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Clinical Trial Summary

Neutropenia is very common in patients received hematopoietic stem cell transplantation, with median duration of about 14 days. Almost all neutropenia will suffer from febrile without prophylactic antibiotics. IDSA recommended fluoroquinolones as prophylaxis in neutropenia patients of high risks, while in China, major pathogens possess high resistance to fluoroquinolones. It is not clear whether prophylaxis is of benefit, nor the appropriate prophylaxis regimen.

The current study will evaluate the three different regimen:

1. No prophylaxic antibiotic

2. Piperacillin as prophylaxis for neutropenia patients. Piperacillin has anti-pseudomonas activity.

3. Piperacillin/tazobactam as prophylaxis for neutropenia patients. Piperacillin/tazobactam has highest susceptibility rate among common anti-pseudomonas antibiotics.


Clinical Trial Description

1. Swab culture (skin, pharyngeal, nasal, anus) when administered into laminar flow room after transplantation.

2. Randomize the neutropenia patients into 3 groups.

3. Receive 3 regimen.

4. Full record of clinical data, including background diseases, previous antibiotics within 90 days, febrile or not at the TOC.

5. For patients developed febrile, imipenem will be prescribed, even if the patient received no prophylaxis. At the same time, the follow-up ended. ;


Study Design

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


Related Conditions & MeSH terms


NCT number NCT01714557
Study type Interventional
Source Chinese PLA General Hospital
Contact
Status Not yet recruiting
Phase N/A
Start date September 2012
Completion date November 2014

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