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

NCT ID: NCT07011212

Last Updated: 2025-06-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

332 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-31

Study Completion Date

2027-07-31

Brief Summary

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Testing a clinical decision tool (BL-Predictor)

Detailed Description

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Conditions

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Drug Allergy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

If there are other parties who are masked in the clinical trial besides those listed above, use this space to describe those parties.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
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Study Groups

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BL Predictor

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

Group Type EXPERIMENTAL

BL-Predicter

Intervention Type DIAGNOSTIC_TEST

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

control

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

Group Type ACTIVE_COMPARATOR

BL-Predicter

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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BL-Predicter

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* signed informed consnet

Exclusion Criteria

* Use of immunomodulators, antihistamines and corticosteroids
Minimum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Marina Labella Alvarez MLB Bonilla Toyos

Role: CONTACT

+34951032058

Other Identifiers

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PI24/01913

Identifier Type: REGISTRY

Identifier Source: secondary_id

PI24/01913

Identifier Type: -

Identifier Source: org_study_id

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