Evaluation of Pancreatic Tissue Penetration of Meronem® in the Prophylaxis of Septic Complications in Severe Pancreatitis
Information source: AstraZeneca
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pancreatitis
Intervention: Meropenem (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: AstraZeneca Official(s) and/or principal investigator(s):
AstraZeneca Columbia Medical Director, MD, Study Director, Affiliation: AstraZeneca
Summary
To measure meropenem pancreatic tissue penetration in subjects with severe pancreatitis
requiring surgery between 30 to 60 minutes after a bolus of 1 g IV meropenem given during the
induction period of anesthesia.
Clinical Details
Official title: Evaluation of Pancreatic Tissue Penetration of Meronem® in the Prophylaxis of Septic Complications in Severe Pancreatitis
Study design: Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Pharmacokinetics Study
Primary outcome: To measure meropenem pancreatic tissue penetration in subjects with severe pancreatitis requiring surgery between 30 and 60 minutes after a bolus of 1 g IV meropenem applied during induction of anesthesia.
Secondary outcome: To describe the incidence of infectious complications during the first 30 days after surgery in subjects with severe pancreatitis receiving IV meropenem at a dose of 1 g every 8 hours during 14 days.
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Subjects with diagnosis of severe pancreatitis requiring surgery according to the
protocol of each Institution.
- Informed consent signed by the subject
- Subjects who have received prophylactic antibiotics for previous invasive procedures
different from surgery may be included
Exclusion Criteria:
- Will of the subject not to be included
- Subjects who have not signed the informed consent
- Subjects with known hypersensibility to carbapenems, penicillins, or cephalosporins
Locations and Contacts
Research Site, Bogota, Colombia
Additional Information
Starting date: February 2002
Ending date: May 2007
Last updated: January 11, 2008
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