MedTrace Logo

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

NCT02469857 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 290

Last updated 2021-10-05

Study results available
· View outcomes & findings →

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 (NSTI) receiving standard of care therapy.

Conditions

  • Necrotizing Soft Tissue Infections
  • Necrotizing Fasciitis
  • Fournier's Gangrene

Interventions

DRUG

AB103 0.5 mg/kg

OTHER

NaCl 0.9%

Sponsors & Collaborators

Principal Investigators

  • Wayne M Dankner, MD · Atox Bio Ltd

  • Eileen M Bulger, MD · Harborview Injury Prevention and Research Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-01
Primary Completion
2019-08-18
Completion
2019-10-18

Countries

  • United States
  • France

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02469857 on ClinicalTrials.gov