Clinical Trial: Phase III Efficacy and Safety Study of AB103 in the Treatment of Patients With Necrotizing Soft Tissue Infections

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Phase III, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Study of AB103 as Compared to Placebo in Patients With Necrotizing Soft Tissue Infections. ACCUTE (AB103 Clinical Composite End

Brief Summary: The purpose of this study is to determine whether AB103 is safe and effective in the treatment of patients with necrotizing soft tissue infections receiving standard of care therapy.

Detailed Summary:

The primary hypothesis of this study is that in addition to standard of care treatment (which includes surgical intervention, antimicrobial therapy and critical care support for organ dysfunction or failure), AB103 will demonstrate a clinically significant treatment benefit over placebo.

This hypothesis will be addressed by measuring the effect of AB103 on a composite of clinical parameters associated with the disease course of patients with NSTI, using a responder analysis. A responding patient must meet all 5 parameters of the composite clinical success end point, while a non-responding patient can fail by not meeting any one of the parameters. These analyses are designed to demonstrate that in addition to being safe, one dose of 0.5 mg/kg of AB103 will:

Improve systemic signs of the infection by improving organ function of patients compared to placebo as measured by:

  • Survival at Day 28
  • Modified SOFA (mSOFA) score on Day 14 and change from baseline to Day 14 ≥ 3. A Day 14 mSOFA score of ≤1 and a change from baseline (pre-treatment) to Day 14 ≥3 will be required for a patient to achieve the primary composite clinical success endpoint (NICCE)

Improve the local signs of the infection, as measured by:

  • Reduced number of debridements, counted to Day 14. No more than 3 debridements to Day 14 will be required for a patient to achieve composite clinical success

  • No amputation after the first debridement (amputation on the first debridement is not considered a failure). A patient wi
    Sponsor: Atox Bio Ltd

    Current Primary Outcome:

    • NICCE: Clinical composite success end point [ Time Frame: 28 days ]
      Success is defined as meeting all 5 components of the composite score: Alive until Day 28, (ii) Day 14 debridements ≤3 (iii) No amputation done after the first debridement (iv) Day 14 mSOFA score ≤1 (v) Reduction of ≥3 score points between Baseline and Day 14 mSOFA score
    • Modified clinical composite endpoint: [ Time Frame: 28 days ]
      Success is defined as meeting all 3 components of the composite score: Alive until Day 28, (ii) Day 14 debridements ≤3 (iii) No amputation done after the first debridement


    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    • Safety measures Adverse Events [ Time Frame: 28 days ]
      Measures throughout Day 28: Adverse Events (includes Serious Adverse Events (SAEs).
    • Safety measures Clinical safety laboratory [ Time Frame: 28 days ]
      Measures throughout Day 14: Clinical safety laboratory
    • Safety measures Secondary infections [ Time Frame: 28 days ]
      Measures throughout Day 28: Secondary infections
    • Recovery from acute kidney injury [ Time Frame: 28 days ]
    • Time to resolution of mSOFA score to ≤ 1 [ Time Frame: 14 days ]
    • Critical care and hospital stay parameters ICU days [ Time Frame: 28 days ]
      ICU days
    • Critical care and hospital stay parameters Ventilator days [ Time Frame: 28 days ]
      Ventilator days
    • Critical care and hospital stay parameters Hospital length of stay [ Time Frame: 28 days ]
      Hospital length of stay


    Original Secondary Outcome: Same as current

    Information By: Atox Bio Ltd

    Dates:
    Date Received: June 6, 2015
    Date Started: September 2015
    Date Completion: March 2019
    Last Updated: May 1, 2017
    Last Verified: May 2017