drugset / Trial / NCT01714557

Prophylactic Piperacillin/Tazobactam in Hematopoietic Stem Cell Transplantation

NCT01714557

Unknown 150 enrolled Chinese PLA General Hospital
RandomizedParallel-groupOpen-labelPrevention

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.

Timeline

Start
2012-09
Primary completion
2014-09
Completion
2014-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Amoxicillin Other / unclassified 4.5 g
Comparator Piperacillin Small molecule 4 g