Testing for Betalactams Hypersensitivity in Children
Acquisition of Resistant Enterobacteria During Oral Drug Challenge for Betalactams in Children
This study is testing a new way to check if children with mild reactions to certain antibiotics are truly allergic to them by trying the medication directly over a longer period.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 0 Years to 17 Years |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Paris) |
| Trial ID | NCT04062344 on ClinicalTrials.gov |
What this trial studies
This study aims to confirm or exclude betalactams hypersensitivity in children aged 0-18 who report mild and delayed-onset reactions to these antibiotics. It involves direct drug provocation testing without prior skin or in vitro testing, which is considered the reference standard for diagnosis. The study will explore the effects of extending the duration of drug provocation testing from 2 days to up to 14 days to improve diagnostic performance while monitoring for potential emergence of bacterial resistance. Participants will be closely monitored for any adverse reactions during the testing period.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 0-18 who have experienced mild, delayed-onset reactions to betalactams.
Not a fit: Patients with a history of severe delayed-onset reactions or other severe chronic pathologies will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate diagnoses of betalactams hypersensitivity, allowing for appropriate antibiotic use and reducing unnecessary prescriptions of less effective alternatives.
How similar studies have performed: While the approach of drug provocation testing is established, the specific extension of testing duration to assess bacterial resistance has not been widely tested, making this a novel investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Paris
- Hôpital Necker-Enfants Malades — Paris, France (Recruiting)
Study contacts
- Principal investigator: Guillaume Lezmi, Doctor (PHU) — Assistance Publique - Hôpitaux de Paris
- Study coordinator: Guillaume Lezmi, Doctor (PHU)
- Email: guillaume.lezmi@aphp.fr
- Phone: +33 1 44 49 48 38
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.