DRUG study

JRCT ID: jRCT1040230121

Registered date:25/12/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Delayed drug allergy to Amoxicillin
• Date of first enrollment: 25/12/2023
• Target sample size: 30
• Study type: Other

Outcome(s)

• Primary Outcome: Group Differences in Supernatant IFN-gamma Concentration of DLST by AMPC in Children with Delayed AMPC Allergy and Normal Children

Secondary Outcome

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.

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: < 15age old
• Gender: Both

Include 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

Exclude 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.

Related Information

• Primary Sponsor: Yasuoka Ryuhei
• Source(s) of Monetary Support: Hamamatsu University School of Medicine FY2023 Intramural Research Project (Support Project for Young Researchers)