Clinical trial
Phase 2, Double-Blind, Randomized, Multicenter, Parallel, Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of TNP-2092 to Treat Acute Bacterial Skin and Skin Structure Infection in Adults
Name
PJI001-02
Description
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.
Trial arms
Trial start
2019-04-20
Estimated PCD
2020-09-28
Trial end
2020-09-28
Status
Completed
Phase
Early phase I
Treatment
TNP-2092
TNP-2092 100mg/vial
Arms:
TNP-2092
Vancomycin
Vancomycin 1g/vial
Arms:
Vancomycin
Size
120
Primary endpoint
Early Clinical Response at the Early Assessment (EA) Visit in the Intent-to-Treat (ITT) Population
48 to 72 hours after the first dose of study treatment
Early Clinical Response at the Early Assessment Visit in the Modified Intent-to-Treat (mITT) Population
48 to 72 hours after the first dose of study treatment
Early Clinical Response at the Early Assessment Visit in the Micro-Intent-to-Treat (Micro-ITT) Population
48 to 72 hours after the first dose of study treatment
Eligibility 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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'TNP-2092 300 mg intravenous every 12 hours vancomycin 1 g intravenous every 12 hours', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 120, 'type': 'ACTUAL'}}
Updated at
2023-12-01
1 organization
2 products
2 indications
Organization
TenNor TherapeuticsProduct
TNP-2092Indication
Gram-Positive Bacterial InfectionsProduct
Vancomycin