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Prophylactic Piperacillin/Tazobactam in Hematopoietic Stem Cell Transplantation

Primary Purpose

Neutropenia, Hematopoietic Stem Cell Transplantation

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Piperacillin
Piperacillin-tazobactam combination product
Sponsored by
Chinese PLA General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Neutropenia

Eligibility Criteria

13 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Chinese PLA general hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Active Comparator

Experimental

Arm Label

No prophylaxis

piperacillin

piperacillin/tazobactam

Arm Description

Outcomes

Primary Outcome Measures

febrile rate
In both group, how many patients developed febrile.

Secondary Outcome Measures

Microbiologic efficacy in febrile patients
The success rate and failure rate will be calculated. 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. 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
How many patients reached the ANC > 0.5×109/L more than 3 days.
AE
How many patients developed unexpected medical events.
Cost of drug and hospital-stay

Full Information

First Posted
July 4, 2012
Last Updated
October 25, 2012
Sponsor
Chinese PLA General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01714557
Brief Title
Prophylactic Piperacillin/Tazobactam in Hematopoietic Stem Cell Transplantation
Official Title
Piperacillin/Tazobactam for Prophylaxis in Patients of Neutropenia After Hematopoietic Stem Cell Transplantation - A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Unknown status
Study Start Date
September 2012 (undefined)
Primary Completion Date
September 2014 (Anticipated)
Study Completion Date
November 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese PLA General Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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: No prophylaxic antibiotic Piperacillin as prophylaxis for neutropenia patients. Piperacillin has anti-pseudomonas activity. Piperacillin/tazobactam as prophylaxis for neutropenia patients. Piperacillin/tazobactam has highest susceptibility rate among common anti-pseudomonas antibiotics.
Detailed Description
Swab culture (skin, pharyngeal, nasal, anus) when administered into laminar flow room after transplantation. Randomize the neutropenia patients into 3 groups. Receive 3 regimen. Full record of clinical data, including background diseases, previous antibiotics within 90 days, febrile or not at the TOC. For patients developed febrile, imipenem will be prescribed, even if the patient received no prophylaxis. At the same time, the follow-up ended.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neutropenia, Hematopoietic Stem Cell Transplantation

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
No prophylaxis
Arm Type
No Intervention
Arm Title
piperacillin
Arm Type
Active Comparator
Arm Title
piperacillin/tazobactam
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Piperacillin
Intervention Description
4.0g q8h 3-5 days
Intervention Type
Drug
Intervention Name(s)
Piperacillin-tazobactam combination product
Other Intervention Name(s)
Tazocin
Intervention Description
4.5g q8h 3-5 days
Primary Outcome Measure Information:
Title
febrile rate
Description
In both group, how many patients developed febrile.
Time Frame
3 weeks after beginning of prophylaxis
Secondary Outcome Measure Information:
Title
Microbiologic efficacy in febrile patients
Description
The success rate and failure rate will be calculated. 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. 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.
Time Frame
3 weeks after beginning of prophylaxis
Title
Recovery rate from neutropenia
Description
How many patients reached the ANC > 0.5×109/L more than 3 days.
Time Frame
3 weeks after beginning of prophylaxis
Title
AE
Description
How many patients developed unexpected medical events.
Time Frame
3 weeks after beginning of prophylaxis
Title
Cost of drug and hospital-stay
Time Frame
3 weeks after beginning of prophylaxis

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
wenrong huang, Doctor
Organizational Affiliation
Employee
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chinese PLA general hospital
City
Beijing
State/Province
Beijing
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wenrong Huang, Doctor
Email
huangwr301@yahoo.com.cn

12. IPD Sharing Statement

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Prophylactic Piperacillin/Tazobactam in Hematopoietic Stem Cell Transplantation

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