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Piperacillin/Tazobactam for Empirical Therapy of Febrile Neutropenia

Information source: Chinese PLA General Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Febrile; Neutropenia; Hematopoietic Stem Cell Transplantation

Intervention: Piperacillin-tazobactam combination product (Drug); Imipenem (Drug)

Phase: N/A

Status: Completed

Sponsored by: Chinese PLA General Hospital

Official(s) and/or principal investigator(s):
wenrong huang, Doctor, Principal Investigator, Affiliation: Employee


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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Clinical success rate.

Secondary outcome:

Microbiologic success rate

Adverse effect

Cost of drug and therapy

Detailed description: 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.


Minimum age: 13 Years. Maximum age: 65 Years. Gender(s): Both.


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.

Locations and Contacts

Chinese PLA general hospital, Beijing, Beijing 100853, China
Additional Information

Starting date: November 2012
Last updated: April 16, 2014

Page last updated: August 23, 2015

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