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Prophylactic Piperacillin/Tazobactam in Hematopoietic Stem Cell Transplantation

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ClinicalTrials.gov Identifier: NCT01714557
Recruitment Status : Unknown
Verified October 2012 by Wenrong Huang, Chinese PLA General Hospital.
Recruitment status was:  Not yet recruiting
First Posted : October 26, 2012
Last Update Posted : October 26, 2012
Information provided by (Responsible Party):
Wenrong Huang, 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.

Condition or disease Intervention/treatment Phase
Neutropenia Hematopoietic Stem Cell Transplantation Drug: Piperacillin Drug: Piperacillin-tazobactam combination product Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Piperacillin/Tazobactam for Prophylaxis in Patients of Neutropenia After Hematopoietic Stem Cell Transplantation - A Pilot Study
Study Start Date : September 2012
Estimated Primary Completion Date : September 2014
Estimated Study Completion Date : November 2014

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 Name: Tazocin

Primary Outcome Measures :
  1. febrile rate [ Time Frame: 3 weeks after beginning of prophylaxis ]
    In both group, how many patients developed febrile.

Secondary Outcome Measures :
  1. 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.

  2. 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. AE [ Time Frame: 3 weeks after beginning of prophylaxis ]
    How many patients developed unexpected medical events.

  4. Cost of drug and hospital-stay [ Time Frame: 3 weeks after beginning of prophylaxis ]

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Ages Eligible for Study:   13 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01714557

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China, Beijing
Chinese PLA general hospital
Beijing, Beijing, China
Contact: Wenrong Huang, Doctor       huangwr301@yahoo.com.cn   
Sponsors and Collaborators
Chinese PLA General Hospital
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Principal Investigator: wenrong huang, Doctor Employee
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Responsible Party: Wenrong Huang, Associate director, Hematology, Chinese PLA General hospital, Chinese PLA General Hospital
ClinicalTrials.gov Identifier: NCT01714557    
Other Study ID Numbers: TZP-HEM-20120608
First Posted: October 26, 2012    Key Record Dates
Last Update Posted: October 26, 2012
Last Verified: October 2012
Additional relevant MeSH terms:
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Leukocyte Disorders
Hematologic Diseases
Piperacillin, Tazobactam Drug Combination
Anti-Bacterial Agents
Anti-Infective Agents
beta-Lactamase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action