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TNP-2092 to Treat Acute Bacterial Skin and Skin Structure Infection | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

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

NCT03964493•TenNor Therapeutics Limited

View on ClinicalTrials.gov

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.

Detailed Description

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.

Locations (1)

eStudy Site

San Diego, California, United States

Key Dates

Start Date

April 20, 2019

Primary Completion Date

September 28, 2020

Completion Date

September 28, 2020

Last Updated

December 1, 2023

Enrollment

120

ACTUAL participants

Conditions

Skin and Subcutaneous Tissue Bacterial InfectionsGram-Positive Bacterial Infections

Interventions

TNP-2092

DRUG

Vancomycin

DRUG

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COMPLETED

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 1, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Drug Exposure and Minimum Inhibitory Concentration in the Treatment of MAC Lung Disease

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