A randomized,open labeled,prospective controlled study to assess of frontline empirical intravenous piperacillin/tazobactam monotherapy compared with ceftazidime plus amikacin for pediatric oncology patient with febrile neutropenia
Not Applicable
Recruiting
- Conditions
- To determine the efficacy and safety of pipercillin/tazobactam compared with ceftazidime plus amikacin in pediatric oncology patients with febrile neutropenia.pipercillin/tazobactampediatricfebrile neutropenia
- Registration Number
- TCTR20180205002
- Lead Sponsor
- Department of pediatrics, Faculty of medicine, Chiang Mai University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 118
Inclusion Criteria
-age < 18 years with diagnosis of malignancies
-fever : axillary tenperature 38.3 C or 38.0 C sustained over 1 hour
-neutropenia: ANC < 500 cell/mm3 or ANC <1000 cell/mm3 and expected to decrease to < 500 cell/mm3 during next 48 hours
Exclusion Criteria
-patients and/or parents decline to participate in this study
-systemic intravenous antibiotics pretreatment within 5 days before randomization
-history of hypersensitivity to any study drugs
-HIV infection
-Renal function impairment
-Fever due to blood component transfusion
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Early response to initial antibiotics at the end of treatment complete response to initial antibiotics and resolution of fever within 48 hours
- Secondary Outcome Measures
Name Time Method modification therapy at the end of treatment changes of antibiotics,side effects of drugs at the end of treatment records sides effect of drugs,morbidity and mortality at the end of treatment records morbidity and mortality ,costs of treatment at the end of treatment records cost of treatment ,blood stream infection and drug sensitivity at the end of treatment records blood stream infection and drug sensitivity