Piperacillin/Tazobactam for Empirical Therapy of Febrile Neutropenia

Chinese PLA General Hospital (301 Hospital)

Status: Completed

Conditions: Neutropenia; Febrile; Hematopoietic Stem Cell Transplantation

Treatments: Drug: Piperacillin-tazobactam combination product; Drug: Imipenem

Study type: Interventional

Funder types: Other

Identifiers

NCT01714570

PTZ-20120702

Details and patient eligibility

About

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.

Full 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.

Enrollment: 123 patients

Sex: All

Ages: 13 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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123 participants in 2 patient groups

piperacillin/tazobactam

Experimental group

Treatment:

Drug: Piperacillin-tazobactam combination product

imipenem/cilastatin

Active Comparator group

Treatment:

Drug: Imipenem