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

Pfizer6 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Pancreatitis

Interventions

MeropenemDRUG

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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 (1)

Research Site

Bogotá, Colombia

Outcomes

Primary Outcomes

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 Outcomes

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.

Data from ClinicalTrials.gov

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