Gram-Positive Bacterial Infections, Skin and Subcutaneous Tissue Bacterial Infections
Conditions
Keywords
TNP-2092, ABSSSI, Safety, Efficacy
Brief summary
The purpose of this study is to evaluate safety, tolerability, pharmacokinetic characteristics and efficacy of TNP-2092 in adults with ABSSSI suspected or confirmed to be caused by gram-positive pathogens.
Detailed description
This Phase 2, double-blind, randomized, multicenter, parallel, controlled study is conducted to evaluate safety, tolerability, pharmacokinetics and efficacy of TNP-2092, and vancomycin in adults with ABSSSI suspected or confirmed to be caused by gram-positive pathogens. The duration of the treatment period is a minimum of 7 days and a maximum of 14 days.
Interventions
DRUGTNP-2092
TNP-2092 100mg/vial
DRUGVancomycin
Vancomycin 1g/vial
Sponsors
TenNor Therapeutics Limited
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
TNP-2092 300 mg intravenous every 12 hours vancomycin 1 g intravenous every 12 hours
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects may be included in the study if they meet all of the following inclusion criteria: * Males or females, 18 years of age or older; * ABSSSI suspected or confirmed to be caused by gram-positive pathogens, including: * Cellulitis/erysipelas; * Wound infection; * Major cutaneous abscess; * Lesion with a minimum surface area of 75 cm2; * Capable of giving signed informed consent.
Exclusion criteria
* Subjects will be excluded from the study if any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Early Clinical Response at the Early Assessment (EA) Visit in the Intent-to-Treat (ITT) Population | 48 to 72 hours after the first dose of study treatment | Early clinical response is defined as responder meeting two criteria: (1) patient had at least a 20% reduction of acute bacterial skin and skin structure infection (ABSSSI) primary lesion size compared to baseline measurements; (2) patient did not die of any cause within 72 hours of the first dose of study treatment. An indeterminate classification is used for a response that could not be adequately inferred because study data are unavailable for evaluation of efficacy for any reason (eg, missing data, lost to follow-up, did not attend the EA clinic appointment), or if the early assessment visit is out of the 48 to 72 hours window after the intravenous study treatment starts. |
| Early Clinical Response at the Early Assessment Visit in the Modified Intent-to-Treat (mITT) Population | 48 to 72 hours after the first dose of study treatment | Early clinical response is defined as responder meeting two criteria: (1) patient had at least a 20% reduction of acute bacterial skin and skin structure infection (ABSSSI) primary lesion size compared to baseline measurements; (2) patient did not die of any cause within 72 hours of the first dose of study treatment. An indeterminate classification is used for a response that could not be adequately inferred because study data are unavailable for evaluation of efficacy for any reason (eg, missing data, lost to follow-up, did not attend the EA clinic appointment), or if the early assessment visit is out of the 48 to 72 hours window after the intravenous study treatment starts. |
| Early Clinical Response at the Early Assessment Visit in the Micro-Intent-to-Treat (Micro-ITT) Population | 48 to 72 hours after the first dose of study treatment | Early clinical response is defined as responder meeting two criteria: (1) patient had at least a 20% reduction of acute bacterial skin and skin structure infection (ABSSSI) primary lesion size compared to baseline measurements; (2) patient did not die of any cause within 72 hours of the first dose of study treatment. An indeterminate classification is used for a response that could not be adequately inferred because study data are unavailable for evaluation of efficacy for any reason (eg, missing data, lost to follow-up, did not attend the EA clinic appointment), or if the early assessment visit is out of the 48 to 72 hours window after the intravenous study treatment starts. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Investigator's Assessment of Clinical Response at the End of Treatment (EOT) Visit in the Micro-ITT Population | After a minimum of 7 days up to 14 days of study treatment | At the EOT Visit the investigator indicated one of the following outcomes relating to the primary infection under study: Clinical Success: participant was alive; the ABSSSI sufficiently resolved such that further antibacterial therapy is not needed. Clinical Failure: any of the following: (1)Investigator discontinued study treatment and indicated that the ABSSSI had responded inadequately such that alternative (rescue) non-study antibacterial therapy was needed; (2)participant received antibacterial therapy for a different infection that may be effective for the ABSSSI under study; (3) participant developed an adverse event (AE) that required discontinuation of study treatment before completion of the planned treatment regimen; (4) unplanned major surgical treatment for the ABSSSI under study; (5) participant died of any cause up to the specified visit. Indeterminate: study data are unavailable for evaluation of efficacy for any reason (eg, missing data, lost to follow-up). |
| AUC0-12h After First Infusion | 0 to 12 hours post-dose | Partial area under the concentration versus time curve from time zero to time 12 hours. |
| Investigator Assessment of Clinical Response at Post Treatment Evaluation (PTE) Visit in the mITT Population | 7 to 14 days after the end of study treatment | At the PTE Visit the investigator indicated one of the following outcomes relating to the primary infection under study: Clinical Success: participant was alive; the ABSSSI sufficiently resolved such that further antibacterial therapy is not needed. Clinical Failure: any of the following: (1)Investigator discontinued study treatment and indicated that the ABSSSI had responded inadequately such that alternative (rescue) non-study antibacterial therapy was needed; (2)participant received antibacterial therapy for a different infection that may be effective for the ABSSSI under study; (3) participant developed an adverse event (AE) that required discontinuation of study treatment before completion of the planned treatment regimen; (4) unplanned major surgical treatment for the ABSSSI under study; (5) participant died of any cause up to the specified visit. Indeterminate: study data are unavailable for evaluation of efficacy for any reason (eg, missing data, lost to follow-up). |
| Cmax After Last Infusion | 57 to 60 minutes, 1.5 to 3 hours, 4 to 6 hours, 12 hours, after the last infusion | Maximum observed concentration |
| Cmax After First Infusion | 57 to 60 minutes, 1.5 to 3 hours, 4 to 6 hours, 12 hours, after the first infusion | Maximum observed concentration |
| AUC0-12h After Last Infusion | 0 to 12 hours post-dose | Partial area under the concentration versus time curve from time zero to time 12 hours |
| Investigator Assessment of Clinical Response at Post Treatment Evaluation (PTE) Visit in the Micro-ITT Population | 7 to 14 days after the end of study treatment | At the PTE Visit the investigator indicated one of the following outcomes relating to the primary infection under study: Clinical Success: participant was alive; the ABSSSI sufficiently resolved such that further antibacterial therapy is not needed. Clinical Failure: any of the following: (1)Investigator discontinued study treatment and indicated that the ABSSSI had responded inadequately such that alternative (rescue) non-study antibacterial therapy was needed; (2)participant received antibacterial therapy for a different infection that may be effective for the ABSSSI under study; (3) participant developed an adverse event (AE) that required discontinuation of study treatment before completion of the planned treatment regimen; (4) unplanned major surgical treatment for the ABSSSI under study; (5) participant died of any cause up to the specified visit. Indeterminate: study data are unavailable for evaluation of efficacy for any reason (eg, missing data, lost to follow-up). |
| Investigator's Assessment of Clinical Response at the End of Treatment (EOT) Visit in the mITT Population | After a minimum of 7 days up to 14 days of study treatment | At the EOT Visit the investigator indicated one of the following outcomes relating to the primary infection under study: Clinical Success: participant was alive; the ABSSSI sufficiently resolved such that further antibacterial therapy is not needed. Clinical Failure: any of the following: (1)Investigator discontinued study treatment and indicated that the ABSSSI had responded inadequately such that alternative (rescue) non-study antibacterial therapy was needed; (2)participant received antibacterial therapy for a different infection that may be effective for the ABSSSI under study; (3) participant developed an adverse event (AE) that required discontinuation of study treatment before completion of the planned treatment regimen; (4) unplanned major surgical treatment for the ABSSSI under study; (5) participant died of any cause up to the specified visit. Indeterminate: study data are unavailable for evaluation of efficacy for any reason (eg, missing data, lost to follow-up). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| TNP-2092 TNP-2092 300 mg intravenous every 12 hours
TNP-2092: TNP-2092 100mg/vial | 80 |
| Vancomycin vancomycin 1 g intravenous every 12 hours
Vancomycin: Vancomycin 1g/vial | 40 |
| Total | 120 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 13 | 4 |
| Overall Study | Withdrawal by Subject | 4 | 1 |
Baseline characteristics
| Characteristic | TNP-2092 | Vancomycin | Total |
|---|---|---|---|
| Age, Continuous | 41.4 years STANDARD_DEVIATION 11.72 | 42.7 years STANDARD_DEVIATION 13.16 | 41.9 years STANDARD_DEVIATION 12.18 |
| Body mass index | 24.1 kg/m^2 STANDARD_DEVIATION 2.98 | 24.8 kg/m^2 STANDARD_DEVIATION 3.47 | 24.4 kg/m^2 STANDARD_DEVIATION 3.15 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 32 Participants | 17 Participants | 49 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 48 Participants | 23 Participants | 71 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Height | 173.5 cm STANDARD_DEVIATION 9.46 | 170.5 cm STANDARD_DEVIATION 8.32 | 172.5 cm STANDARD_DEVIATION 9.17 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 3 Participants | 4 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 4 Participants | 9 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants | 1 Participants | 5 Participants |
| Race (NIH/OMB) White | 70 Participants | 32 Participants | 102 Participants |
| Sex: Female, Male Female | 19 Participants | 14 Participants | 33 Participants |
| Sex: Female, Male Male | 61 Participants | 26 Participants | 87 Participants |
| Weight | 72.8 kg STANDARD_DEVIATION 11.81 | 72.7 kg STANDARD_DEVIATION 14.43 | 72.8 kg STANDARD_DEVIATION 12.68 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 78 | 0 / 39 |
| other Total, other adverse events | 27 / 78 | 11 / 39 |
| serious Total, serious adverse events | 1 / 78 | 2 / 39 |
Outcome results
Primary
Early Clinical Response at the Early Assessment (EA) Visit in the Intent-to-Treat (ITT) Population
Early clinical response is defined as responder meeting two criteria: (1) patient had at least a 20% reduction of acute bacterial skin and skin structure infection (ABSSSI) primary lesion size compared to baseline measurements; (2) patient did not die of any cause within 72 hours of the first dose of study treatment. An indeterminate classification is used for a response that could not be adequately inferred because study data are unavailable for evaluation of efficacy for any reason (eg, missing data, lost to follow-up, did not attend the EA clinic appointment), or if the early assessment visit is out of the 48 to 72 hours window after the intravenous study treatment starts.
Time frame: 48 to 72 hours after the first dose of study treatment
Population: Intent-to-Treat (mITT) Population: all randomized participants.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| TNP-2092 | Early Clinical Response at the Early Assessment (EA) Visit in the Intent-to-Treat (ITT) Population | Responder | 61 Participants |
| TNP-2092 | Early Clinical Response at the Early Assessment (EA) Visit in the Intent-to-Treat (ITT) Population | Nonresponder | 4 Participants |
| TNP-2092 | Early Clinical Response at the Early Assessment (EA) Visit in the Intent-to-Treat (ITT) Population | Indeterminate | 15 Participants |
| Vancomycin | Early Clinical Response at the Early Assessment (EA) Visit in the Intent-to-Treat (ITT) Population | Responder | 27 Participants |
| Vancomycin | Early Clinical Response at the Early Assessment (EA) Visit in the Intent-to-Treat (ITT) Population | Nonresponder | 3 Participants |
| Vancomycin | Early Clinical Response at the Early Assessment (EA) Visit in the Intent-to-Treat (ITT) Population | Indeterminate | 10 Participants |
Primary
Early Clinical Response at the Early Assessment Visit in the Micro-Intent-to-Treat (Micro-ITT) Population
Early clinical response is defined as responder meeting two criteria: (1) patient had at least a 20% reduction of acute bacterial skin and skin structure infection (ABSSSI) primary lesion size compared to baseline measurements; (2) patient did not die of any cause within 72 hours of the first dose of study treatment. An indeterminate classification is used for a response that could not be adequately inferred because study data are unavailable for evaluation of efficacy for any reason (eg, missing data, lost to follow-up, did not attend the EA clinic appointment), or if the early assessment visit is out of the 48 to 72 hours window after the intravenous study treatment starts.
Time frame: 48 to 72 hours after the first dose of study treatment
Population: Micro-Intent-to-Treat (mITT) Population: all randomized participants in the mITT population with culture evidence of a baseline gram-positive ABSSSI pathogens (exclude sole gram negative and culture-negative participants)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| TNP-2092 | Early Clinical Response at the Early Assessment Visit in the Micro-Intent-to-Treat (Micro-ITT) Population | Responder | 41 Participants |
| TNP-2092 | Early Clinical Response at the Early Assessment Visit in the Micro-Intent-to-Treat (Micro-ITT) Population | Nonresponder | 3 Participants |
| TNP-2092 | Early Clinical Response at the Early Assessment Visit in the Micro-Intent-to-Treat (Micro-ITT) Population | Indeterminate | 7 Participants |
| Vancomycin | Early Clinical Response at the Early Assessment Visit in the Micro-Intent-to-Treat (Micro-ITT) Population | Responder | 19 Participants |
| Vancomycin | Early Clinical Response at the Early Assessment Visit in the Micro-Intent-to-Treat (Micro-ITT) Population | Nonresponder | 2 Participants |
| Vancomycin | Early Clinical Response at the Early Assessment Visit in the Micro-Intent-to-Treat (Micro-ITT) Population | Indeterminate | 8 Participants |
Primary
Early Clinical Response at the Early Assessment Visit in the Modified Intent-to-Treat (mITT) Population
Early clinical response is defined as responder meeting two criteria: (1) patient had at least a 20% reduction of acute bacterial skin and skin structure infection (ABSSSI) primary lesion size compared to baseline measurements; (2) patient did not die of any cause within 72 hours of the first dose of study treatment. An indeterminate classification is used for a response that could not be adequately inferred because study data are unavailable for evaluation of efficacy for any reason (eg, missing data, lost to follow-up, did not attend the EA clinic appointment), or if the early assessment visit is out of the 48 to 72 hours window after the intravenous study treatment starts.
Time frame: 48 to 72 hours after the first dose of study treatment
Population: Modified Intent-to-Treat (mITT) Population: all randomized participants in the ITT population excluding those who have gram-negative pathogens only
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| TNP-2092 | Early Clinical Response at the Early Assessment Visit in the Modified Intent-to-Treat (mITT) Population | Responder | 60 Participants |
| TNP-2092 | Early Clinical Response at the Early Assessment Visit in the Modified Intent-to-Treat (mITT) Population | Nonresponder | 4 Participants |
| TNP-2092 | Early Clinical Response at the Early Assessment Visit in the Modified Intent-to-Treat (mITT) Population | Indeterminate | 14 Participants |
| Vancomycin | Early Clinical Response at the Early Assessment Visit in the Modified Intent-to-Treat (mITT) Population | Responder | 27 Participants |
| Vancomycin | Early Clinical Response at the Early Assessment Visit in the Modified Intent-to-Treat (mITT) Population | Nonresponder | 3 Participants |
| Vancomycin | Early Clinical Response at the Early Assessment Visit in the Modified Intent-to-Treat (mITT) Population | Indeterminate | 10 Participants |
Secondary
AUC0-12h After First Infusion
Partial area under the concentration versus time curve from time zero to time 12 hours.
Time frame: 0 to 12 hours post-dose
Population: Participants that have sufficient plasma points for AUC 0-12h after first infusion analysis (26 Participants).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TNP-2092 | AUC0-12h After First Infusion | 135000 h*ng/mL | Standard Deviation 38200 |
Secondary
AUC0-12h After Last Infusion
Partial area under the concentration versus time curve from time zero to time 12 hours
Time frame: 0 to 12 hours post-dose
Population: Participants that have sufficient plasma points for AUC 0-12h after last infusion analysis (39 Participants)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TNP-2092 | AUC0-12h After Last Infusion | 159000 h*ng/mL | Standard Deviation 74200 |
Secondary
Cmax After First Infusion
Maximum observed concentration
Time frame: 57 to 60 minutes, 1.5 to 3 hours, 4 to 6 hours, 12 hours, after the first infusion
Population: Participants that have sufficient plasma points for Cmax after first infusion analysis (68 Participants)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TNP-2092 | Cmax After First Infusion | 37500 ng/mL | Standard Deviation 13500 |
Secondary
Cmax After Last Infusion
Maximum observed concentration
Time frame: 57 to 60 minutes, 1.5 to 3 hours, 4 to 6 hours, 12 hours, after the last infusion
Population: Participants that have sufficient plasma points for Cmax after last infusion analysis (58 Participants)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TNP-2092 | Cmax After Last Infusion | 38500 ng/mL | Standard Deviation 13400 |
Secondary
Investigator Assessment of Clinical Response at Post Treatment Evaluation (PTE) Visit in the Micro-ITT Population
At the PTE Visit the investigator indicated one of the following outcomes relating to the primary infection under study: Clinical Success: participant was alive; the ABSSSI sufficiently resolved such that further antibacterial therapy is not needed. Clinical Failure: any of the following: (1)Investigator discontinued study treatment and indicated that the ABSSSI had responded inadequately such that alternative (rescue) non-study antibacterial therapy was needed; (2)participant received antibacterial therapy for a different infection that may be effective for the ABSSSI under study; (3) participant developed an adverse event (AE) that required discontinuation of study treatment before completion of the planned treatment regimen; (4) unplanned major surgical treatment for the ABSSSI under study; (5) participant died of any cause up to the specified visit. Indeterminate: study data are unavailable for evaluation of efficacy for any reason (eg, missing data, lost to follow-up).
Time frame: 7 to 14 days after the end of study treatment
Population: Micro-Intent-to-Treat (mITT) Population: all randomized participants in the mITT population with culture evidence of a baseline gram-positive ABSSSI pathogens (exclude sole gram negative and culture-negative participants)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| TNP-2092 | Investigator Assessment of Clinical Response at Post Treatment Evaluation (PTE) Visit in the Micro-ITT Population | Success | 40 Participants |
| TNP-2092 | Investigator Assessment of Clinical Response at Post Treatment Evaluation (PTE) Visit in the Micro-ITT Population | Failure | 2 Participants |
| TNP-2092 | Investigator Assessment of Clinical Response at Post Treatment Evaluation (PTE) Visit in the Micro-ITT Population | Indeterminate | 9 Participants |
| Vancomycin | Investigator Assessment of Clinical Response at Post Treatment Evaluation (PTE) Visit in the Micro-ITT Population | Success | 23 Participants |
| Vancomycin | Investigator Assessment of Clinical Response at Post Treatment Evaluation (PTE) Visit in the Micro-ITT Population | Failure | 1 Participants |
| Vancomycin | Investigator Assessment of Clinical Response at Post Treatment Evaluation (PTE) Visit in the Micro-ITT Population | Indeterminate | 5 Participants |
Secondary
Investigator Assessment of Clinical Response at Post Treatment Evaluation (PTE) Visit in the mITT Population
At the PTE Visit the investigator indicated one of the following outcomes relating to the primary infection under study: Clinical Success: participant was alive; the ABSSSI sufficiently resolved such that further antibacterial therapy is not needed. Clinical Failure: any of the following: (1)Investigator discontinued study treatment and indicated that the ABSSSI had responded inadequately such that alternative (rescue) non-study antibacterial therapy was needed; (2)participant received antibacterial therapy for a different infection that may be effective for the ABSSSI under study; (3) participant developed an adverse event (AE) that required discontinuation of study treatment before completion of the planned treatment regimen; (4) unplanned major surgical treatment for the ABSSSI under study; (5) participant died of any cause up to the specified visit. Indeterminate: study data are unavailable for evaluation of efficacy for any reason (eg, missing data, lost to follow-up).
Time frame: 7 to 14 days after the end of study treatment
Population: Modified Intent-to-Treat (mITT) Population: all randomized participants in the ITT population excluding those who have gram-negative pathogens only
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| TNP-2092 | Investigator Assessment of Clinical Response at Post Treatment Evaluation (PTE) Visit in the mITT Population | Success | 62 Participants |
| TNP-2092 | Investigator Assessment of Clinical Response at Post Treatment Evaluation (PTE) Visit in the mITT Population | Failure | 2 Participants |
| TNP-2092 | Investigator Assessment of Clinical Response at Post Treatment Evaluation (PTE) Visit in the mITT Population | Indeterminate | 14 Participants |
| Vancomycin | Investigator Assessment of Clinical Response at Post Treatment Evaluation (PTE) Visit in the mITT Population | Success | 31 Participants |
| Vancomycin | Investigator Assessment of Clinical Response at Post Treatment Evaluation (PTE) Visit in the mITT Population | Failure | 3 Participants |
| Vancomycin | Investigator Assessment of Clinical Response at Post Treatment Evaluation (PTE) Visit in the mITT Population | Indeterminate | 6 Participants |
Secondary
Investigator's Assessment of Clinical Response at the End of Treatment (EOT) Visit in the Micro-ITT Population
At the EOT Visit the investigator indicated one of the following outcomes relating to the primary infection under study: Clinical Success: participant was alive; the ABSSSI sufficiently resolved such that further antibacterial therapy is not needed. Clinical Failure: any of the following: (1)Investigator discontinued study treatment and indicated that the ABSSSI had responded inadequately such that alternative (rescue) non-study antibacterial therapy was needed; (2)participant received antibacterial therapy for a different infection that may be effective for the ABSSSI under study; (3) participant developed an adverse event (AE) that required discontinuation of study treatment before completion of the planned treatment regimen; (4) unplanned major surgical treatment for the ABSSSI under study; (5) participant died of any cause up to the specified visit. Indeterminate: study data are unavailable for evaluation of efficacy for any reason (eg, missing data, lost to follow-up).
Time frame: After a minimum of 7 days up to 14 days of study treatment
Population: Micro-Intent-to-Treat (mITT) Population: all randomized participants in the mITT population with culture evidence of a baseline gram-positive ABSSSI pathogens (exclude sole gram negative and culture-negative participants)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| TNP-2092 | Investigator's Assessment of Clinical Response at the End of Treatment (EOT) Visit in the Micro-ITT Population | Success | 45 Participants |
| TNP-2092 | Investigator's Assessment of Clinical Response at the End of Treatment (EOT) Visit in the Micro-ITT Population | Failure | 2 Participants |
| TNP-2092 | Investigator's Assessment of Clinical Response at the End of Treatment (EOT) Visit in the Micro-ITT Population | Indeterminate | 4 Participants |
| Vancomycin | Investigator's Assessment of Clinical Response at the End of Treatment (EOT) Visit in the Micro-ITT Population | Success | 23 Participants |
| Vancomycin | Investigator's Assessment of Clinical Response at the End of Treatment (EOT) Visit in the Micro-ITT Population | Failure | 1 Participants |
| Vancomycin | Investigator's Assessment of Clinical Response at the End of Treatment (EOT) Visit in the Micro-ITT Population | Indeterminate | 5 Participants |
Secondary
Investigator's Assessment of Clinical Response at the End of Treatment (EOT) Visit in the mITT Population
At the EOT Visit the investigator indicated one of the following outcomes relating to the primary infection under study: Clinical Success: participant was alive; the ABSSSI sufficiently resolved such that further antibacterial therapy is not needed. Clinical Failure: any of the following: (1)Investigator discontinued study treatment and indicated that the ABSSSI had responded inadequately such that alternative (rescue) non-study antibacterial therapy was needed; (2)participant received antibacterial therapy for a different infection that may be effective for the ABSSSI under study; (3) participant developed an adverse event (AE) that required discontinuation of study treatment before completion of the planned treatment regimen; (4) unplanned major surgical treatment for the ABSSSI under study; (5) participant died of any cause up to the specified visit. Indeterminate: study data are unavailable for evaluation of efficacy for any reason (eg, missing data, lost to follow-up).
Time frame: After a minimum of 7 days up to 14 days of study treatment
Population: Modified Intent-to-Treat (mITT) Population: all randomized participants in the ITT population excluding those who have gram-negative pathogens only
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| TNP-2092 | Investigator's Assessment of Clinical Response at the End of Treatment (EOT) Visit in the mITT Population | Success | 68 Participants |
| TNP-2092 | Investigator's Assessment of Clinical Response at the End of Treatment (EOT) Visit in the mITT Population | Failure | 2 Participants |
| TNP-2092 | Investigator's Assessment of Clinical Response at the End of Treatment (EOT) Visit in the mITT Population | Indeterminate | 8 Participants |
| Vancomycin | Investigator's Assessment of Clinical Response at the End of Treatment (EOT) Visit in the mITT Population | Success | 31 Participants |
| Vancomycin | Investigator's Assessment of Clinical Response at the End of Treatment (EOT) Visit in the mITT Population | Failure | 3 Participants |
| Vancomycin | Investigator's Assessment of Clinical Response at the End of Treatment (EOT) Visit in the mITT Population | Indeterminate | 6 Participants |