Prophylactic Piperacillin/Tazobactam in Hematopoietic Stem Cell Transplantation

October 25, 2012 updated by: Wenrong Huang, Chinese PLA General Hospital

Piperacillin/Tazobactam for Prophylaxis in Patients of Neutropenia After Hematopoietic Stem Cell Transplantation - A Pilot Study

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: No prophylaxis
Active Comparator: piperacillin
Drug: Piperacillin
4.0g q8h 3-5 days
Experimental: piperacillin/tazobactam
Drug: Piperacillin-tazobactam combination product
4.5g q8h 3-5 days
Other Names:
  • Tazocin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
febrile rate
Time Frame: 3 weeks after beginning of prophylaxis
In both group, how many patients developed febrile.
3 weeks after beginning of prophylaxis

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Microbiologic efficacy in febrile patients
Time Frame: 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.
3 weeks after beginning of prophylaxis
Recovery rate from neutropenia
Time Frame: 3 weeks after beginning of prophylaxis
How many patients reached the ANC > 0.5×109/L more than 3 days.
3 weeks after beginning of prophylaxis
AE
Time Frame: 3 weeks after beginning of prophylaxis
How many patients developed unexpected medical events.
3 weeks after beginning of prophylaxis
Cost of drug and hospital-stay
Time Frame: 3 weeks after beginning of prophylaxis
3 weeks after beginning of prophylaxis

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese PLA General Hospital

Investigators

  • Principal Investigator: wenrong huang, Doctor, Employee

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Anticipated)

September 1, 2014

Study Completion (Anticipated)

November 1, 2014

Study Registration Dates

First Submitted

July 4, 2012

First Submitted That Met QC Criteria

October 25, 2012

First Posted (Estimate)

October 26, 2012

Study Record Updates

Last Update Posted (Estimate)

October 26, 2012

Last Update Submitted That Met QC Criteria

October 25, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TZP-HEM-20120608

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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