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

Phase 4

Completed

• Conditions: Pancreatitis

• Registration Number: NCT00318994
• Lead Sponsor: Pfizer

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-02
• Primary Completion: 2005-09
• Study First Submitted: 2006-04-26
• Study First Submitted QC: 2006-04-26
• Study First Posted: 2006-04-27
• Study Completion: 2007-05
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-31
• Last Update Posted: 2017-09-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Research Site; 🇨🇴 Bogota, Colombia