UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Search of related factors with the hypoglycemia in use of the antibiotic containing pivoxyl group against infants
Title of the study (Brief title)	Antibiotic containing pivoxyl group and infants with hypoglycemia
Region	Japan

Condition
Condition	Hypoglycemia
Classification by specialty	Pediatrics Child
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The antibiotic containing pivoxyl group may cause hypoglycemia with hyper carnitinemia in long use of it. It is need for monitoring of it at the age from 0 to 5 years-old. This study investigates the transition of the urine and serum concentration of carnine and acyl-carnibitine and search of the useful factor for early prediction of hypoglycemia in use of antibiotic containing pivoxyl group.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	The urine and serum concentration of carnitine and acyl-carnitine, plasma glucose level, biochemical laboratory data.
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	0 years-old <=
Age-upper limit	5 years-old >=
Gender	Male and Female
Key inclusion criteria	The infant patient taking the antibiotic containing pivoxyl group
Key exclusion criteria	No
Target sample size

Research contact person
Name of lead principal investigator	Nariyasu Mano
Organization	Tohoku university hospital
Division name	Department of pharmaceutical sciences
Address	1-1 Seiryo-machi, Aoba-ku, Sendai
TEL	022-717-7525
Email	mano@hosp.tohoku.ac.jp

Public contact
Name of contact person	Masamitsu Maekawa
Organization	Tohoku university hospital
Division name	Department of pharmaceutical sciences
Address	1-1 Seiryo-machi, Aoba-ku, Sendai
TEL	022-717-7541
Homepage URL
Email	m-maekawa@hosp.tohoku.ac.jp

Sponsor
Institute	Department of pharmaceutical sciences, Tohoku university hospital
Institute
Department

Funding Source
Organization	Grant-in-Aid
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	Division of pediatrics, Tohoku university hospital
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	東北大学病院

Other administrative information
Date of disclosure of the study information	2015 Year 05 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 12 Month 15 Day
Anticipated trial start date	2014 Year 12 Month 25 Day
Last follow-up date	2016 Year 12 Month 31 Day
Date of closure to data entry	2016 Year 12 Month 31 Day
Date trial data considered complete	2016 Year 12 Month 31 Day
Date analysis concluded	2016 Year 12 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results	However a simultaneous analytical method for carnnitine metabolites and the antibiotic drug was developed, no samples from patients with adverse effects by antibiotics having pivoxyl group were recruited.
Other related information	The blood and urine concentration of carnitine and acyl-carnitine of patient with taking the antibiotic containing pivoxyl group are analyzed by LC/MS/MS and the factors related with adverse effect are searched.

Management information
Registered date	2015 Year 04 Month 30 Day
Last modified on	2017 Year 03 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000020128