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CompletedNCT00061438Updated Sep 1, 2017

A Study to Determine if Antibiotics Prevent Infection in the Pancreas of Patients Where Part of the Pancreas Has Died

A Phase 4 interventional study of meropenem in Pancreatitis, Acute Necrotizing, sponsored by Pfizer. Completed at 11 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-09-01.

Sponsored by Pfizer · Phase 4, Interventional, and Prevention

Phase
Phase 4
Study type
Interventional
Enrollment
240
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Pancreatitis, Acute Necrotizing

Keywords

  • non-infected necrotizing pancreatitis
  • pancreatic infection
  • peripancreatic infection
03

In context

Pancreatitis

752 studies on the registry are indexed under Pancreatitis; 181 are open to participants now.

This study's enrollment of 240 is above the median of 80 across 448 interventional studies indexed under Pancreatitis.

Browse Pancreatitis studies →

Lead sponsor

Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.

Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
240 participants

Interventions

  • Drugmeropenem
06

Study locations

11 sites
  • Research Site
    San Francisco, California, United States
  • Research Site
    Tampa, Florida, United States
  • Research Site
    Chicago, Illinois, United States
  • Research Site
    Baltimore, Maryland, United States
  • Research Site
    Boston, Massachusetts, United States
  • Research Site
    Worcester, Massachusetts, United States
  • Research Site
    Newark, New Jersey, United States
  • Research Site
    New York, New York, United States
  • Research Site
    Seattle, Washington, United States
  • Research Site
    Toronto, Ontario, Canada
  • Research Site
    Montreal, Quebec, Canada
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 1, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00061438
Lead sponsor
Pfizer
First posted
May 28, 2003
Start date
Feb 2003
Primary completion
Dec 2004
Completion
Dec 2004
Last update
Sep 1, 2017

Study contacts

AntiInfection Medical Science Director, MD
study director · AstraZeneca
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.

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