Febrile, Neutropenia, Hematopoietic Stem Cell Transplantation
Conditions
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
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.
Interventions
4.5g q6h, 5-10 days
DRUGImipenem
0.5g q6h, 5-10 days
Sponsors
Chinese PLA General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
13 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical success rate. | 3 weeks after beginning of empirical therapy | Resolve of clinical symptoms and signs, without change of therapy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Microbiologic success rate | 3 weeks after beginning of empirical therapy | Microbiologic success includes eradication, suspected eradication, and super-infection. 1. 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 2. No eradication: one or more baseline pathogens were persistent 3. Relapse: the baseline pathogens transient absence reappeared during the therapy 4. Alternative: the baseline pathogens were eradicated, but new ones appeared without any clinical signs and symptoms 5. Re-infection: the baseline pathogens were eradicated, but new ones appeared with clinical signs and symptoms. |
| Adverse effect | 3 weeks after beginning of empirical therapy | The number of patients developed unexpected medical information at the 3 weeks after beginning of empirical therapy. |
| Cost of drug and therapy | 3 weeks after beginning of empirical therapy | — |
Countries
China
Outcome results
None listed