TNP-2092 to Treat Acute Bacterial Skin and Skin Structure Infection
Completed · Phase 2
Conditions studied: Skin and Subcutaneous Tissue Bacterial Infections, Gram-Positive Bacterial Infections
In brief
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.
Key facts
- Study ID
- NCT03964493
- Run by
- TenNor Therapeutics Limited
- People needed
- 120
- Starts
- 2019-04-20
- Expected to finish
- 2020-09-28
- Last updated by the study team
- 2023-12-01
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- eStudy Site — San Diego, California, United States
Full record on ClinicalTrials.gov
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