CClinicalTrials.gg
Not yet recruitingNCT07011212AllergyUpdated Jun 8, 2025

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

An interventional study of BL-Predicter in Drug Allergy, sponsored by Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud. Not yet recruiting. Open to participants aged 14 Years and older. Per ClinicalTrials.gov, last updated 2025-06-08.

Sponsored by Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
332
Allocation
Randomized
Ages
14 Years and older
Sex
All
01

Study summary

Testing a clinical decision tool (BL-Predictor)

02

Conditions studied

03

In context

Hypersensitivity

1,914 studies on the registry are indexed under Hypersensitivity; 265 are open to participants now.

This study's planned enrollment of 332 is above the median of 57 across 1,382 interventional studies indexed under Hypersensitivity.

Browse Hypersensitivity studies →

Lead sponsor

Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud is the lead sponsor of 71 studies on the registry; 23 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
14 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • signed informed consnet

Exclusion criteria

Exclusion Criteria:

  • Use of immunomodulators, antihistamines and corticosteroids
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
332 participants (estimated)

Study arms

  • Experimental
    BL Predictor

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

    Diagnostic Test: BL-Predicter

  • Active comparator
    control

    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

  • Diagnostic testBL-Predicter

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

06

What researchers measure

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

    Time frame: April 2029- june 2027

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 8, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07011212
Lead sponsor
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
Responsible party
Sponsor
First posted
Jun 8, 2025
Start date
Jul 2025 (estimated)
Primary completion
Jul 2027 (estimated)
Completion
Jul 2027 (estimated)
Last update
Jun 8, 2025

Study contacts

Marina Labella Alvarez MLB Bonilla Toyos
Contact
elvira.bonilla@ibima.eu
+34951032058

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in May 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion