Prophylactic Piperacillin/Tazobactam in Hematopoietic Stem Cell Transplantation

Study Overview
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Brief Summary
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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: No prophylaxic antibiotic Piperacillin as prophylaxis for neutropenia patients. Piperacillin has anti-pseudomonas activity. Piperacillin/tazobactam as prophylaxis for neutropenia patients. Piperacillin/tazobactam has highest susceptibility rate among common anti-pseudomonas antibiotics.

Detailed Description
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Swab culture (skin, pharyngeal, nasal, anus) when administered into laminar flow room after transplantation. Randomize the neutropenia patients into 3 groups. Receive 3 regimen. Full record of clinical data, including background diseases, previous antibiotics within 90 days, febrile or not at the TOC. For patients developed febrile, imipenem will be prescribed, even if the patient received no prophylaxis. At the same time, the follow-up ended.

Official Title
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Piperacillin/Tazobactam for Prophylaxis in Patients of Neutropenia After Hematopoietic Stem Cell Transplantation - A Pilot Study

Conditions
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Neutropenia, Hematopoietic Stem Cell Transplantation

Intervention / Treatment
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* Drug: Piperacillin
* Drug: Piperacillin-tazobactam combination product


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 13-65 years Received Autologous or Allogeneic hematopoietic stem cell transplantation. ECOG score 0-1. ICF is available. Exclusion Criteria: Allergic to any therapy drug. Documented infection before neutropenia. Renal dysfunction. Suffering from central nervous system or mental disease.

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: No prophylaxis<br> | |
| Active Comparator: piperacillin<br> | Drug: Piperacillin<br>* 4.0g q8h 3-5 days<br>|
| Experimental: piperacillin/tazobactam<br> | Drug: Piperacillin-tazobactam combination product<br>* 4.5g q8h 3-5 days<br>* Other names: Tazocin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| febrile rate | In both group, how many patients developed febrile. | 3 weeks after beginning of prophylaxis | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Microbiologic efficacy in febrile patients | The success rate and failure rate will be calculated. 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. 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. | 3 weeks after beginning of prophylaxis | 
| Recovery rate from neutropenia | How many patients reached the ANC > 0.5×109/L more than 3 days. | 3 weeks after beginning of prophylaxis | 
| AE | How many patients developed unexpected medical events. | 3 weeks after beginning of prophylaxis | 
| Cost of drug and hospital-stay |  | 3 weeks after beginning of prophylaxis |