Prophylactic Piperacillin/Tazobactam in Hematopoietic Stem Cell Transplantation
Piperacillin/Tazobactam for Prophylaxis in Patients of Neutropenia After Hematopoietic Stem Cell Transplantation - A Pilot Study
1 other identifier
interventional
150
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2012
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 4, 2012
CompletedStudy Start
First participant enrolled
September 1, 2012
CompletedFirst Posted
Study publicly available on registry
October 26, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2014
CompletedOctober 26, 2012
October 1, 2012
2 years
July 4, 2012
October 25, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
febrile rate
In both group, how many patients developed febrile.
3 weeks after beginning of prophylaxis
Secondary Outcomes (4)
Microbiologic efficacy in febrile patients
3 weeks after beginning of prophylaxis
Recovery rate from neutropenia
3 weeks after beginning of prophylaxis
AE
3 weeks after beginning of prophylaxis
Cost of drug and hospital-stay
3 weeks after beginning of prophylaxis
Study Arms (3)
No prophylaxis
NO INTERVENTIONpiperacillin
ACTIVE COMPARATORpiperacillin/tazobactam
EXPERIMENTALInterventions
4.5g q8h 3-5 days
Eligibility Criteria
You may qualify if:
- Age 13-65 years
- Received Autologous or Allogeneic hematopoietic stem cell transplantation.
- ECOG score 0-1.
- ICF is available.
You may not qualify if:
- Allergic to any therapy drug.
- Documented infection before neutropenia.
- Renal dysfunction.
- Suffering from central nervous system or mental disease.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Chinese PLA general hospital
Beijing, Beijing Municipality, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
wenrong huang, Doctor
Employee
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate director, Hematology, Chinese PLA General hospital
Study Record Dates
First Submitted
July 4, 2012
First Posted
October 26, 2012
Study Start
September 1, 2012
Primary Completion
September 1, 2014
Study Completion
November 1, 2014
Last Updated
October 26, 2012
Record last verified: 2012-10