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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00061438
First received: May 27, 2003
Last updated: November 17, 2010
Last verified: November 2010
  Purpose

This is a research study in patients having a condition known as necrotizing pancreatitis. This is inflammation of the pancreas (an intestinal organ which assists with digestion) that has resulted in the damage and death of some pancreatic tissue. This damaged pancreatic tissue may develop a bacterial infection, which can cause further -sometimes very serious- health problems.

It may be possible to prevent or delay infection by giving 'prophylactic' antibiotics (that is - to provide protection before any infection starts). However, it is not certain that this antibiotic therapy will be successful.

This study is being carried out to see whether the antibiotic 'Meropenem' (which is also known as MERREM I.V.) provides protection from developing a pancreatic infection. This will be done by comparing the progress of patients who receive meropenem with those who receive a non-active placebo solution (a solution that does not contain any active medication).

Meropenem or placebo would be given in addition to the standard treatment received for pancreatitis.

It is not known if meropenem will help prevent infections associated with necrotizing pancreatitis.

Approximately 240 patients will take part in this study.

Study participation will be carried out for up to 6 weeks, and patients will receive the study treatment up to a maximum of 21 days.


Condition Intervention Phase
Pancreatitis, Acute Necrotizing
Drug: meropenem
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: A Multicentre, Randomised, Double-blind, Placebo-controlled, Study on the Use of Prophylactic Meropenem Therapy in Subjects With Severe Acute Necrotizing Pancreatitis

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Estimated Enrollment: 240
Study Start Date: February 2003
Study Completion Date: December 2004
Primary Completion Date: December 2004 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00061438

Locations
United States, California
Research Site
San Francisco, California, United States
United States, Florida
Research Site
Tampa, Florida, United States
United States, Illinois
Research Site
Chicago, Illinois, United States
United States, Maryland
Research Site
Baltimore, Maryland, United States
United States, Massachusetts
Research Site
Boston, Massachusetts, United States
Research Site
Worchester, Massachusetts, United States
United States, New Jersey
Research Site
Newark, New Jersey, United States
United States, New York
Research Site
New York, New York, United States
United States, Washington
Research Site
Seattle, Washington, United States
Canada, Ontario
Research Site
Toronto, Ontario, Canada
Canada, Quebec
Research Site
Montreal, Quebec, Canada
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: AntiInfection Medical Science Director, MD AstraZeneca
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00061438     History of Changes
Other Study ID Numbers: 3591IL/0089, 89
Study First Received: May 27, 2003
Last Updated: November 17, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
non-infected necrotizing pancreatitis
pancreatic infection
peripancreatic infection

Additional relevant MeSH terms:
Pancreatitis
Pancreatitis, Acute Necrotizing
Pancreatic Diseases
Digestive System Diseases
Meropenem
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014