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
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
Connect with a study center
eStudy Site
San Diego, California 92120
United StatesSite Not Available
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