difference in the clinical cure rate between the study drug and the control drug was larger than -15%, it would be established that the efficacy of Nemonoxacin malate sodium chloride injection was not inferior to that of Moxifloxacin Hydrochloride Sodium Chloride Injection in the treatment of moderate to severe adult CAP.
Secondary Outcome Measures
Difference in the Clinical Cure Rate of Two Doses of Intravenously Infused Nemonoxacin Malate Sodium Chloride Injection at Visit 4 in the Clinically Evaluable (CE) Population
The primary efficacy endpoint of this study was to evaluate whether the clinical cure rate of Nemonoxacin malate sodium chloride is non-inferior to that of Moxifloxacin at visit 4 in the CE population. At visit 4, the Investigator would assess changes in the symptoms/signs/laboratory tests and chest X-rays/or CT scans associated with this infection, and determined the clinical efficacy in the subjects. The clinical efficacy of the study group and the control group was calculated according to the proportion and percentage of overall clinically cured and clinically ineffective patients in the treatment groups. If the lower limit of the 90% confidence interval for the difference in the clinical cure rate between the study drug and the control drug was larger than -15%, it would be established that the efficacy of Nemonoxacin malate sodium chloride injection was not inferior to that of Moxifloxacin Hydrochloride Sodium Chloride Injection in the treatment of moderate to severe adult CAP.
Difference in the Clinical Cure Rate of Two Doses of Intravenously Infused Nemonoxacin Malate Sodium Chloride Injection at Visit 3 in the mITT Population
The primary efficacy endpoint of this study was to evaluate whether the clinical cure rate of Nemonoxacin malate sodium chloride is non-inferior to that of Moxifloxacin at visit 3 in the mITT population. At visit 3, the Investigator would assess changes in the symptoms/signs/laboratory tests and chest X-rays/or CT scans associated with this infection, and determined the clinical efficacy in the subjects. The clinical efficacy of the study group and the control group was calculated according to the proportion and percentage of overall clinically cured and clinically ineffective patients in the treatment groups. If the lower limit of the 90% confidence interval for the difference in the clinical cure rate between the study drug and the control drug was larger than -15%, it would be established that the efficacy of Nemonoxacin malate sodium chloride injection was not inferior to that of Moxifloxacin Hydrochloride Sodium Chloride Injection in the treatment of moderate to severe adult CAP.
Difference in the Clinical Cure Rate of Two Doses of Intravenously Infused Nemonoxacin Malate Sodium Chloride Injection at Visit 3 in the CE Population
The primary efficacy endpoint of this study was to evaluate whether the clinical cure rate of Nemonoxacin malate sodium chloride is non-inferior to that of Moxifloxacin at visit 3 in the CE population. At visit 3, the Investigator would assess changes in the symptoms/signs/laboratory tests and chest X-rays/or CT scans associated with this infection, and determined the clinical efficacy in the subjects. The clinical efficacy of the study group and the control group was calculated according to the proportion and percentage of overall clinically cured and clinically ineffective patients in the treatment groups. If the lower limit of the 90% confidence interval for the difference in the clinical cure rate between the study drug and the control drug was larger than -15%, it would be established that the efficacy of Nemonoxacin malate sodium chloride injection was not inferior to that of Moxifloxacin Hydrochloride Sodium Chloride Injection in the treatment of moderate to severe adult CAP.
Subject Number for Microbiologically Cured and Failure at Visit 4 in b-mITT (Bacteriological mITT) Population
Microbiological efficacy at visits 4 would be determined by assessing the identification results from the central laboratory. Subjects must satisfy at least one of the following in order to be evaluated for the microbiological efficacy:
Subjects whose respiratory culture from visit 1 was positive;
Subjects whose blood culture from visit 1 was positive.
The microbiological efficacy at Visit 4 and treatment group (determined by each subject) was determined by the number and percentage of microbiological success subjects. The difference in bacteriological success between Nemonoxacin malate sodium chloride injection and Moxifloxacin Hydrochloride Sodium Chloride Injection was tested using the logistic regression model.
Subject Number for Microbiologically Cured and Failure at Visit 4 in BE (Bacteriological Evaluable) Population
Microbiological efficacy at visits 4 would be determined by assessing the identification results from the central laboratory. Subjects must satisfy at least one of the following in order to be evaluated for the microbiological efficacy:
Subjects whose respiratory culture from visit 1 was positive;
Subjects whose blood culture from visit 1 was positive.
The microbiological efficacy at Visit 4 and treatment group (determined by each subject) was determined by the number and percentage of microbiological success subjects. The difference in bacteriological success between Nemonoxacin malate sodium chloride injection and Moxifloxacin Hydrochloride Sodium Chloride Injection was tested using the logistic regression model.
Subject Number for Microbiologically Cured and Failure at Visit 3 in b-mITT (Bacteriological mITT) Population
Microbiological efficacy at visits 3 would be determined by assessing the identification results from the central laboratory. Subjects must satisfy at least one of the following in order to be evaluated for the microbiological efficacy:
Subjects whose respiratory culture from visit 1 was positive;
Subjects whose blood culture from visit 1 was positive.
The microbiological efficacy at Visit 3 and treatment group (determined by each subject) was determined by the number and percentage of microbiological success subjects. The difference in bacteriological success between Nemonoxacin malate sodium chloride injection and Moxifloxacin Hydrochloride Sodium Chloride Injection was tested using the logistic regression model.
Subject Number for Microbiologically Cured and Failure at Visit 3 in BE (Bacteriological Evaluable) Population
Microbiological efficacy at visits 3 would be determined by assessing the identification results from the central laboratory. Subjects must satisfy at least one of the following in order to be evaluated for the microbiological efficacy:
Subjects whose respiratory culture from visit 1 was positive;
Subjects whose blood culture from visit 1 was positive.
The microbiological efficacy at Visit 3 and treatment group (determined by each subject) was determined by the number and percentage of microbiological success subjects. The difference in bacteriological success between Nemonoxacin malate sodium chloride injection and Moxifloxacin Hydrochloride Sodium Chloride Injection was tested using the logistic regression model.
Subject Number of Success and Failure in Overall Efficacy at Visit 4 in b-mITT (Bacteriological mITT) Population
Only subjects whose bacterial culture from visit 1 was positive would be evaluated for the overall efficacy. The overall efficacy (cured or ineffective) at Visit 4 and treatment group (determined by each subject) was determined by the number and percentage of subjects. The difference in bacteriological success between Nemonoxacin malate sodium chloride injection and Moxifloxacin Hydrochloride Sodium Chloride Injection was tested using the logistic regression model.
Subject Number of Success and Failure in Overall Efficacy at Visit 4 in BE (Bacteriological Evaluable) Population
Only subjects whose bacterial culture from visit 1 was positive would be evaluated for the overall efficacy. The overall efficacy (cured or ineffective) at Visit 4 and treatment group (determined by each subject) was determined by the number and percentage of subjects. The difference in bacteriological success between Nemonoxacin malate sodium chloride injection and Moxifloxacin Hydrochloride Sodium Chloride Injection was tested using the logistic regression model.
Subject Number of Success and Failure in Overall Efficacy at Visit 3 in b-mITT (Bacteriological mITT) Population
Only subjects whose bacterial culture from visit 1 was positive would be evaluated for the overall efficacy. The overall efficacy (cured or ineffective) at Visit 3 and treatment group (determined by each subject) was determined by the number and percentage of subjects. The difference in bacteriological success between Nemonoxacin malate sodium chloride injection and Moxifloxacin Hydrochloride Sodium Chloride Injection was tested using the logistic regression model.
Subject Number of Success and Failure in Overall Efficacy at Visit 3 in BE (Bacteriological Evaluable) Population
Only subjects whose bacterial culture from visit 1 was positive would be evaluated for the overall efficacy. The overall efficacy (cured or ineffective) at Visit 3 and treatment group (determined by each subject) was determined by the number and percentage of subjects. The difference in bacteriological success between Nemonoxacin malate sodium chloride injection and Moxifloxacin Hydrochloride Sodium Chloride Injection was tested using the logistic regression model.
Full Information
NCT ID
NCT01944774
First Posted
August 26, 2013
Last Updated
February 1, 2015
Sponsor
TaiGen Biotechnology Co., Ltd.
Collaborators
QPS-Qualitix, R&G Pharma Studies Co.,Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT01944774
Brief Title
Study to Evaluate the Efficacy and Safety of Intravenous Infusion With Nemonoxacin Malate Sodium Chloride
Official Title
A Multi-Center, Randomized, Double-Blind, Parallel Comparative, Phase II Study to Evaluate the Efficacy and Safety of Intravenous Infusion With Nemonoxacin Versus Moxifloxacin in Treating Adult Patients With Community-Acquired Pneumonia (CAP)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
TaiGen Biotechnology Co., Ltd.
Collaborators
QPS-Qualitix, R&G Pharma Studies Co.,Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
Detailed Description
Community-acquired Pneumonia (CAP) remains a leading cause of death in both developing and developed countries. In the choice of antibacterial agents used to treat CAP, fluoroquinolones have received considerable attention because of their wide spectrum of bactericidal activity. TG-873870 (Nemonoxacin), a non-fluorinated quinolone (NFQ), is a selective bacterial topoisomerase inhibitor.
This study will Evaluate the clinical efficacy, microbiological efficacy and safety of Intravenous Nemonoxacin compared with Intravenous Moxifloxacin in adult patients with community-acquired pneumonia.
Besides, the pharmacokinetics (PK) of Nemonoxacin in adult patients with CAP after continuous IV Infusion and the pharmacokinetic (PK)/pharmacodynamic (PD)are to be determined.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumonia
Keywords
Moxifloxacin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
207 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nemonoxacin 500 mg
Arm Type
Experimental
Arm Description
Nemonoxacin 500mg/250mL.
Arm Title
Nemonoxacin 650 mg
Arm Type
Experimental
Arm Description
Nemonoxacin 650 mg/325mL
Arm Title
Moxifloxacin 400 mg
Arm Type
Active Comparator
Arm Description
Moxifloxacin 400mg/250mL
Intervention Type
Drug
Intervention Name(s)
Nemonoxacin 500 mg
Intervention Description
IV Infusion, once daily for 7~14 days
Intervention Type
Drug
Intervention Name(s)
Nemonoxacin 650 mg
Intervention Description
IV Infusion, once daily for 7~14 days
Intervention Type
Drug
Intervention Name(s)
Moxifloxacin 400 mg
Intervention Description
IV Infusion, once daily for 7~14 days
Primary Outcome Measure Information:
Title
Difference in the Clinical Cure Rate of Two Doses of Intravenously Infused Nemonoxacin Malate Sodium Chloride Injection at Visit 4 in the mITT Population
Description
The primary efficacy endpoint of this study was to evaluate whether the clinical cure rate of Nemonoxacin malate sodium chloride is non-inferior to that of Moxifloxacin at visit 4 in the mITT population. At visit 4, the Investigator would assess changes in the symptoms/signs/laboratory tests and chest X-rays/or CT scans associated with this infection, and determined the clinical efficacy in the subjects. The clinical efficacy of the study group and the control group was calculated according to the proportion and percentage of overall clinically cured and clinically ineffective patients in the treatment groups. If the lower limit of the 90% confidence interval for the difference in the clinical cure rate between the study drug and the control drug was larger than -15%, it would be established that the efficacy of Nemonoxacin malate sodium chloride injection was not inferior to that of Moxifloxacin Hydrochloride Sodium Chloride Injection in the treatment of moderate to severe adult CAP.
Time Frame
Visit 1 (baseline, day -1~1) to Visit 4 (7-14 days after stopping the drug)
Secondary Outcome Measure Information:
Title
Difference in the Clinical Cure Rate of Two Doses of Intravenously Infused Nemonoxacin Malate Sodium Chloride Injection at Visit 4 in the Clinically Evaluable (CE) Population
Description
The primary efficacy endpoint of this study was to evaluate whether the clinical cure rate of Nemonoxacin malate sodium chloride is non-inferior to that of Moxifloxacin at visit 4 in the CE population. At visit 4, the Investigator would assess changes in the symptoms/signs/laboratory tests and chest X-rays/or CT scans associated with this infection, and determined the clinical efficacy in the subjects. The clinical efficacy of the study group and the control group was calculated according to the proportion and percentage of overall clinically cured and clinically ineffective patients in the treatment groups. If the lower limit of the 90% confidence interval for the difference in the clinical cure rate between the study drug and the control drug was larger than -15%, it would be established that the efficacy of Nemonoxacin malate sodium chloride injection was not inferior to that of Moxifloxacin Hydrochloride Sodium Chloride Injection in the treatment of moderate to severe adult CAP.
Time Frame
Visit 1 (baseline, day -1~1) to Visit 4 (7-14 days after stopping the drug)
Title
Difference in the Clinical Cure Rate of Two Doses of Intravenously Infused Nemonoxacin Malate Sodium Chloride Injection at Visit 3 in the mITT Population
Description
The primary efficacy endpoint of this study was to evaluate whether the clinical cure rate of Nemonoxacin malate sodium chloride is non-inferior to that of Moxifloxacin at visit 3 in the mITT population. At visit 3, the Investigator would assess changes in the symptoms/signs/laboratory tests and chest X-rays/or CT scans associated with this infection, and determined the clinical efficacy in the subjects. The clinical efficacy of the study group and the control group was calculated according to the proportion and percentage of overall clinically cured and clinically ineffective patients in the treatment groups. If the lower limit of the 90% confidence interval for the difference in the clinical cure rate between the study drug and the control drug was larger than -15%, it would be established that the efficacy of Nemonoxacin malate sodium chloride injection was not inferior to that of Moxifloxacin Hydrochloride Sodium Chloride Injection in the treatment of moderate to severe adult CAP.
Time Frame
Visit 1 (baseline, day -1~1) to Visit 3 (Within 24 hours after stopping the drug)
Title
Difference in the Clinical Cure Rate of Two Doses of Intravenously Infused Nemonoxacin Malate Sodium Chloride Injection at Visit 3 in the CE Population
Description
The primary efficacy endpoint of this study was to evaluate whether the clinical cure rate of Nemonoxacin malate sodium chloride is non-inferior to that of Moxifloxacin at visit 3 in the CE population. At visit 3, the Investigator would assess changes in the symptoms/signs/laboratory tests and chest X-rays/or CT scans associated with this infection, and determined the clinical efficacy in the subjects. The clinical efficacy of the study group and the control group was calculated according to the proportion and percentage of overall clinically cured and clinically ineffective patients in the treatment groups. If the lower limit of the 90% confidence interval for the difference in the clinical cure rate between the study drug and the control drug was larger than -15%, it would be established that the efficacy of Nemonoxacin malate sodium chloride injection was not inferior to that of Moxifloxacin Hydrochloride Sodium Chloride Injection in the treatment of moderate to severe adult CAP.
Time Frame
Visit 1 (baseline, day -1~1) to Visit 3 (Within 24 hours after stopping the drug)
Title
Subject Number for Microbiologically Cured and Failure at Visit 4 in b-mITT (Bacteriological mITT) Population
Description
Microbiological efficacy at visits 4 would be determined by assessing the identification results from the central laboratory. Subjects must satisfy at least one of the following in order to be evaluated for the microbiological efficacy:
Subjects whose respiratory culture from visit 1 was positive;
Subjects whose blood culture from visit 1 was positive.
The microbiological efficacy at Visit 4 and treatment group (determined by each subject) was determined by the number and percentage of microbiological success subjects. The difference in bacteriological success between Nemonoxacin malate sodium chloride injection and Moxifloxacin Hydrochloride Sodium Chloride Injection was tested using the logistic regression model.
Time Frame
Visit 1 (baseline, day -1~1) to Visit 4 (7-14 days after stopping the drug)
Title
Subject Number for Microbiologically Cured and Failure at Visit 4 in BE (Bacteriological Evaluable) Population
Description
Microbiological efficacy at visits 4 would be determined by assessing the identification results from the central laboratory. Subjects must satisfy at least one of the following in order to be evaluated for the microbiological efficacy:
Subjects whose respiratory culture from visit 1 was positive;
Subjects whose blood culture from visit 1 was positive.
The microbiological efficacy at Visit 4 and treatment group (determined by each subject) was determined by the number and percentage of microbiological success subjects. The difference in bacteriological success between Nemonoxacin malate sodium chloride injection and Moxifloxacin Hydrochloride Sodium Chloride Injection was tested using the logistic regression model.
Time Frame
Visit 1 (baseline, day -1~1) to Visit 4 (7-14 days after stopping the drug)
Title
Subject Number for Microbiologically Cured and Failure at Visit 3 in b-mITT (Bacteriological mITT) Population
Description
Microbiological efficacy at visits 3 would be determined by assessing the identification results from the central laboratory. Subjects must satisfy at least one of the following in order to be evaluated for the microbiological efficacy:
Subjects whose respiratory culture from visit 1 was positive;
Subjects whose blood culture from visit 1 was positive.
The microbiological efficacy at Visit 3 and treatment group (determined by each subject) was determined by the number and percentage of microbiological success subjects. The difference in bacteriological success between Nemonoxacin malate sodium chloride injection and Moxifloxacin Hydrochloride Sodium Chloride Injection was tested using the logistic regression model.
Time Frame
Visit 1 (baseline, day -1~1) to Visit 3 (Within 24 hours after stopping the drug)
Title
Subject Number for Microbiologically Cured and Failure at Visit 3 in BE (Bacteriological Evaluable) Population
Description
Microbiological efficacy at visits 3 would be determined by assessing the identification results from the central laboratory. Subjects must satisfy at least one of the following in order to be evaluated for the microbiological efficacy:
Subjects whose respiratory culture from visit 1 was positive;
Subjects whose blood culture from visit 1 was positive.
The microbiological efficacy at Visit 3 and treatment group (determined by each subject) was determined by the number and percentage of microbiological success subjects. The difference in bacteriological success between Nemonoxacin malate sodium chloride injection and Moxifloxacin Hydrochloride Sodium Chloride Injection was tested using the logistic regression model.
Time Frame
Visit 1 (baseline, day -1~1) to Visit 3 (Within 24 hours after stopping the drug)
Title
Subject Number of Success and Failure in Overall Efficacy at Visit 4 in b-mITT (Bacteriological mITT) Population
Description
Only subjects whose bacterial culture from visit 1 was positive would be evaluated for the overall efficacy. The overall efficacy (cured or ineffective) at Visit 4 and treatment group (determined by each subject) was determined by the number and percentage of subjects. The difference in bacteriological success between Nemonoxacin malate sodium chloride injection and Moxifloxacin Hydrochloride Sodium Chloride Injection was tested using the logistic regression model.
Time Frame
Visit 1 (baseline, day -1~1) to Visit 4 (7-14 days after stopping the drug)
Title
Subject Number of Success and Failure in Overall Efficacy at Visit 4 in BE (Bacteriological Evaluable) Population
Description
Only subjects whose bacterial culture from visit 1 was positive would be evaluated for the overall efficacy. The overall efficacy (cured or ineffective) at Visit 4 and treatment group (determined by each subject) was determined by the number and percentage of subjects. The difference in bacteriological success between Nemonoxacin malate sodium chloride injection and Moxifloxacin Hydrochloride Sodium Chloride Injection was tested using the logistic regression model.
Time Frame
Visit 1 (baseline, day -1~1) to Visit 4 (7-14 days after stopping the drug)
Title
Subject Number of Success and Failure in Overall Efficacy at Visit 3 in b-mITT (Bacteriological mITT) Population
Description
Only subjects whose bacterial culture from visit 1 was positive would be evaluated for the overall efficacy. The overall efficacy (cured or ineffective) at Visit 3 and treatment group (determined by each subject) was determined by the number and percentage of subjects. The difference in bacteriological success between Nemonoxacin malate sodium chloride injection and Moxifloxacin Hydrochloride Sodium Chloride Injection was tested using the logistic regression model.
Time Frame
Visit 1 (baseline, day -1~1) to Visit 3 (Within 24 hours after stopping the drug)
Title
Subject Number of Success and Failure in Overall Efficacy at Visit 3 in BE (Bacteriological Evaluable) Population
Description
Only subjects whose bacterial culture from visit 1 was positive would be evaluated for the overall efficacy. The overall efficacy (cured or ineffective) at Visit 3 and treatment group (determined by each subject) was determined by the number and percentage of subjects. The difference in bacteriological success between Nemonoxacin malate sodium chloride injection and Moxifloxacin Hydrochloride Sodium Chloride Injection was tested using the logistic regression model.
Time Frame
Visit 1 (baseline, day -1~1) to Visit 3 (Within 24 hours after stopping the drug)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Ages between 18 and 75;
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)
The patient is able to receive an intravenous infusion of the drug .
Exclusion Criteria:
Patients with PORT/PSI score I or VI.
Severe CAP is present if a patient needs invasive mechanical ventilation or requires vasopressors.
Known or suspected severe bronchiectasis, cystic fibrosis, active pulmonary tuberculosis or infection with other mycobacteria or fungi, known bronchial obstruction, a history of post-obstructive pneumonia, other confounding respiratory diseases, such as lung cancer, malignancy metastatic to the lungs, lung abscess, empyema, suspected aspiration pneumonia due to vomiting, or non-bacterial respiratory infection (chronic obstructive pulmonary disease [COPD] is not exclusionary)
Clinically significant conduction or other abnormality on 12-lead ECG, or QTc interval
Potassium is < 3.5 mmol/L
Any known disease that seriously affect the immune system
Active hepatitis or decompensated cirrhosis;
Have used quinolones or fluoroquinolones within 14 days before enrollment
Patients who are being or will be on a long-term medication of steroids
Facility Information:
Facility Name
Institute of Antibiotics, Huashan Hospital, Fundan University
City
Shanghai
ZIP/Postal Code
200040
Country
China
Facility Name
Far eastern memorial hospital
City
Taipei
Country
Taiwan
12. IPD Sharing Statement
Citations:
PubMed Identifier
25534726
Citation
Wu XJ, Zhang J, Guo BN, Zhang YY, Yu JC, Cao GY, Chen YC, Zhu DM, Ye XY, Wu JF, Shi YG, Chang LW, Chang YT, Tsai CY. Pharmacokinetics and pharmacodynamics of multiple-dose intravenous nemonoxacin in healthy Chinese volunteers. Antimicrob Agents Chemother. 2015 Mar;59(3):1446-54. doi: 10.1128/AAC.04039-14. Epub 2014 Dec 22.
Results Reference
derived
PubMed Identifier
25092690
Citation
Cao GY, Zhang J, Zhang YY, Guo BN, Yu JC, Wu XJ, Chen YC, Wu JF, Shi YG. Safety, tolerability, and pharmacokinetics of intravenous nemonoxacin in healthy chinese volunteers. Antimicrob Agents Chemother. 2014 Oct;58(10):6116-21. doi: 10.1128/AAC.02972-14. Epub 2014 Aug 4.
Results Reference
derived
Learn more about this trial
Study to Evaluate the Efficacy and Safety of Intravenous Infusion With Nemonoxacin Malate Sodium Chloride
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