UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy and safety of Garenoxacin for the prevention in the patients with hematological malignancies after chemotherapy
Title of the study (Brief title)	Garenoxacin for the prevention in hematological malignancies
Region	Japan

Condition
Condition	hematological malignancies
Classification by specialty	Hematology and clinical oncology Infectious disease
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	We aim to evaluate the effect and safety of Garenoxacin for prevention in the patients with hematological malignancies after chemotherapy
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	Frequencies of feblile neutropenia
Key secondary outcomes	Frequencies of adverse events

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Medicine
Interventions/Control_1	Garenoxacin for prevention
Interventions/Control_2
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)Hematological malignancies 2)Neutropenia is expected to continue for one week or more 3)Written informed consent was obtained from each patient before enrollment in the study 4)Patient who was judged that prophylaxis is necessary
Key exclusion criteria	1)GRNX is obviously ineffective to the pathogen. 2)Patients with a history of allergy/severe adverse effect to quinolone antibacterial agents or garenoxacin 3)Allergic diathesis 4)Pregnancy/lactation 5)Age of 15 years or younger 6)Patient was received systemic antibacterial therapy within 14 days 7)Patients who are regarded as inadequate
Target sample size	50

Research contact person
Name of lead principal investigator	Hisashi Tsurumi
Organization	Gifu University Hospital
Division name	First Department of Internal Medicine
Address	1-1 Yanagido Gifu
TEL	058-230-6000
Email	htsuru@gifu-u.ac.jp

Public contact
Name of contact person	Hisashi Tsurumi
Organization	Gifu University Hospital
Division name	First Department of Internal Medicine
Address	1-1 Yanagido Gifu
TEL	058-230-6000
Homepage URL
Email	htsuru@gifu-u.aco.jp

Sponsor
Institute	Gifu University Hospital
Institute
Department

Funding Source
Organization	Gifu University Hospital
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Japan

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

Other administrative information
Date of disclosure of the study information	2011 Year 01 Month 31 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2010 Year 11 Month 10 Day
Anticipated trial start date	2011 Year 02 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

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

Management information
Registered date	2011 Year 01 Month 30 Day
Last modified on	2016 Year 11 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000005733