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

Pancreatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00318994
• Other study ID #: 3591/9010
• Secondary ID: D9211C09010
• Status: Completed
• Phase: Phase 4
• First received: April 26, 2006
• Last updated: August 31, 2017
• Start date: February 2002
• Est. completion date: May 2007

Study information

• Verified date: August 2017
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: May 2007
• Est. primary completion date: September 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Pancreatitis

Intervention

Drug:
• Meropenem

Locations

Country	Name	City	State
Colombia	Research Site	Bogota

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Colombia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.