- 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.
- 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
- 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