Efficacy and safety of Doripenem (DRPM) versus Meropenem (MEPM) in patients with febrile neutropenia (FN); Multicenter open-label randomized controlled trial
Not Applicable
- Conditions
- febrile neutropenia
- Registration Number
- JPRN-UMIN000006124
- Lead Sponsor
- Iwate Medical University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 120
Inclusion Criteria
Not provided
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Total clinical efficacy for 7days based on IDSA guideline
- Secondary Outcome Measures
Name Time Method 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