Beta-lactam allergy Drug hypersensitivity reaction Pediatric drug allergy Drug provocation test Non-severe cutaneous reaction Immediate allergic reaction Penicillin allergy Drug allergy delabeling Drug-induced skin reactions Beta-lactam allergy Drug hypersensitivity reactions Pediatric allergy Drug provocation test Non-severe cutaneous reaction Penicillin allergy Drug allergy delabeling
Conditions
Interventions
The group consists of children aged 3 to 18 years with a history of non-severe immediate-type allergic reactions to Beta-lactam antibiotics. The allergic reactions are limited to skin and/or mucosal i
Diagnostic
Direct DPT
Sponsors
Faculty of Medicine, Siriraj hospital, Mahidol University
Eligibility
Sex/Gender
All
Age
3 Years to 18 Years
Inclusion criteria
Inclusion criteria: 1. Children 3-18 years of age with history of Beta-lactam hypersensitivity reaction 2. Hypersensitivity reaction occurred within 1-6 hours after the last dose of drug administration 3. Hypersensitivity reaction is benign cutaneous reactions e.g., urticaria, angioedema, erythema/Flushing, pruritus, non specific rash
Exclusion criteria
Exclusion criteria: 1. Presents of any danger signs of hypersensitivity reaction e.g., palmo-plantar, genital, ear, and/or head itching, conjunctival redness 2. History of anaphylaxis to the challenge drug 3. History of nonimmediate hypersensitivity reaction, including severe cutaneous adverse drug eruption, e.g., Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP)) 4. Partly/Uncontrolled asthma or chronic lung disease (FEV1 <70%) during the challenge test 5. Uncontrolled chronic urticaria during the challenge test 6. Immunodeficiency patients 7. Study participant/parents cannot read the consent form in Thai
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of positive drug provocation test results to Beta-lactam drugs in children presented with intermediate hypersensitivity reaction Determine immediate hypersensitivity reactions occur within 90 minutes and non-immediate hypersensitivity reactions occur between 90 minutes to 48 hours after last dose of drug administration. Reproduces objective signs and symptoms compatible with drug hypersensitivity reactions | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety of DPT of Beta lactam to confirmed/delabeling children presented with intermediate hypersensitivity reaction within 2 hours and within 48 hours after drug administration Severity of the challenge reaction,Correlation of chronology of reactions between index and challenge reactions within 2 hours and within 48 hours after drug administration Challenge reaction | — |
Countries
Thailand
Contacts
Public ContactWITCHAYA SRISUWATCHARI
Faculty of Medicine Siriraj Hospital, Mahidol University
Outcome results
None listed