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| Name | Class |
|---|---|
| QPS-Qualitix | INDUSTRY |
| R&G Pharma Studies Co.,Ltd. | INDUSTRY |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nemonoxacin 500 mg | Experimental | Nemonoxacin 500mg/250mL. |
|
| Nemonoxacin 650 mg | Experimental | Nemonoxacin 650 mg/325mL |
|
| Moxifloxacin 400 mg | Active Comparator | Moxifloxacin 400mg/250mL |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nemonoxacin 500 mg | Drug | IV Infusion, once daily for 7~14 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Visit 1 (baseline, day -1~1) to Visit 4 (7-14 days after stopping the drug) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| LiWen Chang | Taigenbiotech | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Antibiotics, Huashan Hospital, Fundan University | Shanghai | 200040 | China | |||
| Far eastern memorial hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25534726 | Derived | 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. | |
| 25092690 |
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This study was conducted in 41 research centers in China and Taiwan. Among these, 11 research centers did not enroll participants. 207 subjects were randomly enrolled in the 30 research centers.
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| ID | Title | Description |
|---|---|---|
| FG000 | Nemonoxacin 500 mg | Nemonoxacin 500mg/250mL. Nemonoxacin 500 mg: IV Infusion, once daily for 7~14 days |
| FG001 | Nemonoxacin 650 mg | Nemonoxacin 650 mg/325mL Nemonoxacin 650 mg: IV Infusion, once daily for 7~14 days |
| FG002 | Moxifloxacin 400 mg | Moxifloxacin 400mg/250mL Moxifloxacin 400 mg: IV Infusion, once daily for 7~14 days |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
mITT population: Subjects who were screened and randomized, received at least one complete dose of the drug (Nemonoxacin or Moxifloxacin), met the minimal disease criteria (inclusion criteria 4, 5 and 7), and was evaluated at least once for clinical efficacy .
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| ID | Title | Description |
|---|---|---|
| BG000 | Nemonoxacin 500 mg | Nemonoxacin 500mg/250mL. Nemonoxacin 500 mg: IV Infusion, once daily for 7~14 days |
| BG001 | Nemonoxacin 650 mg | Nemonoxacin 650 mg/325mL Nemonoxacin 650 mg: IV Infusion, once daily for 7~14 days |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Subjects in the ITT population that met the minimal disease criteria, and was evaluated for clinical efficacy at least once were enrolled into the mITT population. | Posted | Number | participants | Visit 1 (baseline, day -1~1) to Visit 4 (7-14 days after stopping the drug) |
The whole study period: from Screening Vsit (day -1~1) to Visit 4 (7-14 days after stopping the drug)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Nemonoxacin 500 mg | Nemonoxacin 500mg/250mL. Nemonoxacin 500 mg: IV Infusion, once daily for 7~14 days |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bradycardia | Cardiac disorders | MedDRA 15.1 | Systematic Assessment | Possibly related to the study drug |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Alanine aminotransferase increased | Investigations | MedDRA 15.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chen-En Tsai, M.D., Ph.D. | TaiGen Biotechnology Co., Ltd. | +886-2-8177-7072 | 1211 | cetsai@taigenbiotech.com |
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| ID | Term |
|---|---|
| D011014 | Pneumonia |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C543520 | nemonoxacin |
| D000077266 | Moxifloxacin |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
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| Nemonoxacin 650 mg | Drug | IV Infusion, once daily for 7~14 days |
|
|
| Moxifloxacin 400 mg | Drug | IV Infusion, once daily for 7~14 days |
|
|
| Visit 1 (baseline, day -1~1) to Visit 4 (7-14 days after stopping the drug) |
| 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. | Visit 1 (baseline, day -1~1) to Visit 3 (Within 24 hours after stopping the drug) |
| 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. | Visit 1 (baseline, day -1~1) to Visit 3 (Within 24 hours after stopping the drug) |
| 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:
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. | Visit 1 (baseline, day -1~1) to Visit 4 (7-14 days after stopping the drug) |
| 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:
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. | Visit 1 (baseline, day -1~1) to Visit 4 (7-14 days after stopping the drug) |
| 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:
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. | Visit 1 (baseline, day -1~1) to Visit 3 (Within 24 hours after stopping the drug) |
| 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:
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. | Visit 1 (baseline, day -1~1) to Visit 3 (Within 24 hours after stopping the drug) |
| 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. | Visit 1 (baseline, day -1~1) to Visit 4 (7-14 days after stopping the drug) |
| 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. | Visit 1 (baseline, day -1~1) to Visit 4 (7-14 days after stopping the drug) |
| 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. | Visit 1 (baseline, day -1~1) to Visit 3 (Within 24 hours after stopping the drug) |
| 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. | Visit 1 (baseline, day -1~1) to Visit 3 (Within 24 hours after stopping the drug) |
| Taipei |
| Taiwan |
| 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. |
| Lack of Efficacy |
|
| Lost to Follow-up |
|
| BG002 | Moxifloxacin 400 mg | Moxifloxacin 400mg/250mL Moxifloxacin 400 mg: IV Infusion, once daily for 7~14 days |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Age, Customized | Number | participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Nationality | Number | participants |
|
| Height | Mean | Standard Deviation | cm |
|
| Weight | Mean | Standard Deviation | kg |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
| PORT/PSI score | The pneumonia severity index PSI or PORT Score is a clinical prediction rule that medical practitioners use to calculate the probability of morbidity and mortality among patients with CAP. Point values are given for various parameters of demographics, comorbidity, physical exam fndings, lab and radiographic findings. The total PSI score places a given patient into one of 5 risk classes. Classes I, II, and III are at low risk for death, and may be considered for outpatient treatment. Risk classes IV and V should be hospitalized and even an intensive care should be considered. | Number | participants |
|
| Smoking status | Number | participants |
|
| Drinking status | Number | participants |
|
|
|
|
|
| Secondary | 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. | Subjects in the mITT population that conformed to the protocol analysis plan with no major violation to the protocol were enrolled into the CE population. | Posted | Number | participants | Visit 1 (baseline, day -1~1) to Visit 4 (7-14 days after stopping the drug) |
|
|
|
|
| Secondary | 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. | Subjects in the ITT population that met the minimal disease criteria, and was evaluated for clinical efficacy at least once were enrolled into the mITT population. | Posted | Number | participants | Visit 1 (baseline, day -1~1) to Visit 3 (Within 24 hours after stopping the drug) |
|
|
|
|
| Secondary | 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. | Subjects in the mITT population that conformed to the protocol analysis plan with no major violation to the protocol were enrolled into the CE population. | Posted | Number | participants | Visit 1 (baseline, day -1~1) to Visit 3 (Within 24 hours after stopping the drug) |
|
|
|
|
| Secondary | 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:
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. | Subjects in the mITT population whose bacterial culture yielded at least one baseline bacterial isolate were enrolled into the b-mITT population. | Posted | Number | participants | Visit 1 (baseline, day -1~1) to Visit 4 (7-14 days after stopping the drug) |
|
|
|
|
| Secondary | 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:
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. | Subjects in the b-mITT population who conformed to the protocol analysis plan with no major violation to the protocol were enrolled into the BE population. | Posted | Number | participants | Visit 1 (baseline, day -1~1) to Visit 4 (7-14 days after stopping the drug) |
|
|
|
|
| Secondary | 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:
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. | Subjects in the mITT population whose bacterial culture yielded at least one baseline bacterial isolate were enrolled into the b-mITT population. | Posted | Number | participants | Visit 1 (baseline, day -1~1) to Visit 3 (Within 24 hours after stopping the drug) |
|
|
|
|
| Secondary | 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:
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. | Subjects in the b-mITT population who conformed to the protocol analysis plan with no major violation to the protocol were enrolled into the BE population. | Posted | Number | participants | Visit 1 (baseline, day -1~1) to Visit 3 (Within 24 hours after stopping the drug) |
|
|
|
|
| Secondary | 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. | Subjects in the mITT population whose bacterial culture yielded at least one baseline bacterial isolate were enrolled into the b-mITT population. | Posted | Number | participants | Visit 1 (baseline, day -1~1) to Visit 4 (7-14 days after stopping the drug) |
|
|
|
|
| Secondary | 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. | Subjects in the b-mITT population who conformed to the protocol analysis plan with no major violation to the protocol were enrolled into the BE population. | Posted | Number | participants | Visit 1 (baseline, day -1~1) to Visit 4 (7-14 days after stopping the drug) |
|
|
|
|
| Secondary | 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. | Subjects in the mITT population whose bacterial culture yielded at least one baseline bacterial isolate were enrolled into the b-mITT population. | Posted | Number | participants | Visit 1 (baseline, day -1~1) to Visit 3 (Within 24 hours after stopping the drug) |
|
|
|
|
| Secondary | 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. | Subjects in the b-mITT population who conformed to the protocol analysis plan with no major violation to the protocol were enrolled into the BE population. | Posted | Number | participants | Visit 1 (baseline, day -1~1) to Visit 3 (Within 24 hours after stopping the drug) |
|
|
|
|
| 3 |
| 68 |
| 51 |
| 68 |
| EG001 | Nemonoxacin 650 mg | Nemonoxacin 650 mg/325mL Nemonoxacin 650 mg: IV Infusion, once daily for 7~14 days | 1 | 67 | 41 | 67 |
| EG002 | Moxifloxacin 400 mg | Moxifloxacin 400mg/250mL Moxifloxacin 400 mg: IV Infusion, once daily for 7~14 days | 1 | 70 | 33 | 70 |
|
| Hypotension | Vascular disorders | MedDRA 15.1 | Systematic Assessment | Possibly related to the study drug |
|
| Worsening of congestive heart failure | Cardiac disorders | MedDRA 15.1 | Systematic Assessment | Possibly unrelated to the study drug |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment | Possibly unrelated to the study drug for SAE occurred in subjects in the Nemonoxacin 650mg study group and definitely unrelated to the study drug for for SAE occurred in subjects in the Nemonoxacin 500mg study group |
|
| Lung neoplasm malignant | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment | Definitely unrelated to the study drug |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| Red blood cells urine positive | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| Red blood cell count decreased | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| Electrocardiogram QT prolonged | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| Blood albumin decreased | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| Blood potassium decreased | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| Blood lactate dehydrogenase increased | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| Haematocrit decreased | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| Neutrophil percentage decreased | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| Haemoglobin decreased | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| White blood cell count increased | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| Blood creatine phosphokinase increased | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| Platelet count increased | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| Protein total decreased | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| C-reactive protein increased | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| Neutrophil count increased | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| Blood urea increased | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| Blood uric acid increased | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| Blood pressure increased | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| Alpha hydroxybutyrate dehydrogenase increased | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| Monocyte percentage increased | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| Monocyte count increased | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| Lymphocyte percentage increased | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| Lymphocyte count increased | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| Protein urine present | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| Red blood cells urine positive | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| Mean cell haemoglobin concentration decreased | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| Mean cell haemoglobin concentration increased | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| Prealbumin decreased | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| Eosinophil percentage increased | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| Eosinophil count increased | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| Neutrophil percentage increased | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| Electrocardiogram ST-T change | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| Electrocardiogram T wave amplitude decreased | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| Blood glucose decreased | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| Total bile acids increased | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| Infusion site erythema | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Infusion site pruritus | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Infusion site pain | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Infusion site discomfort | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Infusion site rash | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Infusion site swelling | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Flushing | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Infusion site erythema | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Frequent bowel movements | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Oesophagitis | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Hyperchlorhydria | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Mucous stools | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Haemorrhoidal haemorrhage | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Bradycardia | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
|
| Sinus bradycardia | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
|
| Supraventricular arrhythmias | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
|
| Cardiac conduction disorders | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
|
| Palpitation | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
|
| Chest discomfort | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Oral herpes | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Tinea manuum | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Tinea pedis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Gait disturbance | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Dysphemia | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Altered visual depth perception | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Nasal obstruction | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Chest pain | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Groin pain | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Spondyloarthropathy | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Hypoproteinaemia | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
|
| Hepatic steatosis | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
|
| Hypoacusis | Ear and labyrinth disorders | MedDRA 15.1 | Systematic Assessment |
|
| Cholelithiasis | Hepatobiliary disorders | MedDRA 15.1 | Systematic Assessment |
|
| Rheumatoid arthritis | Immune system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Urticaria | Immune system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Renal cyst | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
|
| Bladder mass | Renal and urinary disorders | MedDRA 15.1 | Systematic Assessment |
|
| Leukopenias NEC | Blood and lymphatic system disorders | MedDRA 15.1 | Systematic Assessment |
|
PI needs to inform sponsor and asks for permission before he/she discusses or publishes trial results after the trial is completed.
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| Title | Measurements |
|---|---|
|
| Regression, Logistic | 0.636 | Only P values less than 0.05 are considered statistically significant in this study. | Odds Ratio (OR) | 0.644 | 2-Sided | 95 | 0.104 | 3.999 | Non-Inferiority or Equivalence (legacy) | Clinical success rate was assumed for the experimental group (Nemonoxacin 650mg) and the control group (Moxifloxacin 400mg) were both 88%. The non-inferiority margin was defined as 15%, one-sided significance value was 0.05 (one-tailed α=0.05), power was 80%, and the assignment ratio was 1:1:1. |
| Title | Measurements |
|---|---|
|
| Not evaluable |
|
| Regression, Logistic | 0.445 | Only P values less than 0.05 are considered statistically significant in this study. | Odds Ratio (OR) | 0.508 | 2-Sided | 95 | 0.090 | 2.883 | Non-Inferiority or Equivalence (legacy) | Clinical success rate was assumed for the experimental group (Nemonoxacin 650mg) and the control group (Moxifloxacin 400mg) were both 88%. The non-inferiority margin was defined as 15%, one-sided significance value was 0.05 (one-tailed α=0.05), power was 80%, and the assignment ratio was 1:1:1. |
| Title | Measurements |
|---|---|
|
| Not evaluable |
|
| Regression, Logistic | 0.664 | Only P values less than 0.05 are considered statistically significant in this study. | Odds Ratio (OR) | 0.667 | 2-Sided | 95 | 0.107 | 4.144 | Non-Inferiority or Equivalence (legacy) | Clinical success rate was assumed for the experimental group (Nemonoxacin 650mg) and the control group (Moxifloxacin 400mg) were both 88%. The non-inferiority margin was defined as 15%, one-sided significance value was 0.05 (one-tailed α=0.05), power was 80%, and the assignment ratio was 1:1:1. |
| Title | Measurements |
|---|---|
|
| Not evaluable |
|
| Regression, Logistic |
| 0.961 |
Only P values less than 0.05 are considered statistically significant in this study. |
| Odds Ratio (OR) |
| 0.000 |
| 2-Sided |
The 2-sided 95% confidence interval of OR is (<0.001, >999.999). |
| Superiority or Other (legacy) |
| Title | Measurements |
|---|---|
|
| Not evaluable |
|
| Regression, Logistic |
| 0.962 |
Only P values less than 0.05 are considered statistically significant in this study. |
| Odds Ratio (OR) |
| 0.000 |
| 2-Sided |
The 2-sided 95% confidence interval of OR is (<0.001, >999.999). |
| Superiority or Other (legacy) |
| Title | Measurements |
|---|---|
|
| Not evaluable |
|
| Regression, Logistic |
| 0.962 |
Only P values less than 0.05 are considered statistically significant in this study. |
| Odds Ratio (OR) |
| 0.000 |
| 2-Sided |
The 2-sided 95% confidence interval of OR is (<0.001, >999.999). |
| Superiority or Other (legacy) |
| Title | Measurements |
|---|---|
|
| Not evaluable |
|
| Regression, Logistic |
| 0.962 |
Only P values less than 0.05 are considered statistically significant in this study. |
| Odds Ratio (OR) |
| 0.000 |
| 2-Sided |
The 2-sided 95% confidence interval of OR is (<0.001, >999.999). |
| Superiority or Other (legacy) |
| Title | Measurements |
|---|---|
|
| 0.619 |
Only P values less than 0.05 are considered statistically significant in this study. |
| Odds Ratio (OR) |
| 0.531 |
| 2-Sided |
| 95 |
| 0.044 |
| 6.444 |
| Superiority or Other (legacy) |
| Title | Measurements |
|---|---|
|
| 0.656 |
Only P values less than 0.05 are considered statistically significant in this study. |
| Odds Ratio (OR) |
| 0.567 |
| 2-Sided |
| 95 |
| 0.047 |
| 6.895 |
| Superiority or Other (legacy) |
| Title | Measurements |
|---|---|
|
| Unevaluable |
|
| 0.656 |
Only P values less than 0.05 are considered statistically significant in this study. |
| Odds Ratio (OR) |
| 0.567 |
| 2-Sided |
| 95 |
| 0.047 |
| 6.895 |
| Superiority or Other (legacy) |
| Title | Measurements |
|---|---|
|
| 0.656 |
Only P values less than 0.05 are considered statistically significant in this study. |
| Odds Ratio (OR) |
| 0.567 |
| 2-Sided |
| 95 |
| 0.047 |
| 6.895 |
| Superiority or Other (legacy) |