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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00318994
First received: April 26, 2006
Last updated: January 11, 2008
Last verified: January 2008
  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 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of Pancreatic Tissue Penetration of Meronem® in the Prophylaxis of Septic Complications in Severe Pancreatitis

Resource links provided by NLM:


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

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

Additional relevant MeSH terms:
Pancreatitis
Pancreatic Diseases
Digestive System Diseases
Meropenem
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 23, 2014