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Trial record 1 of 1 for:    NCT00318994
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Evaluation of Pancreatic Tissue Penetration of Meronem® in the Prophylaxis of Septic Complications in Severe Pancreatitis

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

Tracking Information
First Submitted Date  ICMJE April 26, 2006
First Posted Date  ICMJE April 27, 2006
Last Update Posted Date September 1, 2017
Study Start Date  ICMJE February 2002
Actual Primary Completion Date September 2005   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of Pancreatic Tissue Penetration of Meronem® in the Prophylaxis of Septic Complications in Severe Pancreatitis
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Pancreatitis
Intervention  ICMJE Drug: Meropenem
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: April 26, 2006)
6
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2007
Actual Primary Completion Date September 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Colombia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00318994
Other Study ID Numbers  ICMJE 3591/9010
D9211C09010
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: AstraZeneca Columbia Medical Director, MD AstraZeneca
PRS Account Pfizer
Verification Date August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP