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A study to determine if antibiotics prevent infection in the pancreas of patients where part of the pancreas has died. Clinical Trials Data presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, calls or treatment using a genuine doctor. We are not docs. Always consult your dr. on A study to determine if antibiotics prevent infection in the pancreas of patients where part of the pancreas has died. conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. A study to determine if antibiotics prevent infection in the pancreas of patients where part of the pancreas has died. Clinical research trials and A study to determine if antibiotics prevent infection in the pancreas of patients where part of the pancreas has died. healthcare trials occur in a lot of of places throughout the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the potency of new drugs. The intent of the studies / undertakings is to figure out certain human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector corporations to locate remedies for all kinds of circumstances, including A study to determine if antibiotics prevent infection in the pancreas of patients where part of the pancreas has died.. A study to determine if antibiotics prevent infection in the pancreas of patients where part of the pancreas has died. Clinical Trials and other clinical trials allow volunteers to obtain health treatment alternatives before they are available to the masses. Many times the participants undergo treatment for free, and sometimes they are paid for their time. Occasionally there is a cost for a A study to determine if antibiotics prevent infection in the pancreas of patients where part of the pancreas has died. clinical trial. Participants typically obtain the most effective healthcare available for their A study to determine if antibiotics prevent infection in the pancreas of patients where part of the pancreas has died. condition. Dangers are a reality, nonetheless, and can include extra or frequent mD trips, medical hazards (potentially life-endangering), and/or the treatment being uneffective. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "A" Clinical Trials Conditions > A study to determine if antibiotics prevent infection in the pancreas of patients where part of the pancreas has died.  A study to determine if antibiotics prevent infection in the pancreas of patients where part of the pancreas has died.
A study to determine if antibiotics prevent infection in the pancreas of patients where part of the pancreas has died.
For Condition: Pancreatitis, Acute Necrotizing
Status: Recruiting
Sponsor(s): AstraZeneca ,
Synopsis: 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.
Details:
Eligibility:
Study Type: Interventional, Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: - Subjects male or female, 18 years of age or older. - Diagnosis of necrotizing pancreatitis within 120 hours following onset of symptoms 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
Total Enrollment: 240
Location and Contact Information:
Additional Information:
Study ID Numbers: 3591IL/0089; 89
Study Start Date:
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00061438
Other Pancreatitis, Acute Necrotizing Studies:
1. Videoscopic Drainage of Infected Pancreatic Collections
2. A study to determine if antibiotics prevent infection in the pancreas of patients where part of the pancreas has died.
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A study to determine if antibiotics prevent infection in the pancreas of patients where part of the pancreas has died.
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