Clinical trial NCT03964493: TNP-2092 to Treat Acute Bacterial Skin and Skin Structure Infection
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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Skin and Subcutaneous Tissue Bacterial Infections
Gram-Positive Bacterial Infections
Keywords: TNP-2092
ABSSSI
Safety
Efficacy
Lead sponsor: TenNor Therapeutics Inc.
Sponsor class: INDUSTRY
First posted: 2019-05-28
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: TNP-2092 300 mg intravenous every 12 hours vancomycin 1 g intravenous every 12 hours
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Early Clinical Response at the Early Assessment (EA) Visit in the Intent-to-Treat (ITT) Population
timeFrame: 48 to 72 hours after the first dose of study treatment
measure: Early Clinical Response at the Early Assessment Visit in the Modified Intent-to-Treat (mITT) Population
timeFrame: 48 to 72 hours after the first dose of study treatment
measure: Early Clinical Response at the Early Assessment Visit in the Micro-Intent-to-Treat (Micro-ITT) Population
timeFrame: 48 to 72 hours after the first dose of study treatment
Secondary outcomes:
measure: Investigator Assessment of Clinical Response at Post Treatment Evaluation (PTE) Visit in the mITT Population
timeFrame: 7 to 14 days after the end of study treatment
measure: Investigator Assessment of Clinical Response at Post Treatment Evaluation (PTE) Visit in the Micro-ITT Population
timeFrame: 7 to 14 days after the end of study treatment
measure: Investigator's Assessment of Clinical Response at the End of Treatment (EOT) Visit in the mITT Population
timeFrame: After a minimum of 7 days up to 14 days of study treatment
measure: Investigator's Assessment of Clinical Response at the End of Treatment (EOT) Visit in the Micro-ITT Population
timeFrame: After a minimum of 7 days up to 14 days of study treatment
measure: AUC0-12h After First Infusion
timeFrame: 0 to 12 hours post-dose
measure: AUC0-12h After Last Infusion
timeFrame: 0 to 12 hours post-dose
measure: Cmax After Last Infusion
timeFrame: 57 to 60 minutes, 1.5 to 3 hours, 4 to 6 hours, 12 hours, after the last infusion
measure: Cmax After First Infusion
timeFrame: 57 to 60 minutes, 1.5 to 3 hours, 4 to 6 hours, 12 hours, after the first infusion
Other outcomes:
Locations:
city: San Diego
country: United States
facility: eStudy Site
state: California
Study officials:
affiliation: TenNor
name: TenNor Clinical Trials
role: STUDY_DIRECTOR
References: