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A Study to Determine if Antibiotics Prevent Infection in the Pancreas of Patients Where Part of the Pancreas Has Died

Last updated on February 23, 2019

FOR MORE INFORMATION
Study Location
Research Site
San Francisco, California, United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Acute Necrotizing Pancreatitis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
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- 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

NCT00061438
Pfizer
Completed
A Study to Determine if Antibiotics Prevent Infection in the Pancreas of Patients Where Part of the Pancreas Has Died

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Pfizer Clinical Trials Contact Center

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[email protected]

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Acute Necrotizing Pancreatitis
NCT00061438
All Genders
18+
Years
Multiple Sites

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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