TNP-2092 to Treat Acute Bacterial Skin and Skin Structure Infection (P2_ABSSSI)

TenNor Therapeutics

Status and phase: Completed; Phase 2

Conditions: Skin and Subcutaneous Tissue Bacterial Infections; Gram-Positive Bacterial Infections

Treatments: Drug: TNP-2092; Drug: Vancomycin

Study type: Interventional

Funder types: Industry

Identifiers

NCT03964493

PJI001-02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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120 participants in 2 patient groups

TNP-2092

Experimental group

Description:

TNP-2092 300 mg intravenous every 12 hours

Treatment:

Drug: TNP-2092

Vancomycin

Active Comparator group

Description:

vancomycin 1 g intravenous every 12 hours

Treatment:

Drug: Vancomycin