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

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

Status: Not yet enrolling

Conditions: Drug Allergy

Treatments: Diagnostic Test: BL-Predicter

Study type: Interventional

Funder types: Other

Identifiers

NCT07011212

PI24/01913 (Registry Identifier)

Details and patient eligibility

About

Testing a clinical decision tool (BL-Predictor)

Enrollment: 332 estimated patients

Sex: All

Ages: 14+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• signed informed consnet

Exclusion criteria

• Use of immunomodulators, antihistamines and corticosteroids

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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332 participants in 2 patient groups

BL Predictor

Experimental group

Description:

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

Treatment:

Diagnostic Test: BL-Predicter

control

Active Comparator group

Description:

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

Treatment:

Diagnostic Test: BL-Predicter