A multicenter, randomized, controlled trial comparing the efficacy of oral fluoroquinolone and aminopenicillin with intravenous Cephalosporin in low-risk pediatric cancer patients with febrile neutropenia.
- Conditions
- Childhood cancer
- Registration Number
- JPRN-UMIN000006131
- Lead Sponsor
- Tokyo Metropolitan Children's Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 124
Not provided
1) patients who has a history of stem cell transplantation 2) acute leukemia or lymphoma patients who are under induction or consolidation chemotherapy 3) patients with suspected central venous catheter-related infection 4) patients with consciousness disturbance (under 15 points of pediatric Glasgow coma scale) 5) patients with hypotension 6) patients with hypoxemia (SpO2 less than 95% by pulse oximeter under the room air) 7) patients with apparent active infection 8) patients with nausea and vomiting expected difficult to take internal medicine 9) patients of organ failure (Grade3 or 4 level in NCI CTCAE, such as Hyperbilirubinemia,elevated alanine aminotransferase,elevated aspartate aminotransferase,elevated serum creatinine) 10) patients administrated other antibiotics (except sulfamethoxazole/trimethoprim as prophylaxis against pneumocystis carinii) 11) patients with hypersensitivity against Tosufloxacin, Amoxicillin/clavulanate,and cefepime 12) pregnant patients or those who are suspected pregnancy 13) patients who are considered inappropriate to join this study by the physicians
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method