A Study to Determine if Antibiotics Prevent Infection in the Pancreas of Patients Where Part of the Pancreas Has Died
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
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|
|United States, California|
|San Francisco, California, United States|
|United States, Florida|
|Tampa, Florida, United States|
|United States, Illinois|
|Chicago, Illinois, United States|
|United States, Maryland|
|Baltimore, Maryland, United States|
|United States, Massachusetts|
|Boston, Massachusetts, United States|
|Worchester, Massachusetts, United States|
|United States, New Jersey|
|Newark, New Jersey, United States|
|United States, New York|
|New York, New York, United States|
|United States, Washington|
|Seattle, Washington, United States|
|Toronto, Ontario, Canada|
|Montreal, Quebec, Canada|
|Study Director:||AntiInfection Medical Science Director, MD||AstraZeneca|