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

Pfizer

Status and phase: Completed; Phase 4

Conditions: Pancreatitis

Treatments: Drug: Meropenem

Study type: Interventional

Funder types: Industry

Identifiers

NCT00318994

3591/9010

D9211C09010

Details and patient eligibility

About

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.

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)