Prophylactic Piperacillin/Tazobactam in Hematopoietic Stem Cell Transplantation
NCT ID: NCT01714557
Last Updated: 2012-10-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
150 participants
INTERVENTIONAL
2012-09-30
2014-11-30
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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No prophylaxis
No interventions assigned to this group
piperacillin
Piperacillin
4.0g q8h 3-5 days
piperacillin/tazobactam
Piperacillin-tazobactam combination product
4.5g q8h 3-5 days
Interventions
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Piperacillin
4.0g q8h 3-5 days
Piperacillin-tazobactam combination product
4.5g q8h 3-5 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Received Autologous or Allogeneic hematopoietic stem cell transplantation.
* ECOG score 0-1.
* ICF is available.
Exclusion Criteria
* Documented infection before neutropenia.
* Renal dysfunction.
* Suffering from central nervous system or mental disease.
13 Years
65 Years
ALL
No
Sponsors
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Chinese PLA General Hospital
OTHER
Responsible Party
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Wenrong Huang
Associate director, Hematology, Chinese PLA General hospital
Principal Investigators
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wenrong huang, Doctor
Role: PRINCIPAL_INVESTIGATOR
Employee
Locations
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Chinese PLA general hospital
Beijing, Beijing Municipality, China
Countries
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Facility Contacts
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Wenrong Huang, Doctor
Role: primary
Other Identifiers
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TZP-HEM-20120608
Identifier Type: -
Identifier Source: org_study_id