Study identifier:3591IL/0089
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
A Multicentre, Randomised, Double-blind, Placebo-controlled, Study on the Use of Prophylactic Meropenem Therapy in Subjects with Severe Acute Necrotizing Pancreatitis
Pancreatitis, Acute Necrotizing
Phase 4
No
meropenem
All
240
Interventional
18 Years +
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Prevention
Verified 01 Nov 2010 by AstraZeneca Pharmaceuticals
AstraZeneca Pharmaceuticals
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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.
Location
Location
Seattle, WA, United States
Location
Boston, MA, United States
Location
Newark, NJ, United States
Location
Chicago, IL, United States
Location
New York, NY, United States
Location
Tampa, FL, United States
Location
Baltimore, MD, United States
Location
San Francisco, CA, United States
Arms | Assigned Interventions |
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