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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-02-28

Study Completion Date

2007-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Pancreatitis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Meropenem

Intervention Type DRUG

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

No