DRUG study (DRUG study)

Recruiting

• Conditions: Delayed drug allergy to Amoxicillin

• Registration Number: jRCT1040230121
• Lead Sponsor: Yasuoka Ryuhei

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-12-25
• Last Update Posted: 2023-12-25

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: Other
• Study Design: single assignment

Primary Outcome Measures

Name	Time	Method
Supernatant IFN-gamma Concentration of DLST by AMPC		Group differences in supernatant IFN-gamma concentration of drug lymphocyte stimulation test (DLST) by amoxicillin-clavulanic acid (AMPC) between children with delayed AMPC allergy and normal children

Secondary Outcome Measures

Name	Time	Method
Group Differences in Supernatant IL-2,IL-4,IL-5,IL-10,IL-12,IL-13,granzyme Concentration of DLST by AMPC		Group differences in supernatant cytokines (IL-2, IL-4, IL-5, IL-10, IL-12, IL-13, granzyme) of DLST by AMPC between 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		Difference in supernatant cytokines (IFN-gamma, IL-2, IL-4, IL-5, IL-10, IL-12, IL-13, granzyme) of DLST by AMPC between AMPC unstimulated (control) and AMPC stimulated samples in the AMPC delayed allergy group