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

Sponsor

TenNor Therapeutics Limited (Industry)

Overall Status

Completed

CT.gov ID

NCT03964493

Collaborator

(none)

118

Enrollment

Location

Arms

17.3

Actual Duration (Months)

6.8

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Skin and Subcutaneous Tissue Bacterial Infections Gram-Positive Bacterial Infections	Drug: TNP-2092 Drug: Vancomycin	Phase 2

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

118 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

TNP-2092 300 mg intravenous every 12 hours vancomycin 1 g intravenous every 12 hoursTNP-2092 300 mg intravenous every 12 hours vancomycin 1 g intravenous every 12 hours

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Apr 20, 2019

Actual Primary Completion Date :

Sep 28, 2020

Actual Study Completion Date :

Sep 28, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: TNP-2092 TNP-2092 300 mg intravenous every 12 hours	Drug: TNP-2092 TNP-2092 100mg/vial
Active Comparator: Vancomycin vancomycin 1 g intravenous every 12 hours	Drug: Vancomycin Vancomycin 1g/vial

Arm

Intervention/Treatment

Experimental: TNP-2092

TNP-2092 300 mg intravenous every 12 hours

Drug: TNP-2092

TNP-2092 100mg/vial

Active Comparator: Vancomycin

vancomycin 1 g intravenous every 12 hours

Drug: Vancomycin

Vancomycin 1g/vial

Outcome Measures

Primary Outcome Measures

Adverse Events as assessed by CTCAE v4.0 [Day 1 to Day 40]
Incidence, causality, and severity thrombotic events local infusion site reactions tolerability
Physical examination-Weight [Day 1 to Day 40]
Weight in kg
Physical examination-Hight [Day 1 to Day 40]
Hight in cm
Physical examination- others [Day 1 to Day 40]
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 [Day 1 to Day 40]
Oral Temperature in celsius
Vital signs- pulse rate [Day 1 to Day 40]
pulse rate
Vital signs- respiratory rate [Day 1 to Day 40]
respiratory rate
Vital signs - blood pressure [Day 1 to Day 40]
blood pressure in mmHg
Major serum chemistry findings - ALT [Day 1 to Day 40]
ALT in IU/L
Major serum chemistry findings - AST [Day 1 to Day 40]
AST in IU/L
Major serum chemistry findings - Billirubin [Day 1 to Day 40]
Billirubin in mg/dL
Major hematology findings - WBC [Day 1 to Day 40]
WBC in K/uL
Major hematology findings - RBC [Day 1 to Day 40]
RBC in K/uL
Major hematology findings - Platelet [Day 1 to Day 40]
Platelet in K/uL
Major coagulation findings - PT [Day 1 to Day 40]
PT (protime) in seconds
Major coagulation findings - PTT [Day 1 to Day 40]
PTT (partial thromboplastin time) in seconds
Major urinalysis findings -pH [Day 1 to Day 40]
pH value
Major urinalysis findings - Glucose [Day 1 to Day 40]
Glucose in mg/dL
Major urinalysis findings - Protein [Day 1 to Day 40]
Protein in mg/dL
Heptoglobin [Day 1 to Day 40]
Heptoglobin in mg/dL
ECG findings [Day 1 to Day 40]
Triplicate 12-lead ECG assessment

Secondary Outcome Measures

Primary PK parameters-Cmax [The first dose (Day 1) and the last dose (Day 3-14)]
Peak Plasma Concentration
Primary PK parameters-tmax [The first dose (Day 1) and the last dose (Day 3-14)]
Time to maximum plasma concentration
Primary PK parameters - AUC0-12 [The first dose (Day 1) and the last dose (Day 3-14)]
AUC versus time from time 0 to 12 hours
Programmatic clinical response [EA (48-72 hour) and EOT (Day 7-14)]
Percent reduction in primary ABSSSI lesion size
Microbiological response [EA (48-72 hour) and EOT (Day 7-14)]
Bacteria identification
Investigator's assessment [EA (48-72 hour) and EOT (Day 7-14)]
Improvement, Failure or Indeterminate

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.