Prophylactic Piperacillin/Tazobactam in Hematopoietic Stem Cell Transplantation

Not Applicable

• Conditions: Neutropenia; Hematopoietic Stem Cell Transplantation
• Interventions: Drug: Piperacillin; Drug: Piperacillin-tazobactam combination product

• Registration Number: NCT01714557
• Lead Sponsor: Chinese PLA General Hospital

Brief 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.

Detailed 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 Timeline

• Study First Submitted: 2012-07-04
• Study Start: 2012-09
• Status Verified: 2012-10
• Study First Submitted QC: 2012-10-25
• Last Update Submitted: 2012-10-25
• Study First Posted: 2012-10-26
• Last Update Posted: 2012-10-26
• Primary Completion: 2014-09
• Study Completion: 2014-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Age 13-65 years
• Received Autologous or Allogeneic hematopoietic stem cell transplantation.
• ECOG score 0-1.
• ICF is available.

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Exclusion Criteria

• Allergic to any therapy drug.
• Documented infection before neutropenia.
• Renal dysfunction.
• Suffering from central nervous system or mental disease.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
piperacillin	Piperacillin	-
piperacillin/tazobactam	Piperacillin-tazobactam combination product	-

Primary Outcome Measures

Name	Time	Method
febrile rate	3 weeks after beginning of prophylaxis	In both group, how many patients developed febrile.

Secondary Outcome Measures

Name	Time	Method
Microbiologic efficacy in febrile patients	3 weeks after beginning of prophylaxis	The success rate and failure rate will be calculated.; 1. The microbiologic culture is positive at 3 weeks of prophylaxis, showing pathogen sensitive to Piperacillin/tazobactam, the case will be evaluated as breakthrough infection, that means microbiologic failure.; 2. The microbiologic culture is negative at 3 weeks of prophylaxis,, or positive fungus or non-typical organisms, the case will be evaluated as microbiologic success.
Recovery rate from neutropenia	3 weeks after beginning of prophylaxis	How many patients reached the ANC \> 0.5×109/L more than 3 days.
AE	3 weeks after beginning of prophylaxis	How many patients developed unexpected medical events.
Cost of drug and hospital-stay	3 weeks after beginning of prophylaxis

Trial Locations

Locations (1)

Chinese PLA general hospital; 🇨🇳 Beijing, Beijing, China