In Search of the Correct Diagnosis of Beta-lactam Allergy: From the Validation of a Risk Stratification Tool to Accurate Endotyping

NCT07011212 | Not Yet Recruiting DMC

• 1 other identifier: PI24/01913
• Study Type: interventional
• Target: 332
• Locations: 0 countries
• Sites: N/A

Brief Summary

Testing a clinical decision tool (BL-Predictor)

Conditions

Drug Allergy

Outcome Measures

Primary Outcomes (1)

• The main goal of this project is to test a cliniacl decision toll to stratify BL allergic pataients in low and mediaum- anf high-risk

  And to carry out a deep dissection of the cellular mechanisms of B cells sensitization and basophil and neutrophil activation in BL-IRs to develop accurate in vitro diagnostic test

  April 2029- june 2027

Study Arms (2)

BL Predictor

EXPERIMENTAL

Parallel,non-inferiority, randomised control trial will be conducted in patients with a low-risk score stratified by BL-Predictor

Diagnostic Test: BL-Predicter

control

ACTIVE COMPARATOR

St followed, if negative,by a fractioned dose DTP wirth 30 min interval between doses: 25%-25%-50% of the maximun dose

Diagnostic Test: BL-Predicter

Interventions

BL-Predicter DIAGNOSTIC_TEST

To Clinically validate the BL-Predictor toll by a randomised conytrolled ttrial

BL Predictor; control

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• signed informed consnet

You may not qualify if:

• Use of immunomodulators, antihistamines and corticosteroids

Sponsors & Collaborators

• Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud: lead

MeSH Terms

Conditions

Drug Hypersensitivity

Condition Hierarchy (Ancestors)

Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders

Central Study Contacts

Marina Labella Alvarez MLB Bonilla Toyos

CONTACT

+34951032058; elvira.bonilla@ibima.eu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: If there are other parties who are masked in the clinical trial besides those listed above, use this space to describe those parties.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: If there are other parties who are masked in the clinical trial besides those listed above, use this space to describe those parties.

Study Record Dates

• First Submitted: April 28, 2025
• First Posted: June 8, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: June 8, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share