Piperacillin/Tazobactam for Empirical Therapy of Febrile Neutropenia

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. In 2010 update, IDSA recommended Piperacillin/tazobactam as first-line mono-therapy for febrile patients with neutropenia of high risk. In china, the data of piperacillin/tazobactam for febrile neutropenia after hematopoietic stem cell transplantation is very limited. The current study will evaluate the efficacy of piperacillin/tazobactam compared with imipenem/cilastatin for febrile neutropenia after transplantation.

Detailed Description
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Swab culture (skin, pharyngeal, nasal, anus) when administered into laminar flow room after transplantation. Randomize the febrile patients into 2 groups. Therapy group receive piperacillin/tazobactam, 4.5g q6h iv. Control group receive imipenem/cilastatin, 0.5g q6h. Duration will be 5-10 days.

Official Title
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A Prospective, Randomized, Open Label Study of Piperacillin/Tazobactam Versus Imipenem/Cilastin for Empirical Therapy of Febrile Patients With Neutropenia After Hematopoietic Stem Cell Transplantation

Conditions
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Febrile, Neutropenia, Hematopoietic Stem Cell Transplantation

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


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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: piperacillin/tazobactam<br> | Drug: Piperacillin-tazobactam combination product<br>* 4.5g q6h, 5-10 days<br>* Other names: Tazocin;|
| Active Comparator: imipenem/cilastatin<br> | Drug: Imipenem<br>* 0.5g q6h, 5-10 days<br>* Other names: Tienam;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical success rate. | Resolve of clinical symptoms and signs, without change of therapy. | 3 weeks after beginning of empirical therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Microbiologic success rate | Microbiologic success includes eradication, suspected eradication, and super-infection. Eradication or Presumed eradication: the baseline pathogens no longer present on the culture performed after completion of treatment. If no way to collect biologic sample(s) after treatment;, e.g. sputum, a presumed eradication will be concluded No eradication: one or more baseline pathogens were persistent Relapse: the baseline pathogens transient absence reappeared during the therapy Alternative: the baseline pathogens were eradicated, but new ones appeared without any clinical signs and symptoms Re-infection: the baseline pathogens were eradicated, but new ones appeared with clinical signs and symptoms. | 3 weeks after beginning of empirical therapy | 
| Adverse effect | The number of patients developed unexpected medical information at the 3 weeks after beginning of empirical therapy. | 3 weeks after beginning of empirical therapy | 
| Cost of drug and therapy |  | 3 weeks after beginning of empirical therapy |