Evaluation of Pancreatic Tissue Penetration of Meronem® in the Prophylaxis of Septic Complications in Severe Pancreatitis

• Status: Completed
• Trial end date: 2007-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca; Pfizer
• Treatments: Meropenem

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