febrile neutropenia
Conditions
Interventions
Doripenem 1.0g every 8 hours by a 1-hour intravenous (IV) infusion
Meropenem 1.0g every 8 hours by IV infusion over 30minutes
Sponsors
Iwate Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients with acute leukemia, chronic myeloid leukemia (CML) in blast crisis (BC) and myelodysplatic syndrome (MDS) aged >=16 years, which have chemotherapy, were eligible to be participated if they had an absolute neutrophil count < 500/ uL for and fever (38 degrees C). 2) After obtaining signed informed consent.
Exclusion criteria
Exclusion criteria: 1) Isolated pathogen not sensitive to DRPM or MEPM. 2) Severe cardiac, hepatic or renal dysfunction. 3) History of allergy or hypersensitivity to beta-lactam antibiotics. 4) History of very severe allergy or hypersensitivity to another drugs or foods. 5) Not evaluable patients for the cause of aging factors 6) Pediatric patients (<16 years). 7) Not eligible patients by the physician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total clinical efficacy for 7days based on IDSA guideline | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy assessed by 1) Resolution of fever in 3-5 days after administration, 2) Resolution rate of fever for 14 days after administration, 3) Survival for 30 days after administration and 4) Bacteriological effect Safety assessed by 1) Monitoring of clinical laboratory data and 2) Incidence of drug-related adverse events | — |
Countries
Japan
Contacts
Public ContactTatsuo Oyake
Iwate Medical University Hematology/Oncology
Outcome results
None listed