Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003805
Status:
COMPLETED
Last Update Posted:
2012-09-24
First Post:
1999-11-01
Brief Title:
Prevention of Infection in Patients With Hematologic Cancer and Persistent Fever Caused by a Low White Blood Cell Count
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Organization:
European Organisation for Research and Treatment of Cancer - EORTC
Study Overview
Official Title:
Vancomycin Versus Placebo in Persistently Febrile Granulocytopenic Patients Given PiperacillinTazobactam
Status:
COMPLETED
Status Verified Date:
2012-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Antibiotic therapy may prevent the development of infection in patients with hematologic cancer and the persistent fever caused by a low white blood cell count It is not yet known which regimen of antibiotics is most effective in preventing infection in these patients
PURPOSE Randomized phase III trial to study the effectiveness of piperacillin-tazobactam with or without vancomycin in reducing fever in patients who have leukemia lymphoma or Hodgkins disease
PURPOSE Randomized phase III trial to study the effectiveness of piperacillin-tazobactam with or without vancomycin in reducing fever in patients who have leukemia lymphoma or Hodgkins disease
Detailed Description:
OBJECTIVES I Compare the efficacy of piperacillin and tazobactam with or without vancomycin in reducing fever in patients with hematological malignancies and persistent febrile granulocytopenia
OUTLINE This is a randomized double blind multicenter study Patients receive piperacillintazobactam IV over 20-30 minutes every 6 hours Patients who become afebrile within 48-60 hours after beginning treatment continue to receive piperacillintazobactam alone These afebrile patients continue treatment for a minimum of 7 days of which 4 must be consecutive without fever Patients who are still febrile after the initial 48-60 hours are randomized to continue on piperacillintazobactam alone or with vancomycin Vancomycin IV is administered over at least 1 hour twice daily Treatment continues for a maximum of 28 days in the absence of persistent fever Patients are followed at 7-10 days after completion of therapy
PROJECTED ACCRUAL A total of 500 patients will be accrued for this study
OUTLINE This is a randomized double blind multicenter study Patients receive piperacillintazobactam IV over 20-30 minutes every 6 hours Patients who become afebrile within 48-60 hours after beginning treatment continue to receive piperacillintazobactam alone These afebrile patients continue treatment for a minimum of 7 days of which 4 must be consecutive without fever Patients who are still febrile after the initial 48-60 hours are randomized to continue on piperacillintazobactam alone or with vancomycin Vancomycin IV is administered over at least 1 hour twice daily Treatment continues for a maximum of 28 days in the absence of persistent fever Patients are followed at 7-10 days after completion of therapy
PROJECTED ACCRUAL A total of 500 patients will be accrued for this study
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 |
|---|---|---|---|
| EORTC-46971 | None | None | None |