We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Prophylactic Piperacillin/Tazobactam in Hematopoietic Stem Cell Transplantation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Information provided by (Responsible Party):
Wenrong Huang, Chinese PLA General Hospital

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
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

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   13 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Locations
Layout table for location information
China, Beijing
Chinese PLA general hospital
Beijing, Beijing, China
Contact: Wenrong Huang, Doctor       huangwr301@yahoo.com.cn   
Sponsors and Collaborators
Chinese PLA General Hospital
Investigators
Layout table for investigator information
Principal Investigator: wenrong huang, Doctor Employee
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
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:
Layout table for MeSH terms
Neutropenia
Agranulocytosis
Leukopenia
Leukocyte Disorders
Hematologic Diseases
Tazobactam
Piperacillin
 Piperacillin, Tazobactam Drug Combination
Anti-Bacterial Agents
Anti-Infective Agents
beta-Lactamase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action