At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 290 enrolled
Drug / intervention
AB103 0.5 mg/kg +1 moredrug
Likely dose
AB103 0.5 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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 Endpoint Study in Necrotizing Soft Tissue Infections)
In Brief
A Phase 3 clinical trial evaluating AB103 0.5 mg/kg and NaCl 0.9% for Necrotizing Soft Tissue Infections and 2 related conditions. Completed, enrolled 290 participants across 71 sites in 2 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesFrance, United States
Timeline
Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedJun 2015
Enrollment StartDec 2015
Primary CompletionAug 2019
Study CompletionOct 2019
TodayJul 2026
First PostedJun 12, 2015
Enrollment StartDec 1, 2015
Primary CompletionAug 18, 2019
Study CompletionOct 18, 2019
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 11.1 years ago
Interventions
AB103 0.5 mg/kgdrug
NaCl 0.9%other