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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 123
- Locations
- 1
- Primary Endpoint
- Clinical success rate.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 13 Years to 65 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age 13-65 years
- •received Autologous or Allogeneic hematopoietic stem cell transplantation.
- •ECOG score 0-
- •ICF is available.
Exclusion Criteria
- •Allergic to any therapy drug.
- •Documented infection before neutropenia.
- •Renal dysfunction.
- •Suffering from central nervous system or mental disease.
Arms & Interventions
piperacillin/tazobactam
Intervention: Piperacillin-tazobactam combination product (Drug)
imipenem/cilastatin
Intervention: Imipenem (Drug)
Outcomes
Primary Outcomes
Clinical success rate.
Time Frame: 3 weeks after beginning of empirical therapy
Resolve of clinical symptoms and signs, without change of therapy.
Secondary Outcomes
- Microbiologic success rate(3 weeks after beginning of empirical therapy)
- Adverse effect(3 weeks after beginning of empirical therapy)
- Cost of drug and therapy(3 weeks after beginning of empirical therapy)
Investigators
Wenrong Huang
Associate director, Hematology, Chinese PLA General hospital
Chinese PLA General Hospital