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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
TCTR
Registry ID
TCTR20170106001
Enrollment
140
Registered
2017-01-06
Start date
2017-01-01
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Occurrence of any abnormal clinical symptoms and signs Rash Angioedema Rhinitis Wheezing GI involvement Anaphylaxis Non&#45

Interventions

Perform oral provocation test without skin testing.
Experimental Procedure/Surgery
PSU 2 steps challenge

Sponsors

Prince of Songkla University Ethics Committee of Human Research
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 15 Years

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
N/A N/A N/A

Countries

Thailand

Contacts

Public ContactDuangdee Wantanaset

Unaffiliated

duangdee.tsw@gmail.com0858855177

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026