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

Gram-Positive Bacterial Infections Clinical Trial

— P2_ABSSSI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03964493
• Other study ID #: PJI001-02
• Status: Completed
• Phase: Phase 2
• Start date: April 20, 2019
• Est. completion date: September 28, 2020

Study information

• Verified date: November 2023
• Source: TenNor Therapeutics Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: September 28, 2020
• Est. primary completion date: September 28, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bacterial Infections
• Communicable Diseases
• Gram-Positive Bacterial Infections
• Infections
• Skin and Subcutaneous Tissue Bacterial Infections

Intervention

Drug:
• TNP-2092
TNP-2092 100mg/vial
• Vancomycin
Vancomycin 1g/vial

Locations

Country	Name	City	State
United States	eStudy Site	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
TenNor Therapeutics Limited

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Investigator Assessment of Clinical Response at Post Treatment Evaluation (PTE) Visit in the mITT Population	At the PTE Visit the investigator indicated one of the following outcomes relating to the primary infection under study: Clinical Success: participant was alive; the ABSSSI sufficiently resolved such that further antibacterial therapy is not needed. Clinical Failure: any of the following: (1)Investigator discontinued study treatment and indicated that the ABSSSI had responded inadequately such that alternative (rescue) non-study antibacterial therapy was needed; (2)participant received antibacterial therapy for a different infection that may be effective for the ABSSSI under study; (3) participant developed an adverse event (AE) that required discontinuation of study treatment before completion of the planned treatment regimen; (4) unplanned major surgical treatment for the ABSSSI under study; (5) participant died of any cause up to the specified visit. Indeterminate: study data are unavailable for evaluation of efficacy for any reason (eg, missing data, lost to follow-up).	7 to 14 days after the end of study treatment
Secondary	Investigator Assessment of Clinical Response at Post Treatment Evaluation (PTE) Visit in the Micro-ITT Population	At the PTE Visit the investigator indicated one of the following outcomes relating to the primary infection under study: Clinical Success: participant was alive; the ABSSSI sufficiently resolved such that further antibacterial therapy is not needed. Clinical Failure: any of the following: (1)Investigator discontinued study treatment and indicated that the ABSSSI had responded inadequately such that alternative (rescue) non-study antibacterial therapy was needed; (2)participant received antibacterial therapy for a different infection that may be effective for the ABSSSI under study; (3) participant developed an adverse event (AE) that required discontinuation of study treatment before completion of the planned treatment regimen; (4) unplanned major surgical treatment for the ABSSSI under study; (5) participant died of any cause up to the specified visit. Indeterminate: study data are unavailable for evaluation of efficacy for any reason (eg, missing data, lost to follow-up).	7 to 14 days after the end of study treatment
Secondary	Investigator's Assessment of Clinical Response at the End of Treatment (EOT) Visit in the mITT Population	At the EOT Visit the investigator indicated one of the following outcomes relating to the primary infection under study: Clinical Success: participant was alive; the ABSSSI sufficiently resolved such that further antibacterial therapy is not needed. Clinical Failure: any of the following: (1)Investigator discontinued study treatment and indicated that the ABSSSI had responded inadequately such that alternative (rescue) non-study antibacterial therapy was needed; (2)participant received antibacterial therapy for a different infection that may be effective for the ABSSSI under study; (3) participant developed an adverse event (AE) that required discontinuation of study treatment before completion of the planned treatment regimen; (4) unplanned major surgical treatment for the ABSSSI under study; (5) participant died of any cause up to the specified visit. Indeterminate: study data are unavailable for evaluation of efficacy for any reason (eg, missing data, lost to follow-up).	After a minimum of 7 days up to 14 days of study treatment
Secondary	Investigator's Assessment of Clinical Response at the End of Treatment (EOT) Visit in the Micro-ITT Population	At the EOT Visit the investigator indicated one of the following outcomes relating to the primary infection under study: Clinical Success: participant was alive; the ABSSSI sufficiently resolved such that further antibacterial therapy is not needed. Clinical Failure: any of the following: (1)Investigator discontinued study treatment and indicated that the ABSSSI had responded inadequately such that alternative (rescue) non-study antibacterial therapy was needed; (2)participant received antibacterial therapy for a different infection that may be effective for the ABSSSI under study; (3) participant developed an adverse event (AE) that required discontinuation of study treatment before completion of the planned treatment regimen; (4) unplanned major surgical treatment for the ABSSSI under study; (5) participant died of any cause up to the specified visit. Indeterminate: study data are unavailable for evaluation of efficacy for any reason (eg, missing data, lost to follow-up).	After a minimum of 7 days up to 14 days of study treatment
Secondary	AUC0-12h After First Infusion	Partial area under the concentration versus time curve from time zero to time 12 hours.	0 to 12 hours post-dose
Secondary	AUC0-12h After Last Infusion	Partial area under the concentration versus time curve from time zero to time 12 hours	0 to 12 hours post-dose
Secondary	Cmax After Last Infusion	Maximum observed concentration	57 to 60 minutes, 1.5 to 3 hours, 4 to 6 hours, 12 hours, after the last infusion
Secondary	Cmax After First Infusion	Maximum observed concentration	57 to 60 minutes, 1.5 to 3 hours, 4 to 6 hours, 12 hours, after the first infusion