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

Information source: AstraZeneca
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pancreatitis

Intervention: Meropenem (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
AstraZeneca Columbia Medical Director, MD, Study Director, Affiliation: AstraZeneca

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.

Clinical Details

Official title: Evaluation of Pancreatic Tissue Penetration of Meronem« in the Prophylaxis of Septic Complications in Severe Pancreatitis

Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: 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: 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

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Research Site, Bogota, Colombia
Additional Information

Starting date: February 2002
Last updated: January 11, 2008

Page last updated: August 23, 2015

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