![]() ![]() ![]() Patient or patient's family are not committed to aggressive management of the patient's condition Īny 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:.Patient is not expected to survive throughout 28 days of study due to underlying medical condition, such as poorly controlled neoplasm.Patients with cardiac arrest requiring cardiopulmonary resuscitation within the past 30 days.Recent cerebrovascular accident in the last 3 months.Chronic neurological impairment that leads to a neuro mSOFA component ≥2.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 Removed deep vein thrombosis (DVT) in area of NSTI as an exclusion criteria.Diabetic patients with peripheral vascular disease who present with below the ankle infection.Patients with overt peripheral vascular disease in the involved area.Patient who has been operated at least once for the current NSTI infection and had a curative deep tissue debridement.If patient is unable to comprehend or sign the ICF, patient's legally acceptable representative may sign the ICF Signed and dated informed consent (ICF) as defined by the Institutional Review Board (IRB) and, if applicable, California Bill of Rights.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.If a woman is of childbearing potential, she must consistently use an acceptable method of contraception from baseline through Day 28.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).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.Surgical confirmation of NSTI by attending surgeon.The study will be conducted with interim analyses for futility at 100 patients and safety monitored by an independent Data Monitoring Board at regular planned intervals. Randomization will be stratified within center by the diagnosis of Fournier's Gangrene and mSOFA score category (3-4 vs >4) at screening. A patient will be required to have had no amputations done after the first surgical procedure in order to achieve composite clinical success.Ģ90 patients will be recruited into the study and randomized to receive either 0.5 mg/kg AB103 or placebo in a 1:1 ratio. No amputation after the first debridement (amputation on the first debridement is not considered a failure). No more than 3 debridements to Day 14 will be required for a patient to achieve composite clinical success Reduced number of debridements, counted to Day 14.Improve the local signs of the infection, as measured by: 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) Modified SOFA (mSOFA) score on Day 14 and change from baseline to Day 14 ≥ 3.Improve systemic signs of the infection by improving organ function of patients compared to placebo as measured by: These analyses are designed to demonstrate that in addition to being safe, one dose of 0.5 mg/kg of AB103 will: 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. 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. 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. Why Should I Register and Submit Results?. ![]()
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