UMIN-CTR Clinical Trial

Basic information
Public title	Randomized clinical trial of antibiotic prophylaxis versus no intervention in muscle biopsy
Acronym	pros and cons antibiotic prophylaxis in muscle biopsy
Scientific Title	Randomized clinical trial of antibiotic prophylaxis versus no intervention in muscle biopsy
Scientific Title:Acronym	pros and cons antibiotic prophylaxis in muscle biopsy
Region	Japan

Condition
Condition	Patients with planning muscle biopsy
Classification by specialty	Neurology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this randomized clinical trial was to investigate whether or not a single intravenous dose of cefazolin (1g) should be performed to prevent wound infection for immunocompetent patients
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The incidence and proportion of wound infection after muscle biopsy
Key secondary outcomes	1) Background characteristics of patients 2) Adverse event of antibiotic 3) Wound score at the muscle biopsy performed region 4) characteristics of patients with wound infection 5) The relationship between days until the suture removal and the treatment with or without antibiotic 6) The relationship between body temperature and the treatment with or without antibiotic 7) The relationship between longitudinal changes of blood test (RBC, WBC, the subsets, PLT, Hb, BUN, Crea, TP, Alb, CK, AST, ALT, CRP) and the treatment with or without antibiotic 8) The relationship between longitudinal changes of blood test (RBC, WBC, the subsets, PLT, Hb, BUN, Crea, TP, Alb, CK, AST, ALT, CRP) and disease type, muscle biopsy performed region, operative duration of muscle biopsy and the value of manual muscle testing 9) The relationship between operative duration of muscle biopsy and disease type, muscle biopsy performed region, the value of manual muscle testing

Base
Study type	Interventional

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

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	The group with single-dose antibiotic prophylaxis of cefazolin (1g) at muscle biopsy.
Interventions/Control_2	The group without antibiotic prophylaxis at muscle biopsy
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	80 years-old >
Gender	Male and Female
Key inclusion criteria	1) Over 20 years old and less than 80 years old 2) Patient or proxy who can provide a informed consent
Key exclusion criteria	1) Patients who are not hospitalized in neurology 2) Less than 20 years old patients 3) Over 80 years old patients 4) Patients who are pregnant or might be pregnant 5) Immunocompromised patients 6) Patients with anamnesis of diabetes 7) Patients with over body mass index (BMI) of 25 kg/m2 8) Patients with experience of allergia for Cephalosporin antibiotic 9) Patients with anamnesis of anaphylactic shock for Cephalosporin 10) Patients with experience of hypersensitivity for local anesthetic such as anilide 11) Patients with over serum creatinine level 1.5 mg/dl 12) Patients with an infectious disease 13) Patient with treatment plan of immunosuppressive therapy immediately after muscle biopsy 14) Patients who have skin lesion at muscle biopsy planed region 15) Patients who are judged inappropriate for this trial by the attending physician
Target sample size	24

Research contact person
Name of lead principal investigator	1st name Satoshi Middle name Last name Yamashita
Organization	Graduate School of Medical Sciences, Kumamoto University
Division name	Department of Neurology
Zip code	860-8556
Address	1-1-1 Honjo Chuo-Ku, Kumamoto 860-8556, Japan
TEL	096-373-5893
Email	y-stsh@pg8.so-net.ne.jp

Public contact
Name of contact person	1st name Koutaro Middle name Last name Takamatsu
Organization	Graduate School of Medical Sciences, Kumamoto University
Division name	Department of Neurology
Zip code	860-8556
Address	1-1-1 Honjo Chuo-Ku, Kumamoto 860-8556, Japan
TEL	096-373-5893
Homepage URL
Email	takamakt@gmail.com

Sponsor
Institute	Kumamoto university
Institute
Department

Funding Source
Organization	self-financing
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Kumamoto University Hospital, Advanced medical care unit
Address	1-1-1 Honjo Chuo-Ku, Kumamoto 860-8556, Japan
Tel	096-373-5966
Email	byi-senshin@jimu.kumamoto-u.ac.jp

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 10 Month 18 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled	2
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Terminated
Date of protocol fixation	2018 Year 09 Month 27 Day
Date of IRB	2018 Year 09 Month 27 Day
Anticipated trial start date	2018 Year 11 Month 01 Day
Last follow-up date	2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 10 Month 17 Day
Last modified on	2021 Year 04 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000037479