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CompletedNCT04827602Updated May 26, 2022

Drug Allergy Labels After Drug Allergy Investigation

An observational study in Drug Hypersensitivity, sponsored by University Hospital, Gentofte, Copenhagen. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-05-26.

Sponsored by University Hospital, Gentofte, Copenhagen · Observational

Study type
Observational
Model
Ecologic or community
Time perspective
Cross-sectional
Enrollment
849
Ages
18 Years and older
Sex
All
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Study summary

The aim of this study is to investigate the degree of match between the drug allergy label in the hospital's electronic health record and primary care's electronic health record among patients who previously have been drug allergy tested.

Read the detailed description

Patients who previously have been penicillin allergy tested in 2017 to 2019 at the Allergy Clinic at Gentofte Hospital is included in the study. Patients are identified through a drug allergy database at the department.

A letter describing the study and the data collection process will be sent to the patients' General Practice offices (GP).

Data collection: The patients GP's are contacted by telephone where the information about the drug allergy labels in their electronical medical charts are shared. On the same day as the phone contact to the GP's office, the patient's electronical health record in the hospital system is accessed in order to gain information about the current drug allergy registrations.

Predictors for the explanatory analysis is collected partly through the phone call to the GP (such as numbers of patients and physicians at each GP and the electronic health system used), from the hospital electronic health record (such as number of hospital admissions since drug allergy testing) and from the drug allergy database.

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Conditions studied

  • Drug Hypersensitivity

Keywords

  • drug allergy
  • drug allergy labels
  • penicillin allergy labels
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In context

Hypersensitivity

1,916 studies on the registry are indexed under Hypersensitivity; 265 are open to participants now.

This study's enrollment of 849 is above the median of 115 across 479 observational studies indexed under Hypersensitivity.

Browse Hypersensitivity studies →

Lead sponsor

University Hospital, Gentofte, Copenhagen is the lead sponsor of 154 studies on the registry; 9 are open to participants now.

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

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

Study population

The study population is made up of patients who completed penicillin allergy testing in 2017 to 2019 at the Allergy Clinic, Copenhagen University Hospital - Herlev and Gentofte, Copenhagen, Denmark. The study population is estimated to 900 participants from both the Capital Region and Region Zealand.

Inclusion criteria

  • Penicillin allergy tested at the Allergy Clinic, Copenhagen University Hospital - Herlev and Gentofte, Copenhagen, Denmark in 2017-2019

Exclusion criteria

Exclusion Criteria:

-

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Study design

Observational model
Ecologic or community
Time perspective
Cross-sectional
Enrollment
849 participants (actual)
Patient registry
No

Groups and cohorts

  • Allergy tested group

    Patients who have completed penicillin allergy testing

    Other: Drug allergy label status in electronic health records

Interventions

  • OtherDrug allergy label status in electronic health records

    Registered drug allergy labels in primary care and hospital electronic medical charts

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What researchers measure

Primary outcomes

  1. Degree of matching drug allergy testing and drug allergy labels

    Degree of match between allergy testing outcomes and registered drug allergy labels in primary care and hospital electronic health records

    Time frame: Baseline

Secondary outcomes

  1. Degree of match between registered drug allergy labels

    Degree of match between registered drug allergy labels in primary care and hospital electronic health records

    Time frame: Baseline

Other outcomes

  1. Analysis of predictors for failure to update drug allergy labels

    Exploratory analysis of predictors for failure to update the drug allergy labels. Predictors include sex, age, immediate/delayed index allergic reaction, drug allergy test results, patients pr GP, doctors pr GP, electronic system used, drug allergy test referrals from the same GP, drug allergy labels pr patient and admissions since drug allergy testing pr patient.

    Time frame: Baseline

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Study locations

1 site
  • Allergy Clinic, Department of Dermato-Allergology, Copenhagen University Hospital
    Copenhagen, 2900, Denmark
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References and documents

Publications

  • Lachover-Roth I, Sharon S, Rosman Y, Meir-Shafrir K, Confino-Cohen R. Long-Term Follow-Up After Penicillin Allergy Delabeling in Ambulatory Patients. J Allergy Clin Immunol Pract. 2019 Jan;7(1):231-235.e1. doi: 10.1016/j.jaip.2018.04.042. Epub 2018 May 22. PubMed 29800754 ↗
  • Vyles D, Chiu A, Routes J, Castells M, Phillips EJ, Kibicho J, Brousseau DC. Antibiotic Use After Removal of Penicillin Allergy Label. Pediatrics. 2018 May;141(5):e20173466. doi: 10.1542/peds.2017-3466. PubMed 29678929 ↗
  • Sacco KA, Bates A, Brigham TJ, Imam JS, Burton MC. Clinical outcomes following inpatient penicillin allergy testing: A systematic review and meta-analysis. Allergy. 2017 Sep;72(9):1288-1296. doi: 10.1111/all.13168. Epub 2017 Apr 26. PubMed 28370003 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 26, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04827602
Lead sponsor
University Hospital, Gentofte, Copenhagen
Collaborators
Research Unit Of General Practice, Copenhagen
Responsible party
Sara Fransson (Ph.D student, University Hospital, Gentofte, Copenhagen) — Principal investigator
First posted
Apr 1, 2021
Start date
Apr 15, 2021
Primary completion
Jul 15, 2021
Completion
Jul 15, 2021
Last update
May 26, 2022

Study contacts

Lene H. Garvey
principal investigator · Allergy Clinic, Copenhagen University Hospital, Copenhagen

Oversight

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

Not currently enrolling

This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.

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