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A Penicillin Allergy Delabeling Inhospital Model Hospitalized Patients

Design, Implementation and Analysis of a Penicillin Allergy Delabeling Model in Hospitalized Patients

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07194824
Acronym
Des-Al-Pen
Enrollment
165
Registered
2025-09-26
Start date
2024-04-04
Completion date
2025-05-25
Last updated
2026-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allergy Drug, Allergy Penicillin

Keywords

De-labelling, Allergy manegement, beta-lactans allergy

Brief summary

Design, implementation and analysis of an allergy assessment and management model beta-lactams in hospitalized patients

Detailed description

To evaluate the impact of a healthcare process for risk stratification based on the clinical history and the application of a structured questionnaire, on the Proportion of hospitalized patients in whom the penicillin allergy label is removed

Interventions

OTHERPragmatic allergy management according to risk stratification

Intervention based on allergy risk stratification. Tipus A) Patients in this group can undergo direct delabeling without the need for exposure, with this being documented in the EMR. If the patient refuses, an exposure to penicillin and/or cephalosporin will be performed. Once completed, de-labeling can proceed without the need for re-exposure. Tipus B) Indication for use of a penicillin: Oral exposure to 250 mg of amoxicillin. \- Indication for cephalosporin : administration of a cephalosporin that exhibits the lowest level of cross-reactivity with penicillin. Re-exposure to penicillin/ cephalosporin or both is performed at least 2 weeks after the first tolerated exposure. De-labeling is performed when tolerance to re-exposure is verified. Tipus C) These high-risk patients are managed following the protocol for the treatment of patients with beta-lactam allergy, referring them to allergy consultation for further specific test.

Sponsors

Althaia Xarxa Assistencial Universitària de Manresa
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Clinical evaluation study of a new care process, prospective, open, carried out in a single centre, ALTHAIA University Assistance Network of Manresa.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Age \> 18 years * Ability to understand the study after reading the patient information sheet (Appendix II) and providing signed consent for participation (Appendix III: informed consent form). * Patients with a reported allergy to penicillin and/or cephalosporins that has not been investigated or with inconclusive prior testing.

Exclusion criteria

\- None

Design outcomes

Primary

MeasureTime frameDescription
Proportion of patients hospitalized in which the penicillin allergy label is removedAt enrollment timeProportion of patients hospitalized in which the penicillin allergy label is removed

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026