Unique ID issued by UMIN | UMIN000006124 |
---|---|
Receipt number | R000007246 |
Scientific Title | Efficacy and safety of Doripenem (DRPM) versus Meropenem (MEPM) in patients with febrile neutropenia (FN); Multicenter open-label randomized controlled trial |
Date of disclosure of the study information | 2011/08/06 |
Last modified on | 2017/07/25 21:18:56 |
Efficacy and safety of Doripenem (DRPM) versus Meropenem (MEPM) in patients with febrile neutropenia (FN); Multicenter open-label randomized controlled trial
DRPM versus MEPM in patients with FN
Efficacy and safety of Doripenem (DRPM) versus Meropenem (MEPM) in patients with febrile neutropenia (FN); Multicenter open-label randomized controlled trial
DRPM versus MEPM in patients with FN
Japan |
febrile neutropenia
Medicine in general | Hematology and clinical oncology |
Malignancy
NO
A comparison between DRPM and MEPM for antibacterial treatment in patients with FN
Safety,Efficacy
Confirmatory
Pragmatic
Not applicable
Total clinical efficacy for 7days based on IDSA guideline
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
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
YES
NO
Institution is not considered as adjustment factor.
YES
Central registration
2
Treatment
Medicine |
Doripenem 1.0g every 8 hours by a 1-hour intravenous (IV) infusion
Meropenem 1.0g every 8 hours by IV infusion over 30minutes
16 | years-old | <= |
Not applicable |
Male and Female
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.
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.
120
1st name | |
Middle name | |
Last name | Yoji Ishida |
Iwate Medical University
Hematology/Oncology
Uchimaru 19-1, Morioka, Japan
+81-19-651-5111
yishida@iwate-med.ac.jp
1st name | |
Middle name | |
Last name | Tatsuo Oyake |
Iwate Medical University
Hematology/Oncology
Uchimaru 19-1, Morioka, Japan
+81-19-651-5111
toyake@iwate-med.ac.jp
Iwate Medical University
Iwate Medical University
Self funding
NO
岩手医科大学内科学講座血液腫瘍内科分野
2011 | Year | 08 | Month | 06 | Day |
Unpublished
Completed
2011 | Year | 05 | Month | 06 | Day |
2011 | Year | 08 | Month | 01 | Day |
2014 | Year | 12 | Month | 31 | Day |
2014 | Year | 12 | Month | 31 | Day |
2015 | Year | 12 | Month | 31 | Day |
2016 | Year | 01 | Month | 31 | Day |
2011 | Year | 08 | Month | 06 | Day |
2017 | Year | 07 | Month | 25 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007246
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |