A Multicentre, Randomised, Double-blind, Placebo-controlled, Study on the Use of Prophylactic Meropenem Therapy in Subjects With Severe Acute Necrotizing Pancreatitis
A Study to Determine if Antibiotics Prevent Infection in the Pancreas of Patients Where Part of the Pancreas Has Died
Sponsors
Source
Pfizer
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.
Overall Status
Completed
Start Date
2003-02-01
Completion Date
2004-12-01
Primary Completion Date
2004-12-01
Phase
Phase 4
Study Type
Interventional
Enrollment
240
Condition
Intervention
Eligibility
Criteria
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:
- 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
Gender
All
Minimum Age
18 Years
Maximum Age
N/A
Healthy Volunteers
No
Overall Official
Last Name |
Role |
Affiliation |
|
AntiInfection Medical Science Director, MD |
Study Director |
AstraZeneca |
Location
Facility |
|
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 |
Location Countries
Country
Canada
United States
Verification Date
2017-08-01
Lastchanged Date
N/A
Firstreceived Date
N/A
Keywords
Condition Browse
Secondary Id
89
Intervention Browse
Mesh Term
Meropenem
Firstreceived Results Date
N/A
Firstreceived Results Disposition Date
N/A
Study Design Info
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Prevention
Masking
Double
Study First Submitted
May 27, 2003
Study First Submitted Qc
May 27, 2003
Study First Posted
May 28, 2003
Last Update Submitted
August 31, 2017
Last Update Submitted Qc
August 31, 2017
Last Update Posted
September 1, 2017
ClinicalTrials.gov processed this data on December 06, 2019
Conditions
Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov,
conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions
Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied.
Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase
Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions
that study is seeking to answer:
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.