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

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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Key information

Conditions

Pancreatitis Digestive System Diseases Pancreatic Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Research Site

Bogotá, Colombia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Meropenem

Drug

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.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Important dates

Study start: 2002
Primary completion: 2005
Study completion: 2007
First posted: Apr 27, 2006
Registry last updated: Sep 1, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed