Pneumonia
Conditions
Keywords
Moxifloxacin
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.
Interventions
DRUGNemonoxacin 500 mg
IV Infusion, once daily for 7\ 14 days
DRUGNemonoxacin 650 mg
IV Infusion, once daily for 7\ 14 days
DRUGMoxifloxacin 400 mg
IV Infusion, once daily for 7\ 14 days
Sponsors
QPS-Qualitix
R&G Pharma Studies Co.,Ltd.
TaiGen Biotechnology Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Ages between 18 and 75; 2. Weighs between 40 \ 100 kg, and BMI ≥ 18 kg/m2; 3. Must have a clinical diagnosis of CAP 4. Chest X-ray and /or CT scan show new or persist/progressive infiltrates 5. Patients with PORT/PSI score II, III or IV. 6. If female, non-lactating and at no risk or pregnancy (post-menopausal or must use adequate birth control) 7. The patient is able to receive an intravenous infusion of the drug .
Exclusion criteria
1. Patients with PORT/PSI score I or VI. 2. Severe CAP is present if a patient needs invasive mechanical ventilation or requires vasopressors. 3. 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) 4. Clinically significant conduction or other abnormality on 12-lead ECG, or QTc interval 5. Potassium is \< 3.5 mmol/L 6. Any known disease that seriously affect the immune system 7. Active hepatitis or decompensated cirrhosis; 8. Have used quinolones or fluoroquinolones within 14 days before enrollment 9. Patients who are being or will be on a long-term medication of steroids
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in the Clinical Cure Rate of Two Doses of Intravenously Infused Nemonoxacin Malate Sodium Chloride Injection at Visit 4 in the mITT Population | Visit 1 (baseline, day -1~1) to Visit 4 (7-14 days after stopping the drug) | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | Visit 1 (baseline, day -1~1) to Visit 4 (7-14 days after stopping the drug) | 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 | Visit 1 (baseline, day -1~1) to Visit 3 (Within 24 hours after stopping the drug) | 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 | Visit 1 (baseline, day -1~1) to Visit 3 (Within 24 hours after stopping the drug) | 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 | Visit 1 (baseline, day -1~1) to Visit 4 (7-14 days after stopping the drug) | 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: 1. Subjects whose respiratory culture from visit 1 was positive; 2. 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 | Visit 1 (baseline, day -1~1) to Visit 3 (Within 24 hours after stopping the drug) | 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: 1. Subjects whose respiratory culture from visit 1 was positive; 2. 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 4 in BE (Bacteriological Evaluable) Population | Visit 1 (baseline, day -1~1) to Visit 4 (7-14 days after stopping the drug) | 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: 1. Subjects whose respiratory culture from visit 1 was positive; 2. 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 of Success and Failure in Overall Efficacy at Visit 4 in b-mITT (Bacteriological mITT) Population | Visit 1 (baseline, day -1~1) to Visit 4 (7-14 days after stopping the drug) | 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 | Visit 1 (baseline, day -1~1) to Visit 4 (7-14 days after stopping the drug) | 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 | Visit 1 (baseline, day -1~1) to Visit 3 (Within 24 hours after stopping the drug) | 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 | Visit 1 (baseline, day -1~1) to Visit 3 (Within 24 hours after stopping the drug) | 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 for Microbiologically Cured and Failure at Visit 3 in BE (Bacteriological Evaluable) Population | Visit 1 (baseline, day -1~1) to Visit 3 (Within 24 hours after stopping the drug) | 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: 1. Subjects whose respiratory culture from visit 1 was positive; 2. 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. |
Countries
China, Taiwan
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Nemonoxacin 500 mg Nemonoxacin 500mg/250mL.
Nemonoxacin 500 mg: IV Infusion, once daily for 7\
14 days | 67 |
| Nemonoxacin 650 mg Nemonoxacin 650 mg/325mL
Nemonoxacin 650 mg: IV Infusion, once daily for 7\
14 days | 64 |
| Moxifloxacin 400 mg Moxifloxacin 400mg/250mL
Moxifloxacin 400 mg: IV Infusion, once daily for 7\
14 days | 64 |
| Total | 195 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 3 | 2 | 3 |
| Overall Study | Lack of Efficacy | 1 | 2 | 2 |
| Overall Study | Lost to Follow-up | 0 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 2 | 3 | 3 |
Baseline characteristics
| Characteristic | Nemonoxacin 500 mg | Nemonoxacin 650 mg | Moxifloxacin 400 mg | Total |
|---|---|---|---|---|
| Age, Continuous | 52.7 years STANDARD_DEVIATION 15.33 | 53.5 years STANDARD_DEVIATION 14.21 | 51.5 years STANDARD_DEVIATION 16 | 52.6 years STANDARD_DEVIATION 15.14 |
| Age, Customized ≧18 and <30 years | 6 participants | 4 participants | 10 participants | 20 participants |
| Age, Customized ≧30 and < 40 years | 9 participants | 8 participants | 9 participants | 26 participants |
| Age, Customized ≧40 and < 50 years | 10 participants | 12 participants | 8 participants | 30 participants |
| Age, Customized ≧50 and < 60 years | 16 participants | 15 participants | 11 participants | 42 participants |
| Age, Customized ≧60 and < 70 years | 16 participants | 17 participants | 17 participants | 50 participants |
| Age, Customized ≧70 and < 76 years | 10 participants | 8 participants | 9 participants | 27 participants |
| BMI | 22.5 kg/m^2 STANDARD_DEVIATION 3.01 | 23.4 kg/m^2 STANDARD_DEVIATION 3.44 | 23.6 kg/m^2 STANDARD_DEVIATION 3.29 | 23.1 kg/m^2 STANDARD_DEVIATION 3.27 |
| Drinking status Current drinker | 9 participants | 20 participants | 18 participants | 47 participants |
| Drinking status Former drinker | 4 participants | 3 participants | 7 participants | 14 participants |
| Drinking status Lifetime abstainer | 54 participants | 41 participants | 39 participants | 134 participants |
| Height | 163.5 cm STANDARD_DEVIATION 7.08 | 164.2 cm STANDARD_DEVIATION 8.65 | 164.7 cm STANDARD_DEVIATION 8.68 | 164.1 cm STANDARD_DEVIATION 8.13 |
| Nationality Han | 62 participants | 61 participants | 61 participants | 184 participants |
| Nationality Minority ethnic groups | 3 participants | 2 participants | 1 participants | 6 participants |
| Nationality Taiwan Aborigines | 0 participants | 0 participants | 1 participants | 1 participants |
| Nationality Unknown | 2 participants | 1 participants | 1 participants | 4 participants |
| PORT/PSI score Class II | 31 participants | 33 participants | 30 participants | 94 participants |
| PORT/PSI score Class III | 34 participants | 28 participants | 29 participants | 91 participants |
| PORT/PSI score Class IV | 2 participants | 3 participants | 5 participants | 10 participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 67 Participants | 64 Participants | 64 Participants | 195 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 25 Participants | 23 Participants | 23 Participants | 71 Participants |
| Sex: Female, Male Male | 42 Participants | 41 Participants | 41 Participants | 124 Participants |
| Smoking status Current smoker or smoked within the past 2 years | 14 participants | 24 participants | 17 participants | 55 participants |
| Smoking status Former smoker (abstinent for a minimum of 2 years) | 8 participants | 8 participants | 4 participants | 20 participants |
| Smoking status Never smoked | 45 participants | 32 participants | 43 participants | 120 participants |
| Weight | 60.0 kg STANDARD_DEVIATION 8.45 | 63.5 kg STANDARD_DEVIATION 12.94 | 64.3 kg STANDARD_DEVIATION 11.81 | 62.5 kg STANDARD_DEVIATION 11.29 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 51 / 68 | 41 / 67 | 33 / 70 |
| serious Total, serious adverse events | 3 / 68 | 1 / 67 | 1 / 70 |
Outcome results
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.
Time frame: Visit 1 (baseline, day -1~1) to Visit 4 (7-14 days after stopping the drug)
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nemonoxacin 500 mg | Difference in the Clinical Cure Rate of Two Doses of Intravenously Infused Nemonoxacin Malate Sodium Chloride Injection at Visit 4 in the mITT Population | Fail | 7 participants |
| Nemonoxacin 500 mg | Difference in the Clinical Cure Rate of Two Doses of Intravenously Infused Nemonoxacin Malate Sodium Chloride Injection at Visit 4 in the mITT Population | Success | 60 participants |
| Nemonoxacin 500 mg | Difference in the Clinical Cure Rate of Two Doses of Intravenously Infused Nemonoxacin Malate Sodium Chloride Injection at Visit 4 in the mITT Population | Not evaluable | 0 participants |
| Nemonoxacin 650 mg | Difference in the Clinical Cure Rate of Two Doses of Intravenously Infused Nemonoxacin Malate Sodium Chloride Injection at Visit 4 in the mITT Population | Fail | 4 participants |
| Nemonoxacin 650 mg | Difference in the Clinical Cure Rate of Two Doses of Intravenously Infused Nemonoxacin Malate Sodium Chloride Injection at Visit 4 in the mITT Population | Success | 58 participants |
| Nemonoxacin 650 mg | Difference in the Clinical Cure Rate of Two Doses of Intravenously Infused Nemonoxacin Malate Sodium Chloride Injection at Visit 4 in the mITT Population | Not evaluable | 2 participants |
| Moxifloxacin 400 mg | Difference in the Clinical Cure Rate of Two Doses of Intravenously Infused Nemonoxacin Malate Sodium Chloride Injection at Visit 4 in the mITT Population | Success | 59 participants |
| Moxifloxacin 400 mg | Difference in the Clinical Cure Rate of Two Doses of Intravenously Infused Nemonoxacin Malate Sodium Chloride Injection at Visit 4 in the mITT Population | Not evaluable | 3 participants |
| Moxifloxacin 400 mg | Difference in the Clinical Cure Rate of Two Doses of Intravenously Infused Nemonoxacin Malate Sodium Chloride Injection at Visit 4 in the mITT Population | Fail | 2 participants |
p-value: 0.13395% CI: [0.058, 1.457]Regression, Logistic
p-value: 0.42395% CI: [0.087, 2.788]Regression, Logistic
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.
Time frame: Visit 1 (baseline, day -1~1) to Visit 3 (Within 24 hours after stopping the drug)
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nemonoxacin 500 mg | Difference in the Clinical Cure Rate of Two Doses of Intravenously Infused Nemonoxacin Malate Sodium Chloride Injection at Visit 3 in the CE Population | Fail | 4 participants |
| Nemonoxacin 500 mg | Difference in the Clinical Cure Rate of Two Doses of Intravenously Infused Nemonoxacin Malate Sodium Chloride Injection at Visit 3 in the CE Population | Success | 58 participants |
| Nemonoxacin 500 mg | Difference in the Clinical Cure Rate of Two Doses of Intravenously Infused Nemonoxacin Malate Sodium Chloride Injection at Visit 3 in the CE Population | Not evaluable | 1 participants |
| Nemonoxacin 650 mg | Difference in the Clinical Cure Rate of Two Doses of Intravenously Infused Nemonoxacin Malate Sodium Chloride Injection at Visit 3 in the CE Population | Success | 56 participants |
| Nemonoxacin 650 mg | Difference in the Clinical Cure Rate of Two Doses of Intravenously Infused Nemonoxacin Malate Sodium Chloride Injection at Visit 3 in the CE Population | Fail | 3 participants |
| Nemonoxacin 650 mg | Difference in the Clinical Cure Rate of Two Doses of Intravenously Infused Nemonoxacin Malate Sodium Chloride Injection at Visit 3 in the CE Population | Not evaluable | 0 participants |
| Moxifloxacin 400 mg | Difference in the Clinical Cure Rate of Two Doses of Intravenously Infused Nemonoxacin Malate Sodium Chloride Injection at Visit 3 in the CE Population | Success | 56 participants |
| Moxifloxacin 400 mg | Difference in the Clinical Cure Rate of Two Doses of Intravenously Infused Nemonoxacin Malate Sodium Chloride Injection at Visit 3 in the CE Population | Not evaluable | 2 participants |
| Moxifloxacin 400 mg | Difference in the Clinical Cure Rate of Two Doses of Intravenously Infused Nemonoxacin Malate Sodium Chloride Injection at Visit 3 in the CE Population | Fail | 2 participants |
p-value: 0.66495% CI: [0.107, 4.144]Regression, Logistic
p-value: 0.45895% CI: [0.091, 2.941]Regression, Logistic
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.
Time frame: Visit 1 (baseline, day -1~1) to Visit 3 (Within 24 hours after stopping the drug)
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nemonoxacin 500 mg | Difference in the Clinical Cure Rate of Two Doses of Intravenously Infused Nemonoxacin Malate Sodium Chloride Injection at Visit 3 in the mITT Population | Fail | 4 participants |
| Nemonoxacin 500 mg | Difference in the Clinical Cure Rate of Two Doses of Intravenously Infused Nemonoxacin Malate Sodium Chloride Injection at Visit 3 in the mITT Population | Success | 61 participants |
| Nemonoxacin 500 mg | Difference in the Clinical Cure Rate of Two Doses of Intravenously Infused Nemonoxacin Malate Sodium Chloride Injection at Visit 3 in the mITT Population | Not evaluable | 2 participants |
| Nemonoxacin 650 mg | Difference in the Clinical Cure Rate of Two Doses of Intravenously Infused Nemonoxacin Malate Sodium Chloride Injection at Visit 3 in the mITT Population | Fail | 4 participants |
| Nemonoxacin 650 mg | Difference in the Clinical Cure Rate of Two Doses of Intravenously Infused Nemonoxacin Malate Sodium Chloride Injection at Visit 3 in the mITT Population | Success | 60 participants |
| Nemonoxacin 650 mg | Difference in the Clinical Cure Rate of Two Doses of Intravenously Infused Nemonoxacin Malate Sodium Chloride Injection at Visit 3 in the mITT Population | Not evaluable | 0 participants |
| Moxifloxacin 400 mg | Difference in the Clinical Cure Rate of Two Doses of Intravenously Infused Nemonoxacin Malate Sodium Chloride Injection at Visit 3 in the mITT Population | Success | 59 participants |
| Moxifloxacin 400 mg | Difference in the Clinical Cure Rate of Two Doses of Intravenously Infused Nemonoxacin Malate Sodium Chloride Injection at Visit 3 in the mITT Population | Not evaluable | 3 participants |
| Moxifloxacin 400 mg | Difference in the Clinical Cure Rate of Two Doses of Intravenously Infused Nemonoxacin Malate Sodium Chloride Injection at Visit 3 in the mITT Population | Fail | 2 participants |
p-value: 0.45695% CI: [0.091, 2.93]Regression, Logistic
p-value: 0.44595% CI: [0.09, 2.883]Regression, Logistic
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.
Time frame: Visit 1 (baseline, day -1~1) to Visit 4 (7-14 days after stopping the drug)
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nemonoxacin 500 mg | 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 | Not evaluable | 7 participants |
| Nemonoxacin 500 mg | 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 | Success | 56 participants |
| Nemonoxacin 650 mg | 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 | Success | 56 participants |
| Nemonoxacin 650 mg | 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 | Not evaluable | 3 participants |
| Moxifloxacin 400 mg | 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 | Success | 58 participants |
| Moxifloxacin 400 mg | 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 | Not evaluable | 2 participants |
p-value: 0.11895% CI: [0.055, 1.385]Regression, Logistic
p-value: 0.63695% CI: [0.104, 3.999]Regression, Logistic
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: 1. Subjects whose respiratory culture from visit 1 was positive; 2. 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)
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nemonoxacin 500 mg | Subject Number for Microbiologically Cured and Failure at Visit 3 in BE (Bacteriological Evaluable) Population | Not evaluable | 0 participants |
| Nemonoxacin 500 mg | Subject Number for Microbiologically Cured and Failure at Visit 3 in BE (Bacteriological Evaluable) Population | Failure | 2 participants |
| Nemonoxacin 500 mg | Subject Number for Microbiologically Cured and Failure at Visit 3 in BE (Bacteriological Evaluable) Population | Success | 21 participants |
| Nemonoxacin 650 mg | Subject Number for Microbiologically Cured and Failure at Visit 3 in BE (Bacteriological Evaluable) Population | Failure | 1 participants |
| Nemonoxacin 650 mg | Subject Number for Microbiologically Cured and Failure at Visit 3 in BE (Bacteriological Evaluable) Population | Success | 18 participants |
| Nemonoxacin 650 mg | Subject Number for Microbiologically Cured and Failure at Visit 3 in BE (Bacteriological Evaluable) Population | Not evaluable | 0 participants |
| Moxifloxacin 400 mg | Subject Number for Microbiologically Cured and Failure at Visit 3 in BE (Bacteriological Evaluable) Population | Success | 16 participants |
| Moxifloxacin 400 mg | Subject Number for Microbiologically Cured and Failure at Visit 3 in BE (Bacteriological Evaluable) Population | Not evaluable | 0 participants |
| Moxifloxacin 400 mg | Subject Number for Microbiologically Cured and Failure at Visit 3 in BE (Bacteriological Evaluable) Population | Failure | 0 participants |
p-value: 0.949Regression, Logistic
p-value: 0.962Regression, Logistic
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: 1. Subjects whose respiratory culture from visit 1 was positive; 2. 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)
Population: Subjects in the mITT population whose bacterial culture yielded at least one baseline bacterial isolate were enrolled into the b-mITT population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nemonoxacin 500 mg | Subject Number for Microbiologically Cured and Failure at Visit 3 in b-mITT (Bacteriological mITT) Population | Failure | 2 participants |
| Nemonoxacin 500 mg | Subject Number for Microbiologically Cured and Failure at Visit 3 in b-mITT (Bacteriological mITT) Population | Success | 22 participants |
| Nemonoxacin 500 mg | Subject Number for Microbiologically Cured and Failure at Visit 3 in b-mITT (Bacteriological mITT) Population | Not evaluable | 0 participants |
| Nemonoxacin 650 mg | Subject Number for Microbiologically Cured and Failure at Visit 3 in b-mITT (Bacteriological mITT) Population | Failure | 1 participants |
| Nemonoxacin 650 mg | Subject Number for Microbiologically Cured and Failure at Visit 3 in b-mITT (Bacteriological mITT) Population | Success | 18 participants |
| Nemonoxacin 650 mg | Subject Number for Microbiologically Cured and Failure at Visit 3 in b-mITT (Bacteriological mITT) Population | Not evaluable | 0 participants |
| Moxifloxacin 400 mg | Subject Number for Microbiologically Cured and Failure at Visit 3 in b-mITT (Bacteriological mITT) Population | Success | 16 participants |
| Moxifloxacin 400 mg | Subject Number for Microbiologically Cured and Failure at Visit 3 in b-mITT (Bacteriological mITT) Population | Not evaluable | 1 participants |
| Moxifloxacin 400 mg | Subject Number for Microbiologically Cured and Failure at Visit 3 in b-mITT (Bacteriological mITT) Population | Failure | 0 participants |
p-value: 0.95Regression, Logistic
p-value: 0.962Regression, Logistic
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: 1. Subjects whose respiratory culture from visit 1 was positive; 2. 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)
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nemonoxacin 500 mg | Subject Number for Microbiologically Cured and Failure at Visit 4 in BE (Bacteriological Evaluable) Population | Failure | 3 participants |
| Nemonoxacin 500 mg | Subject Number for Microbiologically Cured and Failure at Visit 4 in BE (Bacteriological Evaluable) Population | Success | 20 participants |
| Nemonoxacin 500 mg | Subject Number for Microbiologically Cured and Failure at Visit 4 in BE (Bacteriological Evaluable) Population | Not evaluable | 0 participants |
| Nemonoxacin 650 mg | Subject Number for Microbiologically Cured and Failure at Visit 4 in BE (Bacteriological Evaluable) Population | Failure | 1 participants |
| Nemonoxacin 650 mg | Subject Number for Microbiologically Cured and Failure at Visit 4 in BE (Bacteriological Evaluable) Population | Success | 17 participants |
| Nemonoxacin 650 mg | Subject Number for Microbiologically Cured and Failure at Visit 4 in BE (Bacteriological Evaluable) Population | Not evaluable | 1 participants |
| Moxifloxacin 400 mg | Subject Number for Microbiologically Cured and Failure at Visit 4 in BE (Bacteriological Evaluable) Population | Success | 15 participants |
| Moxifloxacin 400 mg | Subject Number for Microbiologically Cured and Failure at Visit 4 in BE (Bacteriological Evaluable) Population | Not evaluable | 1 participants |
| Moxifloxacin 400 mg | Subject Number for Microbiologically Cured and Failure at Visit 4 in BE (Bacteriological Evaluable) Population | Failure | 0 participants |
p-value: 0.96Regression, Logistic
p-value: 0.962Regression, Logistic
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: 1. Subjects whose respiratory culture from visit 1 was positive; 2. 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)
Population: Subjects in the mITT population whose bacterial culture yielded at least one baseline bacterial isolate were enrolled into the b-mITT population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nemonoxacin 500 mg | Subject Number for Microbiologically Cured and Failure at Visit 4 in b-mITT (Bacteriological mITT) Population | Failure | 3 participants |
| Nemonoxacin 500 mg | Subject Number for Microbiologically Cured and Failure at Visit 4 in b-mITT (Bacteriological mITT) Population | Success | 21 participants |
| Nemonoxacin 500 mg | Subject Number for Microbiologically Cured and Failure at Visit 4 in b-mITT (Bacteriological mITT) Population | Not evaluable | 0 participants |
| Nemonoxacin 650 mg | Subject Number for Microbiologically Cured and Failure at Visit 4 in b-mITT (Bacteriological mITT) Population | Failure | 1 participants |
| Nemonoxacin 650 mg | Subject Number for Microbiologically Cured and Failure at Visit 4 in b-mITT (Bacteriological mITT) Population | Success | 17 participants |
| Nemonoxacin 650 mg | Subject Number for Microbiologically Cured and Failure at Visit 4 in b-mITT (Bacteriological mITT) Population | Not evaluable | 1 participants |
| Moxifloxacin 400 mg | Subject Number for Microbiologically Cured and Failure at Visit 4 in b-mITT (Bacteriological mITT) Population | Success | 16 participants |
| Moxifloxacin 400 mg | Subject Number for Microbiologically Cured and Failure at Visit 4 in b-mITT (Bacteriological mITT) Population | Not evaluable | 1 participants |
| Moxifloxacin 400 mg | Subject Number for Microbiologically Cured and Failure at Visit 4 in b-mITT (Bacteriological mITT) Population | Failure | 0 participants |
p-value: 0.959Regression, Logistic
p-value: 0.961Regression, Logistic
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.
Time frame: Visit 1 (baseline, day -1~1) to Visit 3 (Within 24 hours after stopping the drug)
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nemonoxacin 500 mg | Subject Number of Success and Failure in Overall Efficacy at Visit 3 in BE (Bacteriological Evaluable) Population | Success | 21 participants |
| Nemonoxacin 500 mg | Subject Number of Success and Failure in Overall Efficacy at Visit 3 in BE (Bacteriological Evaluable) Population | Failure | 2 participants |
| Nemonoxacin 650 mg | Subject Number of Success and Failure in Overall Efficacy at Visit 3 in BE (Bacteriological Evaluable) Population | Success | 17 participants |
| Nemonoxacin 650 mg | Subject Number of Success and Failure in Overall Efficacy at Visit 3 in BE (Bacteriological Evaluable) Population | Failure | 2 participants |
| Moxifloxacin 400 mg | Subject Number of Success and Failure in Overall Efficacy at Visit 3 in BE (Bacteriological Evaluable) Population | Success | 15 participants |
| Moxifloxacin 400 mg | Subject Number of Success and Failure in Overall Efficacy at Visit 3 in BE (Bacteriological Evaluable) Population | Failure | 1 participants |
p-value: 0.77995% CI: [0.058, 8.445]Regression, Logistic
p-value: 0.65695% CI: [0.047, 6.895]Regression, Logistic
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.
Time frame: Visit 1 (baseline, day -1~1) to Visit 3 (Within 24 hours after stopping the drug)
Population: Subjects in the mITT population whose bacterial culture yielded at least one baseline bacterial isolate were enrolled into the b-mITT population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nemonoxacin 500 mg | Subject Number of Success and Failure in Overall Efficacy at Visit 3 in b-mITT (Bacteriological mITT) Population | Unevaluable | 0 participants |
| Nemonoxacin 500 mg | Subject Number of Success and Failure in Overall Efficacy at Visit 3 in b-mITT (Bacteriological mITT) Population | Success | 22 participants |
| Nemonoxacin 500 mg | Subject Number of Success and Failure in Overall Efficacy at Visit 3 in b-mITT (Bacteriological mITT) Population | Failure | 2 participants |
| Nemonoxacin 650 mg | Subject Number of Success and Failure in Overall Efficacy at Visit 3 in b-mITT (Bacteriological mITT) Population | Unevaluable | 0 participants |
| Nemonoxacin 650 mg | Subject Number of Success and Failure in Overall Efficacy at Visit 3 in b-mITT (Bacteriological mITT) Population | Success | 17 participants |
| Nemonoxacin 650 mg | Subject Number of Success and Failure in Overall Efficacy at Visit 3 in b-mITT (Bacteriological mITT) Population | Failure | 2 participants |
| Moxifloxacin 400 mg | Subject Number of Success and Failure in Overall Efficacy at Visit 3 in b-mITT (Bacteriological mITT) Population | Unevaluable | 1 participants |
| Moxifloxacin 400 mg | Subject Number of Success and Failure in Overall Efficacy at Visit 3 in b-mITT (Bacteriological mITT) Population | Success | 15 participants |
| Moxifloxacin 400 mg | Subject Number of Success and Failure in Overall Efficacy at Visit 3 in b-mITT (Bacteriological mITT) Population | Failure | 1 participants |
p-value: 0.80795% CI: [0.061, 8.832]Regression, Logistic
p-value: 0.65695% CI: [0.047, 6.895]Regression, Logistic
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.
Time frame: Visit 1 (baseline, day -1~1) to Visit 4 (7-14 days after stopping the drug)
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nemonoxacin 500 mg | Subject Number of Success and Failure in Overall Efficacy at Visit 4 in BE (Bacteriological Evaluable) Population | Success | 20 participants |
| Nemonoxacin 500 mg | Subject Number of Success and Failure in Overall Efficacy at Visit 4 in BE (Bacteriological Evaluable) Population | Failure | 3 participants |
| Nemonoxacin 650 mg | Subject Number of Success and Failure in Overall Efficacy at Visit 4 in BE (Bacteriological Evaluable) Population | Success | 17 participants |
| Nemonoxacin 650 mg | Subject Number of Success and Failure in Overall Efficacy at Visit 4 in BE (Bacteriological Evaluable) Population | Failure | 2 participants |
| Moxifloxacin 400 mg | Subject Number of Success and Failure in Overall Efficacy at Visit 4 in BE (Bacteriological Evaluable) Population | Success | 15 participants |
| Moxifloxacin 400 mg | Subject Number of Success and Failure in Overall Efficacy at Visit 4 in BE (Bacteriological Evaluable) Population | Failure | 1 participants |
p-value: 0.50195% CI: [0.042, 4.708]Regression, Logistic
p-value: 0.65695% CI: [0.047, 6.895]Regression, Logistic
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.
Time frame: Visit 1 (baseline, day -1~1) to Visit 4 (7-14 days after stopping the drug)
Population: Subjects in the mITT population whose bacterial culture yielded at least one baseline bacterial isolate were enrolled into the b-mITT population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nemonoxacin 500 mg | Subject Number of Success and Failure in Overall Efficacy at Visit 4 in b-mITT (Bacteriological mITT) Population | Success | 21 participants |
| Nemonoxacin 500 mg | Subject Number of Success and Failure in Overall Efficacy at Visit 4 in b-mITT (Bacteriological mITT) Population | Failure | 3 participants |
| Nemonoxacin 650 mg | Subject Number of Success and Failure in Overall Efficacy at Visit 4 in b-mITT (Bacteriological mITT) Population | Success | 17 participants |
| Nemonoxacin 650 mg | Subject Number of Success and Failure in Overall Efficacy at Visit 4 in b-mITT (Bacteriological mITT) Population | Failure | 2 participants |
| Moxifloxacin 400 mg | Subject Number of Success and Failure in Overall Efficacy at Visit 4 in b-mITT (Bacteriological mITT) Population | Success | 16 participants |
| Moxifloxacin 400 mg | Subject Number of Success and Failure in Overall Efficacy at Visit 4 in b-mITT (Bacteriological mITT) Population | Failure | 1 participants |
p-value: 0.49195% CI: [0.042, 4.609]Regression, Logistic
p-value: 0.61995% CI: [0.044, 6.444]Regression, Logistic