NCT00061438

Brief Summary

This is a research study in patients having a condition known as necrotizing pancreatitis. This is inflammation of the pancreas (an intestinal organ which assists with digestion) that has resulted in the damage and death of some pancreatic tissue. This damaged pancreatic tissue may develop a bacterial infection, which can cause further -sometimes very serious- health problems. It may be possible to prevent or delay infection by giving 'prophylactic' antibiotics (that is - to provide protection before any infection starts). However, it is not certain that this antibiotic therapy will be successful. This study is being carried out to see whether the antibiotic 'Meropenem' (which is also known as MERREM I.V.) provides protection from developing a pancreatic infection. This will be done by comparing the progress of patients who receive meropenem with those who receive a non-active placebo solution (a solution that does not contain any active medication). Meropenem or placebo would be given in addition to the standard treatment received for pancreatitis. It is not known if meropenem will help prevent infections associated with necrotizing pancreatitis. Approximately 240 patients will take part in this study. Study participation will be carried out for up to 6 weeks, and patients will receive the study treatment up to a maximum of 21 days.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
240

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Feb 2003

Geographic Reach
2 countries

11 active sites

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, 2003

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 27, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 28, 2003

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2004

Completed
Last Updated

September 1, 2017

Status Verified

August 1, 2017

Enrollment Period

1.8 years

First QC Date

May 27, 2003

Last Update Submit

August 31, 2017

Conditions

Pancreatitis, Acute Necrotizing

Keywords

non-infected necrotizing pancreatitispancreatic infectionperipancreatic infection

Interventions

meropenemDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of necrotizing pancreatitis within 120 hours following onset of symptoms/first reported symptoms.
  • Primary diagnosis to be confirmed by contrast-enhanced CT evidence of 30% necrosis of the pancreas.
  • Or if \> or equal to 30% necrosis is not present or cannot be confirmed, a contrast enhanced CT scan showing extensive or multiple pancreatic fluid collections and pancreatic edema (Balthazar Grade E) with either C-reactive protein (CRP). 120 mg/L or a MOD score of \> 2 is acceptable.

You may not qualify if:

  • Received an investigational drug or device within 30 days prior to entering study.
  • Received \> 48 hours of antibiotic therapy between onset of symptoms of pancreatitis and diagnosis of necrotizing pancreatitis.
  • The subject has known or suspected anaphylactic or other type 1 (immediate) hypersensitivity reactions to cephalosporins, penicillins or carbapenems.
  • The subject is receiving, or will require, probenecid therapy.
  • The subject is neutropenic (absolute neutrophil count \< 1000/mm 3).
  • The subject has cirrhosis, severity of Child's grade C.
  • There is not a commitment on the part of the clinical care team, the subject, or the subject's family to full, aggressive support including operative intervention if needed.
  • The subject is a pregnant and/or nursing female

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Research Site

San Francisco, California, United States

Location

Research Site

Tampa, Florida, United States

Location

Research Site

Chicago, Illinois, United States

Location

Research Site

Baltimore, Maryland, United States

Location

Research Site

Boston, Massachusetts, United States

Location

Research Site

Worcester, Massachusetts, United States

Location

Research Site

Newark, New Jersey, United States

Location

Research Site

New York, New York, United States

Location

Research Site

Seattle, Washington, United States

Location

Research Site

Toronto, Ontario, Canada

Location

Research Site

Montreal, Quebec, Canada

Location

MeSH Terms

Conditions

Pancreatitis, Acute Necrotizing

Interventions

Meropenem

Condition Hierarchy (Ancestors)

PancreatitisPancreatic DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

  • AntiInfection Medical Science Director, MD

    AstraZeneca

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 27, 2003

First Posted

May 28, 2003

Study Start

February 1, 2003

Primary Completion

December 1, 2004

Study Completion

December 1, 2004

Last Updated

September 1, 2017

Record last verified: 2017-08

Locations

CA(2)US(9)