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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
150
4.0g q8h 3-5 days
4.5g q8h 3-5 days
Chinese PLA general hospital
Beijing, Beijing Municipality, China
febrile rate
In both group, how many patients developed febrile.
Time frame: 3 weeks after beginning of prophylaxis
Microbiologic efficacy in febrile patients
The success rate and failure rate will be calculated. 1. The microbiologic culture is positive at 3 weeks of prophylaxis, showing pathogen sensitive to Piperacillin/tazobactam, the case will be evaluated as breakthrough infection, that means microbiologic failure. 2. The microbiologic culture is negative at 3 weeks of prophylaxis,, or positive fungus or non-typical organisms, the case will be evaluated as microbiologic success.
Time frame: 3 weeks after beginning of prophylaxis
Recovery rate from neutropenia
How many patients reached the ANC \> 0.5×109/L more than 3 days.
Time frame: 3 weeks after beginning of prophylaxis
AE
How many patients developed unexpected medical events.
Time frame: 3 weeks after beginning of prophylaxis
Cost of drug and hospital-stay
Time frame: 3 weeks after beginning of prophylaxis
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