Back to resultsPiperacillin/Tazobactam for Empirical Therapy of Febrile Neutropenia
Primary Purpose
Febrile, Neutropenia, Hematopoietic Stem Cell Transplantation
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Piperacillin-tazobactam combination product
Imipenem
Sponsored by
About this trial
This is an interventional treatment trial for Febrile
Eligibility 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.
Sites / Locations
- Chinese PLA general hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
piperacillin/tazobactam
imipenem/cilastatin
Arm Description
Outcomes
Primary Outcome Measures
Clinical success rate.
Resolve of clinical symptoms and signs, without change of therapy.
Secondary Outcome Measures
Microbiologic success rate
Microbiologic success includes eradication, suspected eradication, and super-infection.
Eradication or Presumed eradication: the baseline pathogens no longer present on the culture performed after completion of treatment. If no way to collect biologic sample(s) after treatment;, e.g. sputum, a presumed eradication will be concluded
No eradication: one or more baseline pathogens were persistent
Relapse: the baseline pathogens transient absence reappeared during the therapy
Alternative: the baseline pathogens were eradicated, but new ones appeared without any clinical signs and symptoms
Re-infection: the baseline pathogens were eradicated, but new ones appeared with clinical signs and symptoms.
Adverse effect
The number of patients developed unexpected medical information at the 3 weeks after beginning of empirical therapy.
Cost of drug and therapy
Full Information
NCT ID
NCT01714570
First Posted
July 4, 2012
Last Updated
April 16, 2014
Sponsor
Chinese PLA General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01714570
Brief Title
Piperacillin/Tazobactam for Empirical Therapy of Febrile Neutropenia
Official Title
A Prospective, Randomized, Open Label Study of Piperacillin/Tazobactam Versus Imipenem/Cilastin for Empirical Therapy of Febrile Patients With Neutropenia After Hematopoietic Stem Cell Transplantation
Study Type
Interventional
2. Study Status
Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
April 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese PLA General Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Neutropenia is very common in patients received hematopoietic stem cell transplantation, with median duration of about 14 days. In 2010 update, IDSA recommended Piperacillin/tazobactam as first-line mono-therapy for febrile patients with neutropenia of high risk. In china, the data of piperacillin/tazobactam for febrile neutropenia after hematopoietic stem cell transplantation is very limited.
The current study will evaluate the efficacy of piperacillin/tazobactam compared with imipenem/cilastatin for febrile neutropenia after transplantation.
Detailed Description
Swab culture (skin, pharyngeal, nasal, anus) when administered into laminar flow room after transplantation.
Randomize the febrile patients into 2 groups.
Therapy group receive piperacillin/tazobactam, 4.5g q6h iv. Control group receive imipenem/cilastatin, 0.5g q6h. Duration will be 5-10 days.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Febrile, Neutropenia, Hematopoietic Stem Cell Transplantation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
123 (Actual)
8. Arms, Groups, and Interventions
Arm Title
piperacillin/tazobactam
Arm Type
Experimental
Arm Title
imipenem/cilastatin
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Piperacillin-tazobactam combination product
Other Intervention Name(s)
Tazocin
Intervention Description
4.5g q6h, 5-10 days
Intervention Type
Drug
Intervention Name(s)
Imipenem
Other Intervention Name(s)
Tienam
Intervention Description
0.5g q6h, 5-10 days
Primary Outcome Measure Information:
Title
Clinical success rate.
Description
Resolve of clinical symptoms and signs, without change of therapy.
Time Frame
3 weeks after beginning of empirical therapy
Secondary Outcome Measure Information:
Title
Microbiologic success rate
Description
Microbiologic success includes eradication, suspected eradication, and super-infection.
Eradication or Presumed eradication: the baseline pathogens no longer present on the culture performed after completion of treatment. If no way to collect biologic sample(s) after treatment;, e.g. sputum, a presumed eradication will be concluded
No eradication: one or more baseline pathogens were persistent
Relapse: the baseline pathogens transient absence reappeared during the therapy
Alternative: the baseline pathogens were eradicated, but new ones appeared without any clinical signs and symptoms
Re-infection: the baseline pathogens were eradicated, but new ones appeared with clinical signs and symptoms.
Time Frame
3 weeks after beginning of empirical therapy
Title
Adverse effect
Description
The number of patients developed unexpected medical information at the 3 weeks after beginning of empirical therapy.
Time Frame
3 weeks after beginning of empirical therapy
Title
Cost of drug and therapy
Time Frame
3 weeks after beginning of empirical therapy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
wenrong huang, Doctor
Organizational Affiliation
Employee
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chinese PLA general hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100853
Country
China
12. IPD Sharing Statement
Learn more about this trial
Piperacillin/Tazobactam for Empirical Therapy of Febrile Neutropenia
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