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

Last updated on November 16, 2019

FOR MORE INFORMATION
Study Location
Research Site
San Francisco, California, United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Acute Necrotizing Pancreatitis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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

- 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

NCT00061438
Pfizer
Completed
A Study to Determine if Antibiotics Prevent Infection in the Pancreas of Patients Where Part of the Pancreas Has Died

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Descriptive Information
Brief Title  ICMJE A Study to Determine if Antibiotics Prevent Infection in the Pancreas of Patients Where Part of the Pancreas Has Died
Official Title  ICMJE A Multicentre, Randomised, Double-blind, Placebo-controlled, Study on the Use of Prophylactic Meropenem Therapy in Subjects With Severe Acute Necrotizing Pancreatitis
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.

Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Condition  ICMJE Pancreatitis, Acute Necrotizing
Intervention  ICMJE Drug: meropenem
Study Arms  ICMJE Not Provided
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: June 23, 2005)
240
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2004
Actual Primary Completion DateDecember 2004   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00061438
Other Study ID Numbers  ICMJE 3591IL/0089
89
Has Data Monitoring CommitteeNot Provided
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyNot Provided
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:AntiInfection Medical Science Director, MDAstraZeneca
PRS AccountPfizer
Verification DateAugust 2017

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

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Contact

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