Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00061438
Status:
COMPLETED
Last Update Posted:
2017-09-01
First Post:
2003-05-27
Brief Title:
A Study to Determine if Antibiotics Prevent Infection in the Pancreas of Patients Where Part of the Pancreas Has Died
Sponsor:
Pfizer
Organization:
Pfizer
Study Overview
Official Title:
A Multicentre Randomised Double-blind Placebo-controlled Study on the Use of Prophylactic Meropenem Therapy in Subjects With Severe Acute Necrotizing Pancreatitis
Status:
COMPLETED
Status Verified Date:
2017-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 IV 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
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 IV 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 Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 89 | None | None | None |