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

• ClinicalTrials.gov Identifier: NCT00318994
• Recruitment Status: Completed
• First Posted: April 27, 2006
• Last Update Posted: September 1, 2017
• Sponsor: Pfizer
• Information provided by: Pfizer

Tracking Information

• First Submitted Date: April 26, 2006
• First Posted Date: April 27, 2006
• Last Update Posted Date: September 1, 2017
• Study Start Date: February 2002
• Actual Primary Completion Date: September 2005 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: April 26, 2006): 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.
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures (submitted: April 26, 2006): 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.
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Pancreatitis
• Intervention: Drug: Meropenem
• Study Arms: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Enrollment (submitted: April 26, 2006): 6
• Original Enrollment: Same as current
• Actual Study Completion Date: May 2007
• Actual Primary Completion Date: September 2005 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: Child, Adult, Older Adult
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Colombia

Administrative Information

• NCT Number: NCT00318994
• Other Study ID Numbers: 3591/9010; D9211C09010
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Not Provided
• Study Sponsor: Pfizer
• Collaborators: Not Provided

Investigators

• Study Director: AstraZeneca Columbia Medical Director, MD; AstraZeneca

• PRS Account: Pfizer
• Verification Date: August 2017