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.
1. Swab culture (skin, pharyngeal, nasal, anus) when administered into laminar flow room after transplantation. 2. Randomize the febrile patients into 2 groups. 3. Therapy group receive piperacillin/tazobactam, 4.5g q6h iv. Control group receive imipenem/cilastatin, 0.5g q6h. Duration will be 5-10 days.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
123
4.5g q6h, 5-10 days
0.5g q6h, 5-10 days
Chinese PLA general hospital
Beijing, Beijing Municipality, China
Clinical success rate.
Resolve of clinical symptoms and signs, without change of therapy.
Time frame: 3 weeks after beginning of empirical therapy
Microbiologic success rate
Microbiologic success includes eradication, suspected eradication, and super-infection. 1. 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 2. No eradication: one or more baseline pathogens were persistent 3. Relapse: the baseline pathogens transient absence reappeared during the therapy 4. Alternative: the baseline pathogens were eradicated, but new ones appeared without any clinical signs and symptoms 5. Re-infection: the baseline pathogens were eradicated, but new ones appeared with clinical signs and symptoms.
Time frame: 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.
Time frame: 3 weeks after beginning of empirical therapy
Cost of drug and therapy
Time frame: 3 weeks after beginning of empirical therapy
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