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

Last updated: November 8, 2023
Sponsor: TenNor Therapeutics Limited
Overall Status: Completed

Phase

2

Condition

Bacterial Infections

Treatment

TNP-2092

Vancomycin

Clinical Study ID

NCT03964493
PJI001-02
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Subjects may be included in the study if they meet all of the following inclusioncriteria:
  • 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

Exclusion Criteria:

  • Subjects will be excluded from the study if any of the following exclusion criteriaapply prior to randomization:
  • History or hypersensitivity or intolerability to any fluoroquinolone, rifamycinor glycopeptide classes;
  • ABSSSI suspected or confirmed to be caused by pathogens that are resistant to theglycopeptide class;
  • Prior administration of systemic antibacterial therapy within 96 hours beforerandomization;
  • ABSSSI with suspected or confirmed infection caused by gram-negative or anaerobicorganisms;
  • 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

Total Participants: 120
Treatment Group(s): 2
Primary Treatment: TNP-2092
Phase: 2
Study Start date:
April 20, 2019
Estimated Completion Date:
September 28, 2020

Study 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.

Connect with a study center

  • eStudy Site

    San Diego, California 92120
    United States

    Site Not Available

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