UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy and safety of Doripenem (DRPM) versus Meropenem (MEPM) in patients with febrile neutropenia (FN); Multicenter open-label randomized controlled trial
Title of the study (Brief title)	DRPM versus MEPM in patients with FN
Region	Japan

Condition
Condition	febrile neutropenia
Classification by specialty	Medicine in general Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	A comparison between DRPM and MEPM for antibacterial treatment in patients with FN
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Total clinical efficacy for 7days based on IDSA guideline
Key secondary outcomes	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

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Doripenem 1.0g every 8 hours by a 1-hour intravenous (IV) infusion
Interventions/Control_2	Meropenem 1.0g every 8 hours by IV infusion over 30minutes
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	16 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key 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.
Key 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.
Target sample size	120

Research contact person
Name of lead principal investigator	Yoji Ishida
Organization	Iwate Medical University
Division name	Hematology/Oncology
Address	Uchimaru 19-1, Morioka, Japan
TEL	+81-19-651-5111
Email	yishida@iwate-med.ac.jp

Public contact
Name of contact person	Tatsuo Oyake
Organization	Iwate Medical University
Division name	Hematology/Oncology
Address	Uchimaru 19-1, Morioka, Japan
TEL	+81-19-651-5111
Homepage URL
Email	toyake@iwate-med.ac.jp

Sponsor
Institute	Iwate Medical University
Institute
Department

Funding Source
Organization	Iwate Medical University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	岩手医科大学内科学講座血液腫瘍内科分野

Other administrative information
Date of disclosure of the study information	2011 Year 08 Month 06 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 05 Month 06 Day
Anticipated trial start date	2011 Year 08 Month 01 Day
Last follow-up date	2014 Year 12 Month 31 Day
Date of closure to data entry	2014 Year 12 Month 31 Day
Date trial data considered complete	2015 Year 12 Month 31 Day
Date analysis concluded	2016 Year 01 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2011 Year 08 Month 06 Day
Last modified on	2017 Year 07 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000007246