Phase III Efficacy and Safety Study of AB103 in the Treatment of Patients With Necrotizing Soft T… (NCT02469857) | Clinical Trial Compass
CompletedPhase 3
Phase III Efficacy and Safety Study of AB103 in the Treatment of Patients With Necrotizing Soft Tissue Infections
United States290 participantsStarted 2015-12-01
Plain-language 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.
Who can participate
Age range12 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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
Exclusion criteria
✕. 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;
What they're measuring
1
Number of Patients Achieving Necrotizing Infections Clinical Composite Endpoint (NICCE)
✕. Removed deep vein thrombosis (DVT) in area of NSTI as an exclusion criteria
✕. 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;