NCT00318994

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Feb 2002

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2002

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2005

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

April 26, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 27, 2006

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
Last Updated

September 1, 2017

Status Verified

August 1, 2017

Enrollment Period

3.6 years

First QC Date

April 26, 2006

Last Update Submit

August 31, 2017

Conditions

Pancreatitis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • 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.

Interventions

MeropenemDRUG

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Bogotá, Colombia

Location

MeSH Terms

Conditions

Pancreatitis

Interventions

Meropenem

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

ThienamycinsCarbapenemsbeta-LactamsLactamsAmidesOrganic ChemicalsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • AstraZeneca Columbia Medical Director, MD

    AstraZeneca

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 26, 2006

First Posted

April 27, 2006

Study Start

February 1, 2002

Primary Completion

September 1, 2005

Study Completion

May 1, 2007

Last Updated

September 1, 2017

Record last verified: 2017-08

Locations

CO(1)