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NCT Number: NCT07002814

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

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.

Recruiting

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Key information

Age range

Up to 17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Necker - Enfants Malades

Paris, 75015, France

Location status: Recruiting

About this study

Approximately 10% of children are labeled as allergic to beta-lactams (BL). Consequently, they receive alternative antibiotics with a broader spectrum but lower efficacy, leading to increased infectious morbidity and mortality, a higher risk of colonization with antibiotic-resistant bacteria, and elevated healthcare costs. However, true BL allergy is only confirmed in 5-10% of cases. Therefore, an essential challenge is to promptly identify non-allergic children to prevent unnecessary medical restrictions.

The most common reactions are delayed and benign. Current guidelines recommend evaluating these reactions through direct oral challenge (DOC) without prior allergological assessment, as traditional diagnostic methods, particularly skin tests, have poor sensitivity in this context. However, the optimal setting for conducting these tests remains debated, particularly regarding whether they can be initiated in hospital settings or private medical practices.

To date, over 8,300 DOCs have been performed in children, predominantly in hospital-based consultations. These tests have demonstrated a favorable safety profile, with positive DOC reactions often being of the same nature and less severe than the initial reported reaction. While many physicians perform DOCs in private practice, data on their use in pediatric populations remain scarce.

The primary objective of this study is to assess the feasibility of DOCs conducted in private medical practices for children with suspected benign delayed allergy to BL

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Population: Children's age between 0 and 17 years
  • Child who has undergone a direct oral challenge in a private medical practice and a follow-up consultation within 7 to 14 days for suspected delayed allergy to amoxicillin +/- clavulanate or cefpodoxime or cefixime with the following characteristics:
  • 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).

Exclusion criteria

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

Treatment and study plan

Primary outcomes

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

    Time frame: Day 14

    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.

Secondary outcomes

  1. Negative and positive tests reaction nature comparison

    Time frame: Day 14

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

  2. Negative and positive tests reaction chronology comparison

    Time frame: Day 14

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

  3. Negative and positive tests reaction duration comparison

    Time frame: Day 14

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

  4. Negative and positive tests reactions index comparison

    Time frame: Day 14

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

  5. Reactions nature in positive tests

    Time frame: Day 14

    Collect and analyse the nature of reactions in positive direct oral challenge

  6. Reactions extension in positive tests

    Time frame: Day 14

    Collect and analyse the extension of reactions in positive direct oral challenge

  7. Reactions duration in positive tests

    Time frame: Day 14

    Collect and analyse the duration of reactions in positive direct oral challenge

Study contacts

Contact information is provided by the study sponsor or research team.

Gael Plastow

CONTACT

[email protected]

01 44 38 18 57 ext. +33

Sebastien LE, MD

CONTACT

[email protected]

06 35 14 12 41 ext. +33

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • URC-CIC Paris Descartes Necker Cochin

Registry information

Official study title

Feasibility of Direct Oral Challenges in Private Practice Setting for the Evaluation of Mild Delayed Reactions to Beta-lactams in Children

Acronym: Betalactaville

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Jun 4, 2025
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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