Status:
RECRUITING
Acquisition of Resistant Enterobacteria During Oral Drug Challenge for Betalactams in Children
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Betalactams Hypersensitivity
Eligibility:
All Genders
Up to 17 years
Brief Summary
Direct drug provocation testing, without prior skin or in vitro testing, is the reference standard for confirming the diagnosis of drug hypersensitivity reactions in children reporting mild and delaye...
Detailed Description
Drug hypersentivity in children is suspected in up to 10% of parents. However, drug hypersensitivity is rarely confirmed: its prevalence in children is estimated to be less than 0.5%. The most frequen...
Eligibility Criteria
Inclusion
- Inclusion Criteria :
- Minors aged 0 to 18
- Consultation in Necker for an oral drug provocation test to explore mild (urticaria, edema, maculo-papulous exanthema) delayed-onset reaction (1 hour after initiation of treatment) to betalactams (amoxicillin +/-clavulanic acid, cefpodoxime, cefixime, cefuroxime)
- Exclusion Criteria :
- Minors with potentially severe delayed-onset reactions (painful skin lesions, atypical target lesions, erosions of mucosa, centro facial oedema, purpuric infiltrated papules) or severe (Lyell/Stevens Johnson Syndrome, fixed drug eruption, acute generalized exanthematous pustulosis, skin rash with systemic and hypereosinophilic disorders)
- Antibiotic treatment within the past month before the drug provocation test
- Travel abroad within the past 6 months before the drug provocation test
- Cardio-respiratory failure, renal failure, hepatic impairment or any other severe chronic pathology
Exclusion
Key Trial Info
Start Date :
March 23 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 1 2025
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT04062344
Start Date
March 23 2021
End Date
March 1 2025
Last Update
October 30 2024
Active Locations (1)
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1
Hôpital Necker-Enfants Malades
Paris, Paris, France, 75015