A Study to Determine if Antibiotics Prevent Infection in the Pancreas of Patients Where Part of the Pancreas Has Died
Pancreatitis, Acute Necrotizing
About this trial
This is an interventional prevention trial for Pancreatitis, Acute Necrotizing focused on measuring non-infected necrotizing pancreatitis, pancreatic infection, peripancreatic infection
Eligibility Criteria
Inclusion Criteria: Diagnosis of necrotizing pancreatitis within 120 hours following onset of symptoms/first reported symptoms. Primary diagnosis to be confirmed by contrast-enhanced CT evidence of 30% necrosis of the pancreas. Or if > or equal to 30% necrosis is not present or cannot be confirmed, a contrast enhanced CT scan showing extensive or multiple pancreatic fluid collections and pancreatic edema (Balthazar Grade E) with either C-reactive protein (CRP). 120 mg/L or a MOD score of > 2 is acceptable. Exclusion Criteria: Received an investigational drug or device within 30 days prior to entering study. Received > 48 hours of antibiotic therapy between onset of symptoms of pancreatitis and diagnosis of necrotizing pancreatitis. The subject has known or suspected anaphylactic or other type 1 (immediate) hypersensitivity reactions to cephalosporins, penicillins or carbapenems. The subject is receiving, or will require, probenecid therapy. The subject is neutropenic (absolute neutrophil count < 1000/mm 3). The subject has cirrhosis, severity of Child's grade C. There is not a commitment on the part of the clinical care team, the subject, or the subject's family to full, aggressive support including operative intervention if needed. The subject is a pregnant and/or nursing female
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