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Prophylactic Piperacillin/Tazobactam in Hematopoietic Stem Cell Transplantation

This study is not yet open for participant recruitment.
Verified October 2012 by Chinese PLA General Hospital
Sponsor:
Information provided by (Responsible Party):
Wenrong Huang, Chinese PLA General Hospital
ClinicalTrials.gov Identifier:
NCT01714557
First received: July 4, 2012
Last updated: October 25, 2012
Last verified: October 2012
History of Changes
  Purpose

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 Intervention
Neutropenia
Hematopoietic Stem Cell Transplantation
 Drug: Piperacillin
Drug: Piperacillin-tazobactam combination product

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Piperacillin/Tazobactam for Prophylaxis in Patients of Neutropenia After Hematopoietic Stem Cell Transplantation - A Pilot Study

Resource links provided by NLM:

MedlinePlus related topics: Antibiotics Fever
U.S. FDA Resources

Further study details as provided by Chinese PLA General Hospital:

Primary Outcome Measures:
  • febrile rate [ Time Frame: 3 weeks after beginning of prophylaxis ] [ Designated as safety issue: Yes ]
    In both group, how many patients developed febrile.


Secondary Outcome Measures:
  • Microbiologic efficacy in febrile patients [ Time Frame: 3 weeks after beginning of prophylaxis ] [ Designated as safety issue: No ]

    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 [ Time Frame: 3 weeks after beginning of prophylaxis ] [ Designated as safety issue: No ]
    How many patients reached the ANC > 0.5×109/L more than 3 days.

  • AE [ Time Frame: 3 weeks after beginning of prophylaxis ] [ Designated as safety issue: Yes ]
    How many patients developed unexpected medical events.

  • Cost of drug and hospital-stay [ Time Frame: 3 weeks after beginning of prophylaxis ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: September 2012
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   13 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01714557

Locations
China, Beijing
Chinese PLA general hospital Not yet recruiting
Beijing, Beijing, China
Contact: Wenrong Huang, Doctor         huangwr301@yahoo.com.cn    
Sponsors and Collaborators
Chinese PLA General Hospital
Investigators
Principal Investigator: wenrong huang, Doctor Employee
  More Information

No publications provided

Responsible Party: Wenrong Huang, Associate director, Hematology, Chinese PLA General hospital, Chinese PLA General Hospital
ClinicalTrials.gov Identifier: NCT01714557     History of Changes
Other Study ID Numbers: TZP-HEM-20120608
Study First Received: July 4, 2012
Last Updated: October 25, 2012
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Neutropenia
Agranulocytosis
Leukopenia
Leukocyte Disorders
Hematologic Diseases
Piperacillin
Penicillanic Acid
Piperacillin-tazobactam combination product
 Tazobactam
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 22, 2013