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Completed

NCT Number: NCT03964493

TNP-2092 to Treat Acute Bacterial Skin and Skin Structure Infection

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.

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Key information

Conditions

Skin and Subcutaneous Tissue Bacterial Infections Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

eStudy Site

San Diego, California, 92120, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 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.

Treatment and study plan

TNP-2092

Drug

TNP-2092 100mg/vial

Vancomycin

Drug

Vancomycin 1g/vial

Primary outcomes

  1. Early Clinical Response at the Early Assessment (EA) Visit in the Intent-to-Treat (ITT) Population

    Time frame: 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.

  2. Early Clinical Response at the Early Assessment Visit in the Modified Intent-to-Treat (mITT) Population

    Time frame: 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.

  3. Early Clinical Response at the Early Assessment Visit in the Micro-Intent-to-Treat (Micro-ITT) Population

    Time frame: 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 outcomes

  1. Investigator Assessment of Clinical Response at Post Treatment Evaluation (PTE) Visit in the mITT Population

    Time frame: 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).

  2. Investigator Assessment of Clinical Response at Post Treatment Evaluation (PTE) Visit in the Micro-ITT Population

    Time frame: 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).

  3. Investigator's Assessment of Clinical Response at the End of Treatment (EOT) Visit in the mITT Population

    Time frame: 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).

  4. Investigator's Assessment of Clinical Response at the End of Treatment (EOT) Visit in the Micro-ITT Population

    Time frame: 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).

  5. AUC0-12h After First Infusion

    Time frame: 0 to 12 hours post-dose

    Partial area under the concentration versus time curve from time zero to time 12 hours.

  6. AUC0-12h After Last Infusion

    Time frame: 0 to 12 hours post-dose

    Partial area under the concentration versus time curve from time zero to time 12 hours

  7. Cmax After Last Infusion

    Time frame: 57 to 60 minutes, 1.5 to 3 hours, 4 to 6 hours, 12 hours, after the last infusion

    Maximum observed concentration

  8. Cmax After First Infusion

    Time frame: 57 to 60 minutes, 1.5 to 3 hours, 4 to 6 hours, 12 hours, after the first infusion

    Maximum observed concentration

Sponsors and collaborators

Lead sponsor

TenNor Therapeutics Limited

Industry

Registry information

Official study title

Phase 2, Double-Blind, Randomized, Multicenter, Parallel, Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of TNP-2092 to Treat Acute Bacterial Skin and Skin Structure Infection in Adults

Acronym: P2_ABSSSI

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
May 28, 2019
Registry last updated
Dec 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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