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

This study has been completed.

First Received: April 26, 2006 Last Updated: January 11, 2008 History of Changes

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00318994

Purpose

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.

Condition	Intervention	Phase
Pancreatitis	Drug: Meropenem	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Pharmacokinetics Study
Official Title:	Evaluation of Pancreatic Tissue Penetration of Meronem® in the Prophylaxis of Septic Complications in Severe Pancreatitis

Resource links provided by NLM:

MedlinePlus related topics: Anesthesia Surgery

Drug Information available for: Meropenem

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

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:

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.

Estimated Enrollment:	6
Study Start Date:	February 2002
Study Completion Date:	May 2007
Primary Completion Date:	September 2005 (Final data collection date for primary outcome measure)

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00318994

Locations

Colombia
Research Site
Bogota, Colombia

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

AstraZeneca Columbia Medical Director, MD

AstraZeneca

More Information

No publications provided

Study ID Numbers:	3591/9010, D9211C09010
Study First Received:	April 26, 2006
Last Updated:	January 11, 2008
ClinicalTrials.gov Identifier:	NCT00318994 History of Changes
Health Authority:	Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos

Additional relevant MeSH terms:

Anti-Infective Agents
Anti-Bacterial Agents
Digestive System Diseases
Therapeutic Uses

Meropenem
Pancreatic Diseases
Pharmacologic Actions
Pancreatitis

ClinicalTrials.gov processed this record on February 08, 2010