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

NCT ID: NCT03964493

Last Updated: 2023-12-01

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-20

Study Completion Date

2020-09-28

Brief Summary

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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.

Detailed Description

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This Phase 2, double-blind, randomized, multicenter, parallel, controlled study is conducted to evaluate safety, tolerability, pharmacokinetics and efficacy of TNP-2092, and vancomycin in adults with ABSSSI suspected or confirmed to be caused by gram-positive pathogens. The duration of the treatment period is a minimum of 7 days and a maximum of 14 days.

Conditions

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Skin and Subcutaneous Tissue Bacterial Infections Gram-Positive Bacterial Infections

Keywords

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TNP-2092 ABSSSI Safety Efficacy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

TNP-2092 300 mg intravenous every 12 hours vancomycin 1 g intravenous every 12 hours
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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TNP-2092

TNP-2092 300 mg intravenous every 12 hours

Group Type EXPERIMENTAL

TNP-2092

Intervention Type DRUG

TNP-2092 100mg/vial

Vancomycin

vancomycin 1 g intravenous every 12 hours

Group Type ACTIVE_COMPARATOR

Vancomycin

Intervention Type DRUG

Vancomycin 1g/vial

Interventions

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TNP-2092

TNP-2092 100mg/vial

Intervention Type DRUG

Vancomycin

Vancomycin 1g/vial

Intervention Type DRUG

Eligibility Criteria

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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

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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TenNor Therapeutics Limited

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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TenNor Clinical Trials

Role: STUDY_DIRECTOR

TenNor

Locations

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eStudy Site

San Diego, California, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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PJI001-02

Identifier Type: -

Identifier Source: org_study_id