TNP-2092 to Treat Acute Bacterial Skin and Skin Structure Infection
- Conditions
- Skin and Subcutaneous Tissue Bacterial InfectionsGram-Positive Bacterial Infections
- Interventions
- Registration Number
- NCT03964493
- Lead Sponsor
- TenNor Therapeutics Limited
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
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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.
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Subjects will be excluded from the study if any of the following exclusion criteria apply prior to randomization:
- History or hypersensitivity or intolerability to any fluoroquinolone, rifamycin or glycopeptide classes;
- ABSSSI suspected or confirmed to be caused by pathogens that are resistant to the glycopeptide class;
- Prior administration of systemic antibacterial therapy within 96 hours before randomization;
- ABSSSI with suspected or confirmed infection caused by gram-negative or anaerobic organisms;
- ABSSSI with suspected or confirmed infection caused by fungal, mycobacterial, parasitic, or viral pathogens;
- Evidence of significant hepatic, hematologic, or immunologic disease;
- History or evidence of severe renal disease.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Vancomycin Vancomycin vancomycin 1 g intravenous every 12 hours TNP-2092 TNP-2092 TNP-2092 300 mg intravenous every 12 hours
- Primary Outcome Measures
Name Time Method 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.
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.
- Secondary Outcome Measures
Name Time Method 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
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).
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).
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).
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.
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'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).
Trial Locations
- Locations (1)
eStudy Site
🇺🇸San Diego, California, United States