UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Impact of neoplasm to vancomycin trough concentrations ~Preliminary investigation targeting the entire concentration range of vancomycin trough value~
Title of the study (Brief title)	Impact of neoplasm to vancomycin trough concentrations
Region	Japan

Condition
Condition	Infection with MRSA
Classification by specialty	Infectious disease
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Comparison of the Vancomycin trough value by the cancer species
Basic objectives2	Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	We compared the difference of the trough value by the cancer species
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	1 years-old <=
Age-upper limit	999 years-old >
Gender	Male and Female
Key inclusion criteria	To be written
Key exclusion criteria	To be written
Target sample size	78

Research contact person
Name of lead principal investigator	Shoko HASEGAWA
Organization	Shujitsu University
Division name	Faculty of Pharmacy
Address	1-6-1 Nishigawara, Naka-ku, Okayama,Japan
TEL	086-271-8409
Email	teshima@shujitu.ac.jp

Public contact
Name of contact person	Daisuke TESHIMA
Organization	Shujitsu University
Division name	Faculty of Pharmacy
Address	1-6-1 Nishigawara, Naka-ku, Okayama,Japan
TEL	086-271-8409
Homepage URL
Email	teshima@shujitu.ac.jp

Sponsor
Institute	Shujitsu University
Institute
Department

Funding Source
Organization	Self funding
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

Other administrative information
Date of disclosure of the study information	2018 Year 07 Month 15 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 04 Month 15 Day
Anticipated trial start date	2016 Year 04 Month 15 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	Published
URL releasing results
Results
Other related information	To be written

Management information
Registered date	2018 Year 07 Month 04 Day
Last modified on	2018 Year 07 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037721