Piperacillin/Tazobactam for Empirical Therapy of Febrile Neutropenia
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.
|Febrile Neutropenia Hematopoietic Stem Cell Transplantation||Drug: Piperacillin-tazobactam combination product Drug: Imipenem|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- Clinical success rate. [ Time Frame: 3 weeks after beginning of empirical therapy ]Resolve of clinical symptoms and signs, without change of therapy.
- Microbiologic success rate [ Time Frame: 3 weeks after beginning of empirical therapy ]
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.
- Adverse effect [ Time Frame: 3 weeks after beginning of empirical therapy ]The number of patients developed unexpected medical information at the 3 weeks after beginning of empirical therapy.
- Cost of drug and therapy [ Time Frame: 3 weeks after beginning of empirical therapy ]
|Study Start Date:||November 2012|
|Study Completion Date:||April 2014|
|Primary Completion Date:||March 2014 (Final data collection date for primary outcome measure)|
Drug: Piperacillin-tazobactam combination product
4.5g q6h, 5-10 days
Other Name: Tazocin
|Active Comparator: imipenem/cilastatin||
0.5g q6h, 5-10 days
Other Name: Tienam
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01714570
|Chinese PLA general hospital|
|Beijing, Beijing, China, 100853|
|Principal Investigator:||wenrong huang, Doctor||Employee|