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

NCT03964493 | Completed Phase 2 Results FDA Drug

• 1 other identifier: PJI001-02
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Skin and Subcutaneous Tissue Bacterial Infections; Gram-Positive Bacterial Infections

Keywords

TNP-2092; ABSSSI; Safety; Efficacy

Outcome Measures

Primary Outcomes (3)

• Early Clinical Response at the Early Assessment (EA) Visit in the Intent-to-Treat (ITT) Population

  Early clinical response is defined as responder meeting two criteria: (1) patient had at least a 20% reduction of acute bacterial skin and skin structure infection (ABSSSI) primary lesion size compared to baseline measurements; (2) patient did not die of any cause within 72 hours of the first dose of study treatment. An indeterminate classification is used for a response that could not be adequately inferred because study data are unavailable for evaluation of efficacy for any reason (eg, missing data, lost to follow-up, did not attend the EA clinic appointment), or if the early assessment visit is out of the 48 to 72 hours window after the intravenous study treatment starts.

  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

  Early clinical response is defined as responder meeting two criteria: (1) patient had at least a 20% reduction of acute bacterial skin and skin structure infection (ABSSSI) primary lesion size compared to baseline measurements; (2) patient did not die of any cause within 72 hours of the first dose of study treatment. An indeterminate classification is used for a response that could not be adequately inferred because study data are unavailable for evaluation of efficacy for any reason (eg, missing data, lost to follow-up, did not attend the EA clinic appointment), or if the early assessment visit is out of the 48 to 72 hours window after the intravenous study treatment starts.

  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

  Early clinical response is defined as responder meeting two criteria: (1) patient had at least a 20% reduction of acute bacterial skin and skin structure infection (ABSSSI) primary lesion size compared to baseline measurements; (2) patient did not die of any cause within 72 hours of the first dose of study treatment. An indeterminate classification is used for a response that could not be adequately inferred because study data are unavailable for evaluation of efficacy for any reason (eg, missing data, lost to follow-up, did not attend the EA clinic appointment), or if the early assessment visit is out of the 48 to 72 hours window after the intravenous study treatment starts.

  48 to 72 hours after the first dose of study treatment

Secondary Outcomes (8)

• Investigator Assessment of Clinical Response at Post Treatment Evaluation (PTE) Visit in the mITT Population

  7 to 14 days after the end of study treatment

• Investigator Assessment of Clinical Response at Post Treatment Evaluation (PTE) Visit in the Micro-ITT Population

  7 to 14 days after the end of study treatment

• Investigator's Assessment of Clinical Response at the End of Treatment (EOT) Visit in the mITT Population

  After a minimum of 7 days up to 14 days of study treatment

• Investigator's Assessment of Clinical Response at the End of Treatment (EOT) Visit in the Micro-ITT Population

  After a minimum of 7 days up to 14 days of study treatment

• AUC0-12h After First Infusion

  0 to 12 hours post-dose

Study Arms (2)

TNP-2092

EXPERIMENTAL

TNP-2092 300 mg intravenous every 12 hours

Drug: TNP-2092

Vancomycin

ACTIVE COMPARATOR

vancomycin 1 g intravenous every 12 hours

Drug: Vancomycin

Interventions

TNP-2092 DRUG

TNP-2092 100mg/vial

TNP-2092

Vancomycin DRUG

Vancomycin 1g/vial

Vancomycin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:

• 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.

Sponsors & Collaborators

• TenNor Therapeutics Limited: lead

Study Sites (1)

eStudy Site

San Diego, California, 92120, United States

Location

MeSH Terms

Conditions

Gram-Positive Bacterial Infections

Interventions

TNP-2092; Vancomycin

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Zhenkun Ma, PhD / CEO
• Organization: TenNor Therapeutics Limited

zhenkun.ma@tennorx.com

+1(646) 775-1861

Study Officials

• TenNor Clinical Trials

  TenNor

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: TNP-2092 300 mg intravenous every 12 hours vancomycin 1 g intravenous every 12 hours

Study Record Dates

• First Submitted: April 30, 2019
• First Posted: May 28, 2019
• Study Start: April 20, 2019
• Primary Completion: September 28, 2020
• Study Completion: September 28, 2020
• Last Updated: December 1, 2023
• Results First Posted: December 1, 2023

Record last verified: 2023-11

Locations

US (1)