Overview

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.