Phase III Efficacy and Safety Study of AB103 in the Treatment of Patients With Necrotizing Soft Tissue Infections
ACCUTE
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)
1 other identifier
interventional
290
2 countries
71
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 (NSTI) receiving standard of care therapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Dec 2015
Typical duration for phase_3
71 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 6, 2015
CompletedFirst Posted
Study publicly available on registry
June 12, 2015
CompletedStudy Start
First participant enrolled
December 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 18, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 18, 2019
CompletedResults Posted
Study results publicly available
October 5, 2021
CompletedOctober 5, 2021
October 1, 2021
3.7 years
June 6, 2015
September 3, 2021
October 2, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Patients Achieving Necrotizing Infections Clinical Composite Endpoint (NICCE)
NICCE was made up of the following 5 components, all of which had to be met to successfully achieve the primary outcome measure (i.e., a "responder"): (i) Alive at Day 28, (ii) ≤ 3 debridements through Day 14, (iii) No amputation performed after the first debridement, (iv) Day 14 modified Sequential Organ Failure Assessment (mSOFA) score ≤ 1, and (v) Reduction of ≥ 3 mSOFA score points between Baseline and Day 14. This analysis compared responders in the reltecimod group versus responders in the placebo group. Modified Sequential Organ Failure Assessment (mSOFA) total scores range from 0 to 20, with higher scores reflecting a worse clinical status or outcome. An mSOFA total score of 0 or 1 reflects resolution of organ dysfunction/failure.
28 days
Secondary Outcomes (9)
Number of Patients With One or More Adverse Events (AEs)
28 days
Number of Patients With One or More Serious Adverse Events (SAEs)
28 days
Number of Patients With One or More Secondary Infections
28 days
Number of Patients Achieving Day 14 Modified Sequential Organ Failure Assessment (mSOFA) Score of 0 or 1
14 days
Intensive Care Unit (ICU)-Free Days
28 days
- +4 more secondary outcomes
Other Outcomes (10)
Number of Deaths From Day 0 Through Day 90
90 days
Number of Deaths After Day 14 Through Day 90
76 days (after Day 14 through Day 90)
Number of Deaths From Day 0 Through Day 90 Among Patients With a Screening mSOFA Score of at Least 5
90 days
- +7 more other outcomes
Study Arms (2)
AB103 0.5 mg/kg
EXPERIMENTALAB103 0.5 mg/kg, IV, single dose
NaCl 0.9%
PLACEBO COMPARATORNaCl 0.9%, IV, single dose
Interventions
Eligibility Criteria
You may qualify if:
- Surgical confirmation of NSTI by attending surgeon;
- mSOFA score ≥3 (in any one or combination of the 5 major components of SOFA score with one organ component having a score of at least 2: cardiovascular, respiratory, renal, coagulation, CNS), measured as close as possible to the first debridement;
- IV drug administration within 6 hours from the clinical diagnosis and the decision at the study site, to have an urgent surgical exploration and debridement (drug should not be administered until surgical confirmation is established);
- If a woman is of childbearing potential, she must consistently use an acceptable method of contraception from baseline through Day 28;
- If a male patient's sexual partner is of childbearing potential, the male patient must acknowledge that they will consistently use an acceptable method of contraception (defined above) from baseline through Day 28.
- Signed and dated informed consent (ICF) as defined by the Institutional Review Board (IRB) and, if applicable, California Bill of Rights. If patient is unable to comprehend or sign the ICF, patient's legally acceptable representative may sign the ICF
You may not qualify if:
- BMI\>51;
- Patient who has been operated at least once for the current NSTI infection and had a curative deep tissue debridement;
- Patients with overt peripheral vascular disease in the involved area ;
- Diabetic patients with peripheral vascular disease who present with below the ankle infection;
- Patient with burn wounds;
- Current condition of: (a) Inability to maintain a mean arterial pressure \> 50 mmHg and/or systolic blood pressure \> 70 mmHg for at least 1 hour prior to screening despite the presence of vasopressors and IV fluids or (b) a patient with respiratory failure such that an SaO2 of 80% cannot be achieved or (c) a patient with refractory coagulopathy (INR \>5) or thrombocytopenia (platelet count \<20,000) that does not partially correct with administration of appropriate factors or blood products;
- Chronic neurological impairment that leads to a neuro mSOFA component ≥2;
- Recent cerebrovascular accident in the last 3 months;
- Patients with cardiac arrest requiring cardiopulmonary resuscitation within the past 30 days;
- Patient is not expected to survive throughout 28 days of study due to underlying medical condition, such as poorly controlled neoplasm;
- Patient or patient's family are not committed to aggressive management of the patient's condition;
- Any concurrent medical condition, which in the opinion of the Investigator, may compromise the safety of the patient or the objectives of the study or the patient will not benefit from treatment such as:
- Congestive heart failure (CHF){ New York Heart Association (NYHA) class III-IV}
- Severe chronic pulmonary obstructive disease (COPD)
- Liver dysfunction {Childs-Pugh class C}
- +11 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (71)
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
Maricopa Medical Center
Phoenix, Arizona, 85008, United States
Banner University Medical Center
Tucson, Arizona, 24857, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205, United States
Loma Linda University Medical Center
Loma Linda, California, 92354, United States
Los Angeles Biomedical Research Institute at Harbor UCLA Medical Center
Los Angeles, California, 90502, United States
University of California, Davis Medical Center
Sacramento, California, 95817, United States
UCSD Medical Center
San Diego, California, 92103, United States
UCH-Memorial Health System
Colorado Springs, Colorado, 80909, United States
University of Colorado Hospital
Denver, Colorado, 80045, United States
Yale New Haven Hospital
New Haven, Connecticut, 06520, United States
Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
UF Health Shands Hospital
Gainesville, Florida, 32610, United States
Ryder Trauma Center/Jackson Memorial Hospital
Miami, Florida, 33136, United States
Emory University at Grady Memorial Hospital
Atlanta, Georgia, 30303, United States
Augusta University Health
Augusta, Georgia, 30912, United States
University of Iowa Hospital and Clinics
Iowa City, Iowa, 52242, United States
University of Kentucky
Lexington, Kentucky, 40536, United States
Our Lady of the Lake Regional Medical Center
Baton Rouge, Louisiana, 70808, United States
Baton Rouge General Hospital
Baton Rouge, Louisiana, 70809, United States
LSU Health Science Center
New Orleans, Louisiana, 70112, United States
Maine Medical Center
Portland, Maine, 04102, United States
University of Maryland R Adams Cowley Shock Trauma Center
Baltimore, Maryland, 21201, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Wayne State University-Detroit Receiving Hospital
Detroit, Michigan, 48201, United States
Henry Ford Health System
Detroit, Michigan, 48202, United States
Wayne State University-Sinai Grace Hospital
Detroit, Michigan, 48235, United States
Fairview Southdale Hospital
Edina, Minnesota, 55435, United States
Hennepin County Medical Center
Minneapolis, Minnesota, 55415, United States
University of Minnesota Medical Center-Fairview
Minneapolis, Minnesota, 55455, United States
University of Missouri
Columbia, Missouri, 65211, United States
St Louis University
St Louis, Missouri, 63103, United States
Cooper University Hospital
Camden, New Jersey, 08103, United States
Capital Health System, Inc.
Trenton, New Jersey, 98638, United States
Albany Medical Center
Albany, New York, 12208, United States
Erie County Medical Center-Affliate of SUNYat Buffalo
Buffalo, New York, 14215, United States
Staten Island University Hospital-Northwell Health
Staten Island, New York, 10305, United States
Carolinas Medical Center
Charlotte, North Carolina, 28208, United States
East Carolina University
Greenville, North Carolina, 27834, United States
University of Cincinnati Medical Center (UCMC)
Cincinnati, Ohio, 45219, United States
The MetroHealth System
Cleveland, Ohio, 44109, United States
The Ohio State University
Columbus, Ohio, 43210, United States
Wright State University & Premier Health Clinical Trials Research Alliance
Dayton, Ohio, 45409, United States
St Elizabeth Youngstown Hospital
Youngstown, Ohio, 44501, United States
Legacy Emanuel Hospital
Portland, Oregon, 97227, United States
Oregon Health and Science University
Portland, Oregon, 97239, United States
St. Luke's University Health Network
Bethlehem, Pennsylvania, 18015, United States
The Pennsylvania State University and The Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
The Trauma Center at PENN
Philadelphia, Pennsylvania, 19104, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
Texas Tech University Health Sciences Center at El Paso
El Paso, Texas, 79905, United States
John Peter Smith Health Network
Fort Worth, Texas, 76104, United States
Baylor College of Medicine-Ben Taub Hospital
Houston, Texas, 77030, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229, United States
Scott and White Medical Center
Temple, Texas, 76502, United States
Harborview Medical Center
Seattle, Washington, 98104, United States
Medical College of Wisconsin-Froedtert Hospital
Milwaukee, Wisconsin, 53226, United States
Hộpital Estaing-CHU de Clermont-Ferrand
Clermont-Ferrand, France
Hộpital Henri Mondor
Créteil, France
Hôpital Bicêtre
Le Kremlin-Bicêtre, France
Robert Salengro Hopital-CHRU Lille
Lille, France
CHU de Limoges
Limoges, France
Hôpital Edouard Herriot
Lyon, France
CHRU Nancy, Hôpital Central
Nancy, France
CHU de Nimes
Nîmes, France
Hôpital de la Source, CHR Orleans
Orléans, France
CHRU Bretonneau
Tours, France
Related Publications (1)
Bulger EM, May AK, Robinson BRH, Evans DC, Henry S, Green JM, Toschlog E, Sperry JL, Fagenholz P, Martin ND, Dankner WM, Maislin G, Wilfret D, Bernard AC; ACCUTE Study Investigators. A Novel Immune Modulator for Patients With Necrotizing Soft Tissue Infections (NSTI): Results of a Multicenter, Phase 3 Randomized Controlled Trial of Reltecimod (AB 103). Ann Surg. 2020 Sep 1;272(3):469-478. doi: 10.1097/SLA.0000000000004102.
PMID: 32657946RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Wayne M Dankner, MD, Chief Medical Officer
- Organization
- Atox Bio, Ltd.
Study Officials
- STUDY DIRECTOR
Wayne M Dankner, MD
Atox Bio Ltd
- PRINCIPAL INVESTIGATOR
Eileen M Bulger, MD
Harborview Injury Prevention and Research Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 6, 2015
First Posted
June 12, 2015
Study Start
December 1, 2015
Primary Completion
August 18, 2019
Study Completion
October 18, 2019
Last Updated
October 5, 2021
Results First Posted
October 5, 2021
Record last verified: 2021-10
Data Sharing
- IPD Sharing
- Will not share