NCT01714570

Piperacillin/Tazobactam for Empirical Therapy of Febrile Neutropenia

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 123 (actual)
• Sponsor: Chinese PLA General Hospital · Academic / Other
• Sex: All
• Age: 13 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Febrile
• Neutropenia
• Hematopoietic Stem Cell Transplantation

Interventions

Type	Name	Description
DRUG	Piperacillin-tazobactam combination product	4.5g q6h, 5-10 days
DRUG	Imipenem	0.5g q6h, 5-10 days

Timeline

• Start date: 2012-11-01
• Primary completion: 2014-03-01
• Completion: 2014-04-01
• First posted: 2012-10-26
• Last updated: 2014-04-17

Locations

1 site across 1 country: China