Back to resultsEvaluation of Pancreatic Tissue Penetration of Meronem® in the Prophylaxis of Septic Complications in Severe Pancreatitis
Primary Purpose
Pancreatitis
Status
Completed
Phase
Phase 4
Locations
Colombia
Study Type
Interventional
Intervention
Meropenem
Sponsored by
About this trial
This is an interventional treatment trial for Pancreatitis
Eligibility 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
Sites / Locations
- Research Site
Outcomes
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00318994
Brief Title
Evaluation of Pancreatic Tissue Penetration of Meronem® in the Prophylaxis of Septic Complications in Severe Pancreatitis
Official Title
Evaluation of Pancreatic Tissue Penetration of Meronem® in the Prophylaxis of Septic Complications in Severe Pancreatitis
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
February 2002 (undefined)
Primary Completion Date
September 2005 (Actual)
Study Completion Date
May 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Pfizer
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
6 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Meropenem
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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.
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AstraZeneca Columbia Medical Director, MD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Bogota
Country
Colombia
12. IPD Sharing Statement
Learn more about this trial
Evaluation of Pancreatic Tissue Penetration of Meronem® in the Prophylaxis of Septic Complications in Severe Pancreatitis
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