Prophylactic Piperacillin/Tazobactam in Hematopoietic Stem Cell Transplantation
NCT01714557 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150
Last updated 2012-10-26
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.
Conditions
- Neutropenia
- Hematopoietic Stem Cell Transplantation
Interventions
- DRUG
-
Piperacillin
4.0g q8h 3-5 days
- DRUG
-
Piperacillin-tazobactam combination product
4.5g q8h 3-5 days
Sponsors & Collaborators
-
Chinese PLA General Hospital
lead OTHER
Principal Investigators
-
wenrong huang, Doctor · Employee
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 13 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2012-09-30
- Primary Completion
- 2014-09-30
- Completion
- 2014-11-30
Countries
- China
Study Locations
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