Piperacillin/Tazobactam for Empirical Therapy of Febrile Neutropenia
Information source: Chinese PLA General Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Febrile; Neutropenia; Hematopoietic Stem Cell Transplantation
Intervention: Piperacillin-tazobactam combination product (Drug); Imipenem (Drug)
Phase: N/A
Status: Completed
Sponsored by: Chinese PLA General Hospital Official(s) and/or principal investigator(s):
wenrong huang, Doctor, Principal Investigator, Affiliation: Employee
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.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Clinical success rate.
Secondary outcome: Microbiologic success rateAdverse effect Cost of drug and therapy
Detailed description:
1. Swab culture (skin, pharyngeal, nasal, anus) when administered into laminar flow room
after transplantation.
2. Randomize the febrile patients into 2 groups.
3. Therapy group receive piperacillin/tazobactam, 4. 5g q6h iv. Control group receive
imipenem/cilastatin, 0. 5g q6h. Duration will be 5-10 days.
Eligibility
Minimum age: 13 Years.
Maximum age: 65 Years.
Gender(s): Both.
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.
Locations and Contacts
Chinese PLA general hospital, Beijing, Beijing 100853, China
Additional Information
Starting date: November 2012
Last updated: April 16, 2014
|
