臨床研究等提出・公開システム

Japanese

Date of registration	Dec. 25, 2023
Last modified on	Dec. 25, 2023
Trial ID	jRCT1040230121

Scientific Title	new Diagnostic method Research for delayed drug allergy caused by amoxicillin Using druG-stimulated lymphocytes (DRUG study)
Public Title	DRUG study (DRUG study)

Contact for Scientific Queries	Name	Yasuoka Ryuhei
	Affiliation	Hamamatsu University School of Medicine
	Address	1-20-1, Handayama, Higashi-ku, Hamamatsu City , 431- 3192 Japan
	Telephone	+81-53-435-2312
	E-mail	ysok@hama-med.ac.jp
Contact for Public Queries	Name	Yasuoka Ryuhei
	Affiliation	Hamamatsu University School of Medicine
	Address	1-20-1, Handayama, Higashi-ku, Hamamatsu City , 431- 3192 Japan
	Telephone	+81-53-435-2312
	E-mail	ysok@hama-med.ac.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		Dec. 25, 2023
Actual date of first enrollment
Target sample size		30
Study Type		Other
Study Design	allocation	non-randomized controlled trial
	masking	open(masking not used)
	control	placebo control
	assignment	single assignment
	purpose	screening
Key inclusion & exclusion criteria	Inclusion Criteria	1.Patients aged younger than 15 years old at recruitment 2.Patients who developed a skin rash during or within 48 hours of the end of use of AMPC/ABPC or antimicrobial agents containing AMPC/ABPC 3.Patients with a confirmed diagnosis of AMPC delayed hypersensitivity reaction 4.Patients with a history of delayed hypersensitivity reactions within 90 days of symptom induction 5.Patients whose caregivers agreed to participate in this study in writing
	Exclusion Criteria	1. Patients with severe delayed hypersensitivity reactions 2. Patients who have received systemic administration of steroids within a week 3. Patients with concomitant immune-related diseases 4. Patients with concomitant diseases that may affect the proteome and metabolome, such as metabolic diseases.
	Age Minimum	No limit
	Age Maximum	15age old not
	Gender	Both
Health Condition(s) or Problem(s) Studied		Delayed drug allergy to Amoxicillin
Intervention(s)
Health Condition(s) Keyword		Delayed drug allergy
Intervention(s) Keyword
Health Condition(s) Code		D004342
Intervention(s) Code
Primary Outcome(s)		Group Differences in Supernatant IFN-gamma Concentration of DLST by AMPC in Children with Delayed AMPC Allergy and Normal Children
Secondary Outcome(s)		Group Differences in Supernatant IL-2,IL-4,IL-5,IL-10,IL-12,IL-13,granzyme Concentration of DLST by AMPC in Children with Delayed AMPC Allergy and Normal Children Difference in supernatant cytokines (IFN-gamma,IL-2,IL-4,IL-5,IL-10,IL-12,IL-13,granzyme) of DLST by AMPC in the AMPC delayed allergy group between AMPC unstimulated (control) and AMPC stimulated samples.

Primary Sponsor	Yasuoka Ryuhei

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support	Hamamatsu University School of Medicine FY2023 Intramural Research Project (Support Project for Young Researchers)
Secondary Sponsor	Not applicable

Name of Certified Review Board	Ethics Committee of Hamamatsu University School of Medicine
Address	1-20-1, Handayama, Higashi-ku, Hamamatsu City , 431- 3192 Japan, Shizuoka, Shizuoka
Telephone	+81-53-435-2111
E-Mail	rinri@hama-med.ac.jp
Approval Status	Approval
Date of approval	June. 28, 2023

Plan to share IPD	No
Plan description

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none