Safety of amoxicillin provocation test using PSU 2 steps challenge in children with a history of non-immediate reactio

Not Applicable

Recruiting

• Conditions: Occurrence of any abnormal clinical symptoms and signsRashAngioedemaRhinitis WheezingGI involvementAnaphylaxis; Non- immediate reaction; Amoxicillin; Amoxicillin/clavulanic acid; Oral provocation test; No skin testing; children; hypersensitivity

• Registration Number: TCTR20170106001
• Lead Sponsor: Prince of Songkla University Ethics Committee of Human Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-06
• Study Completion: 2017-12-30
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

History of urticaria/angioedema or maculopapular exanthema eruption more than 2 hour after amoxicillin or amoxicillin/clavulanic acid administration

Exclusion Criteria

- History of anaphylaxis
- History of life-threatening non-IgE-mediated eg. Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug rash with eosinophillia and systemic syndrome (DRESS), acute generalized exanthematous pustulosis (AGEP), exfoliative dermatitis, vasculitis และ severe maculopapular eruption (MPE)
- Uncontrolled chronic disease
- Patient who are at risk of severe anaphylaxis eg, systemic mastocytosis, hereditary angioedema, beta-blockers or angiotensin-converting enzyme (ACE) inhibitors using

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety of amoxicillin provocation test using PSU 2 steps challenge within 7 days since the start of drug provocation test Occurence of any adverse reaction from oral amoxicillin provocation test

Secondary Outcome Measures

Name	Time	Method
/A N/A N/A