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TNP-2092 to Treat Acute Bacterial Skin and Skin Structure Infection (P2_ABSSSI)

Primary Purpose

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

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
TNP-2092
Vancomycin
Sponsored by
TenNor Therapeutics Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Skin and Subcutaneous Tissue Bacterial Infections focused on measuring TNP-2092, ABSSSI, Safety, PK, Efficacy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • eStudy Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

TNP-2092

Vancomycin

Arm Description

TNP-2092 300 mg intravenous every 12 hours

vancomycin 1 g intravenous every 12 hours

Outcomes

Primary Outcome Measures

Adverse Events as assessed by CTCAE v4.0
Incidence, causality, and severity thrombotic events local infusion site reactions tolerability
Physical examination-Weight
Weight in kg
Physical examination-Hight
Hight in cm
Physical examination- others
head, ears, eyes, nose, throat dentition, thyroid, chest(heart, lungs),abdomen, skin/soft tissues, neurological, extremities, back, neck, musculoskeletal, and lymph nodes
Vital signs-Temperature
Oral Temperature in celsius
Vital signs- pulse rate
pulse rate
Vital signs- respiratory rate
respiratory rate
Vital signs - blood pressure
blood pressure in mmHg
Major serum chemistry findings - ALT
ALT in IU/L
Major serum chemistry findings - AST
AST in IU/L
Major serum chemistry findings - Billirubin
Billirubin in mg/dL
Major hematology findings - WBC
WBC in K/uL
Major hematology findings - RBC
RBC in K/uL
Major hematology findings - Platelet
Platelet in K/uL
Major coagulation findings - PT
PT (protime) in seconds
Major coagulation findings - PTT
PTT (partial thromboplastin time) in seconds
Major urinalysis findings -pH
pH value
Major urinalysis findings - Glucose
Glucose in mg/dL
Major urinalysis findings - Protein
Protein in mg/dL
Heptoglobin
Heptoglobin in mg/dL
ECG findings
Triplicate 12-lead ECG assessment

Secondary Outcome Measures

Primary PK parameters-Cmax
Peak Plasma Concentration
Primary PK parameters-tmax
Time to maximum plasma concentration
Primary PK parameters - AUC0-12
AUC versus time from time 0 to 12 hours
Programmatic clinical response
Percent reduction in primary ABSSSI lesion size
Microbiological response
Bacteria identification
Investigator's assessment
Improvement, Failure or Indeterminate

Full Information

First Posted
April 30, 2019
Last Updated
October 10, 2020
Sponsor
TenNor Therapeutics Limited
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1. Study Identification

Unique Protocol Identification Number
NCT03964493
Brief Title
TNP-2092 to Treat Acute Bacterial Skin and Skin Structure Infection
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
April 20, 2019 (Actual)
Primary Completion Date
September 28, 2020 (Actual)
Study Completion Date
September 28, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
TenNor Therapeutics Limited

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin and Subcutaneous Tissue Bacterial Infections, Gram-Positive Bacterial Infections
Keywords
TNP-2092, ABSSSI, Safety, PK, Efficacy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
TNP-2092 300 mg intravenous every 12 hours vancomycin 1 g intravenous every 12 hours
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
118 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TNP-2092
Arm Type
Experimental
Arm Description
TNP-2092 300 mg intravenous every 12 hours
Arm Title
Vancomycin
Arm Type
Active Comparator
Arm Description
vancomycin 1 g intravenous every 12 hours
Intervention Type
Drug
Intervention Name(s)
TNP-2092
Intervention Description
TNP-2092 100mg/vial
Intervention Type
Drug
Intervention Name(s)
Vancomycin
Intervention Description
Vancomycin 1g/vial
Primary Outcome Measure Information:
Title
Adverse Events as assessed by CTCAE v4.0
Description
Incidence, causality, and severity thrombotic events local infusion site reactions tolerability
Time Frame
Day 1 to Day 40
Title
Physical examination-Weight
Description
Weight in kg
Time Frame
Day 1 to Day 40
Title
Physical examination-Hight
Description
Hight in cm
Time Frame
Day 1 to Day 40
Title
Physical examination- others
Description
head, ears, eyes, nose, throat dentition, thyroid, chest(heart, lungs),abdomen, skin/soft tissues, neurological, extremities, back, neck, musculoskeletal, and lymph nodes
Time Frame
Day 1 to Day 40
Title
Vital signs-Temperature
Description
Oral Temperature in celsius
Time Frame
Day 1 to Day 40
Title
Vital signs- pulse rate
Description
pulse rate
Time Frame
Day 1 to Day 40
Title
Vital signs- respiratory rate
Description
respiratory rate
Time Frame
Day 1 to Day 40
Title
Vital signs - blood pressure
Description
blood pressure in mmHg
Time Frame
Day 1 to Day 40
Title
Major serum chemistry findings - ALT
Description
ALT in IU/L
Time Frame
Day 1 to Day 40
Title
Major serum chemistry findings - AST
Description
AST in IU/L
Time Frame
Day 1 to Day 40
Title
Major serum chemistry findings - Billirubin
Description
Billirubin in mg/dL
Time Frame
Day 1 to Day 40
Title
Major hematology findings - WBC
Description
WBC in K/uL
Time Frame
Day 1 to Day 40
Title
Major hematology findings - RBC
Description
RBC in K/uL
Time Frame
Day 1 to Day 40
Title
Major hematology findings - Platelet
Description
Platelet in K/uL
Time Frame
Day 1 to Day 40
Title
Major coagulation findings - PT
Description
PT (protime) in seconds
Time Frame
Day 1 to Day 40
Title
Major coagulation findings - PTT
Description
PTT (partial thromboplastin time) in seconds
Time Frame
Day 1 to Day 40
Title
Major urinalysis findings -pH
Description
pH value
Time Frame
Day 1 to Day 40
Title
Major urinalysis findings - Glucose
Description
Glucose in mg/dL
Time Frame
Day 1 to Day 40
Title
Major urinalysis findings - Protein
Description
Protein in mg/dL
Time Frame
Day 1 to Day 40
Title
Heptoglobin
Description
Heptoglobin in mg/dL
Time Frame
Day 1 to Day 40
Title
ECG findings
Description
Triplicate 12-lead ECG assessment
Time Frame
Day 1 to Day 40
Secondary Outcome Measure Information:
Title
Primary PK parameters-Cmax
Description
Peak Plasma Concentration
Time Frame
The first dose (Day 1) and the last dose (Day 3-14)
Title
Primary PK parameters-tmax
Description
Time to maximum plasma concentration
Time Frame
The first dose (Day 1) and the last dose (Day 3-14)
Title
Primary PK parameters - AUC0-12
Description
AUC versus time from time 0 to 12 hours
Time Frame
The first dose (Day 1) and the last dose (Day 3-14)
Title
Programmatic clinical response
Description
Percent reduction in primary ABSSSI lesion size
Time Frame
EA (48-72 hour) and EOT (Day 7-14)
Title
Microbiological response
Description
Bacteria identification
Time Frame
EA (48-72 hour) and EOT (Day 7-14)
Title
Investigator's assessment
Description
Improvement, Failure or Indeterminate
Time Frame
EA (48-72 hour) and EOT (Day 7-14)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
eStudy Site
City
San Diego
State/Province
California
ZIP/Postal Code
92120
Country
United States

12. IPD Sharing Statement

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

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