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

• Status: Completed
• Trial end date: 2020-09-28
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: TenNor Therapeutics Limited
• Treatments: Vancomycin

Criteria

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.