UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effectiveness of de-escalation to cefmetazole for bacteremia. Open-label randomized non-inferiority trial
Title of the study (Brief title)	De-escalation to cefmetazole
Region	Japan

Condition
Condition	bacteremia
Classification by specialty	Infectious disease
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Cefmetazole, a cefamycin has activity against ESBL producing bacteria and preceding retrospective studies demonstrated its efficacy. It is a promising agent to spare carbapenems. However, there is no prospective studies to confirm its efficacy and safety. The current study examines the effectiveness of cefmetazole as an de-escalating agent for those with bacteremia diagnosed by blood cultures, comparing with those without de-escalation.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Mortality at 30 days after entry.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	de-escalation to cefmetazole 1g every 6-8 hours for about 10-14 days, depending on renal function of the patients.
Interventions/Control_2	Continues current treatment for about 10-14 days, depending on renal function of the patients.
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Bacteremic patients diagnosed by blood cultures, and those who were judged to be eligible for de-escalation to cefmetazole by infectious diseases doctors.
Key exclusion criteria	When the patient or the physician treating did not consent to the study participation. Those who had or are likely to have significant past history of cefmetazole side effects, such as anaphylaxis by beta-lactams.
Target sample size	184

Research contact person
Name of lead principal investigator	Kentaro Iwata
Organization	Kobe University
Division name	Division of Infectious Diseases
Address	Kusunokicho 7-5-2, Chuoku, Kobe
TEL	078-382-6297
Email	kentaroiwata1969@gmail.com

Public contact
Name of contact person	Toko Nakata
Organization	Kobe University
Division name	Division of Infectious Diseases
Address	Kusunokicho 7-5-2, Chuoku, Kobe
TEL	078-382-6297
Homepage URL
Email	kobeid@med.kobe-u.ac.jp

Sponsor
Institute	Kobe 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	2017 Year 07 Month 10 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 07 Month 10 Day
Anticipated trial start date	2017 Year 09 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	2017 Year 07 Month 10 Day
Last modified on	2017 Year 07 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032225