RecruitingNCT04062344

Acquisition of Resistant Enterobacteria During Oral Drug Challenge for Betalactams in Children


Sponsor

Assistance Publique - Hôpitaux de Paris

Enrollment

300 participants

Start Date

Mar 23, 2021

Study Type

OBSERVATIONAL

Conditions

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 delayed-onset reactions. However, optimal protocol(s) have not been standardized. Although a 2-days' provocation testing protocol is effective, increasing its duration (up to 14 days) may improve its diagnosis performance without increasing the risk of severe reactions. However, a prolonged provocation testing could increase the risk of emergence of bacterial resistances in the digestive flora. Longer duration could be associated with the emergence of extended-spectrum betalactamase producing enterobacteria. However, this point has never been confirmed. The study will include children (0-18 years); referring for histories of mild and delayed-onset reactions to betalactams. drug provocation testing will be performed with the suspected BLs in our department, as in clinical practice. Two groups of patients will be compared: a group performing short provocation testing (arbitrary defined as lasting 1 to 4 days) and a group with prolonged drug provocation testing (arbitrary defined as lasting 5-8 days). A rectal swab will be collected for each patient before the provocation testing, a second one at the end of the provocation testing. Each sample will be analyzed to detect the presence extended-spectrum betalactamase -producing enterobacteria.


Eligibility

Min Age: 0 YearsMax Age: 17 Years

Inclusion Criteria2

  • 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 Criteria4

  • 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

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

OTHERSwab

Rectal swab before and after the drug provocation testing


Locations(1)

Hôpital Necker-Enfants Malades

Paris, Paris, France

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT04062344