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

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 IV

MedlinePlus related topics:

Antibiotics

Drug Information available for:

Meropenem Pancrelipase Ultrase

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Official Title:	A Multicentre, Randomised, Double-Blind, Placebo-Controlled, Study on the Use of Prophylactic Meropenem Therapy in Subjects With Severe Acute Necrotizing Pancreatitis

Further study details as provided by AstraZeneca:

Estimated Enrollment:

240

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

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

Contact the US Information Center at AstraZeneca This link exits the ClinicalTrials.gov site

Study ID Numbers:	3591IL/0089, 89
First Received:	May 27, 2003
Last Updated:	April 4, 2008
ClinicalTrials.gov Identifier:	NCT00061438
Health Authority:	United States: Food and Drug Administration

Keywords provided by AstraZeneca:

non-infected necrotizing pancreatitis

pancreatic infection

peripancreatic infection

Study placed in the following topic categories:

Death

Digestive System Diseases

Pancreatitis, Acute Necrotizing

Meropenem

Pancreatic Diseases

Pancrelipase

Pancreatitis

Additional relevant MeSH terms:

Anti-Infective Agents

Anti-Bacterial Agents

Therapeutic Uses

Pharmacologic Actions

ClinicalTrials.gov processed this record on November 30, 2008

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00061438