Hôpital Necker - Enfants Malades
Paris, 75015, France
Location status: Recruiting
NCT Number: NCT07002814
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.
Interested in participating?
Request InfoUp to 17 year
All sexes
Observational
Paris, 75015, France
Location status: Recruiting
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Day 14
Collect and compare the nature of reactions between children with positive and negative direct oral challenge
Time frame: Day 14
Collect and compare chronology of reactions between children with positive and negative direct oral challenge.
Time frame: Day 14
Collect and compare duration of reactions between children with positive and negative direct oral challenge.
Time frame: Day 14
Index reactions between children with positive and negative direct oral challenge.
Time frame: Day 14
Collect and analyse the nature of reactions in positive direct oral challenge
Time frame: Day 14
Collect and analyse the extension of reactions in positive direct oral challenge
Time frame: Day 14
Collect and analyse the duration of reactions in positive direct oral challenge
Contact information is provided by the study sponsor or research team.
Assistance Publique - Hôpitaux de Paris
Other
Feasibility of Direct Oral Challenges in Private Practice Setting for the Evaluation of Mild Delayed Reactions to Beta-lactams in Children
Acronym: Betalactaville
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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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