Direct Oral Challenges in Private Practice Setting to Delabeling Children With Beta-lactam Allergy

ConditionAllergy
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 17
SponsorAssistance Publique - Hôpitaux de Paris

About this trial

The purpose of this study is to demonstrate the feasibility of direct oral challenge performed in private practice setting for children with suspected benign delayed allergy to beta-lactams.

The results of this study could help establish recommendations for conducting direct oral challenge in primary care settings to delabeling children with benign delayed reactions to beta-lactams.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Population: Children's age between 0 and 17 years

delayed reaction (onset > 1 hour after treatment start),

mild reaction (isolated urticaria or Maculopapular exanthema),

Absence of warning signs suggestive of a severe cutaneous adverse reaction (erythroderma, presence of bullae, vesicles, pustules, target lesions, involvement of oral, genital, or ocular mucosa, facial edema, general condition impairment, organ failure, duration > 7 days).

Disqualifiers

Informed children or holders of parental authority objecting to the use of patient data in the study.

Trial population

Child who underwent a direct oral challenge in a private practice setting for suspected mild delayed allergy to a beta-lactam

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

Not listed

Trial groups

200 Participants
are grouped into 1 trial group
Group A: Children requiring a direct oral challenge (DOC)

Trial outcomes

Primary outcomes

1

Feasibility of direct oral challenge (DOC) for beta-lactam allergy assessment

Demonstrate the feasibility of direct oral challenges (DOCs) performed in private medical practices for the evaluation of delayed and benign reactions to beta-lactams in children by collecting the amount of positive and negative DOC results and benign reactions description.

Time frame
Day 14

Secondary outcomes

1

Negative and positive tests reaction nature comparison

Collect and compare the nature of reactions between children with positive and negative direct oral challenge

Time frame
Day 14
2

Negative and positive tests reaction chronology comparison

Collect and compare chronology of reactions between children with positive and negative direct oral challenge.

Time frame
Day 14
3

Negative and positive tests reaction duration comparison

Collect and compare duration of reactions between children with positive and negative direct oral challenge.

Time frame
Day 14
4

Negative and positive tests reactions index comparison

Index reactions between children with positive and negative direct oral challenge.

Time frame
Day 14

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Assistance Publique - Hôpitaux de Paris

Lead sponsor

URC-CIC Paris Descartes Necker Cochin

Collaborator