Ignite Creation Date:
2025-12-24 @ 6:59 PM
Ignite Modification Date:
2025-12-30 @ 2:56 AM
Study NCT ID:
NCT01714557
Status:
UNKNOWN
Last Update Posted:
2012-10-26
First Post:
2012-07-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prophylactic Piperacillin/Tazobactam in Hematopoietic Stem Cell Transplantation
Sponsor:
Chinese PLA General Hospital
Organization:
Study Overview
Official Title:
Piperacillin/Tazobactam for Prophylaxis in Patients of Neutropenia After Hematopoietic Stem Cell Transplantation - A Pilot Study
Status:
UNKNOWN
Status Verified Date:
2012-10
Last Known Status:
NOT_YET_RECRUITING
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:
Neutropenia is very common in patients received hematopoietic stem cell transplantation, with median duration of about 14 days. Almost all neutropenia will suffer from febrile without prophylactic antibiotics. IDSA recommended fluoroquinolones as prophylaxis in neutropenia patients of high risks, while in China, major pathogens possess high resistance to fluoroquinolones. It is not clear whether prophylaxis is of benefit, nor the appropriate prophylaxis regimen.
The current study will evaluate the three different regimen:
1. No prophylaxic antibiotic
2. Piperacillin as prophylaxis for neutropenia patients. Piperacillin has anti-pseudomonas activity.
3. Piperacillin/tazobactam as prophylaxis for neutropenia patients. Piperacillin/tazobactam has highest susceptibility rate among common anti-pseudomonas antibiotics.
The current study will evaluate the three different regimen:
1. No prophylaxic antibiotic
2. Piperacillin as prophylaxis for neutropenia patients. Piperacillin has anti-pseudomonas activity.
3. Piperacillin/tazobactam as prophylaxis for neutropenia patients. Piperacillin/tazobactam has highest susceptibility rate among common anti-pseudomonas antibiotics.
Detailed Description:
1. Swab culture (skin, pharyngeal, nasal, anus) when administered into laminar flow room after transplantation.
2. Randomize the neutropenia patients into 3 groups.
3. Receive 3 regimen.
4. Full record of clinical data, including background diseases, previous antibiotics within 90 days, febrile or not at the TOC.
5. For patients developed febrile, imipenem will be prescribed, even if the patient received no prophylaxis. At the same time, the follow-up ended.
2. Randomize the neutropenia patients into 3 groups.
3. Receive 3 regimen.
4. Full record of clinical data, including background diseases, previous antibiotics within 90 days, febrile or not at the TOC.
5. For patients developed febrile, imipenem will be prescribed, even if the patient received no prophylaxis. At the same time, the follow-up ended.
Study Oversight
Has Oversight DMC:
False
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?: