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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00318994
Recruitment Status : Completed
First Posted : April 27, 2006
Last Update Posted : September 1, 2017
Sponsor:
Information provided by:
Pfizer

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Pancreatitis Drug: Meropenem Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 6 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Pancreatic Tissue Penetration of Meronem® in the Prophylaxis of Septic Complications in Severe Pancreatitis
Study Start Date : February 2002
Actual Primary Completion Date : September 2005
Actual Study Completion Date : May 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pancreatitis
Drug Information available for: Meropenem

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. 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.

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00318994


Locations
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Colombia
Research Site
Bogota, Colombia
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: AstraZeneca Columbia Medical Director, MD AstraZeneca
More Information
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ClinicalTrials.gov Identifier: NCT00318994    
Other Study ID Numbers: 3591/9010
D9211C09010
First Posted: April 27, 2006    Key Record Dates
Last Update Posted: September 1, 2017
Last Verified: August 2017
Additional relevant MeSH terms:
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Pancreatitis
Pancreatic Diseases
Digestive System Diseases
 Meropenem
Anti-Bacterial Agents
Anti-Infective Agents