Drug AllergyAllergyNCT07011212
In Search of the Correct Diagnosis of Beta-lactam Allergy: From the Validation of a Risk Stratification Tool to Accurate Endotyping
A study testing BL-Predicter in people with Drug Allergy, run by Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud.
Trial summary
Testing a clinical decision tool (BL-Predictor) Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Drug Allergy
- What is being tested?
- BL-Predicter
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 332 participants
- Where
- No sites listed yet
- Study dates
- Jul 2025to Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- signed informed consnet
Who cannot join
- Use of immunomodulators, antihistamines and corticosteroids
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Testing a clinical decision tool (BL-Predictor)
- Conditions
- Drug Allergy
- Being tested
- BL-Predicter
- Medical subject headings
- Drug Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BL-PredicterDiagnostic test
To Clinically validate the BL-Predictor toll by a randomised conytrolled ttrial
| Study group | Role | What they receive |
|---|---|---|
| BL Predictor | Experimental | Parallel,non-inferiority, randomised control trial will be conducted in patients with a low-risk score stratified by BL-Predictor Receives: 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 Receives: Diagnostic Test: BL-Predicter |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: April 2029- june 2027
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2025
- Study startJul 2025 (estimated)
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug AllergyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- If there are other parties who are masked in the clinical trial besides those listed above, use this space to describe those parties.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 332 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07011212
- Sponsor's protocol ID
- PI24/01913
- Other IDs
- PI24/01913
- Acronym
- Allergy
- Status last verified
- May 2025
- First submitted
- 28 Apr 2025
- Last updated
- 8 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Search of the Correct Diagnosis of Beta-lactam Allergy: From the Validation of a Risk Stratification Tool to Accurate Endotyping
- ClinicalTrials.gov ID
- NCT07011212
- Acronym / sponsor ID
- Allergy / PI24/01913
- Conditions
- Drug Allergy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 332 participants (estimated)
- Lead sponsor
- Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y SaludUniversity, hospital or other
- Study start
- Jul 2025 (estimated)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 8 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Testing a clinical decision tool (BL-Predictor)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- If there are other parties who are masked in the clinical trial besides those listed above, use this space to describe those parties.
| Arm | Type | Receives |
|---|---|---|
| BL Predictor | Experimental | Diagnostic Test: BL-PredicterParallel,non-inferiority, randomised control trial will be conducted in patients with a low-risk score stratified by BL-Predictor |
| control | Active comparator | Diagnostic Test: BL-PredicterSt followed, if negative,by a fractioned dose DTP wirth 30 min interval between doses: 25%-25%-50% of the maximun dose |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- signed informed consnet
Key exclusion criteria (1 listed)
- Use of immunomodulators, antihistamines and corticosteroids
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BL-PredicterTo Clinically validate the BL-Predictor toll by a randomised conytrolled ttrial | Diagnostic test | BL Predictor, control |
Primary outcome
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
Time frame: April 2029- june 2027
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing BL-Predicter in people with Drug Allergy, run by Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marina Labella Alvarez MLB Bonilla Toyos (+34951032058, elvira.bonilla@ibima.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: April 2029- june 2027). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2025.