Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04827602
Other study ID # GEH-R-20068776
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 15, 2021
Est. completion date July 15, 2021

Study information

Verified date May 2022
Source University Hospital, Gentofte, Copenhagen
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 849
Est. completion date July 15, 2021
Est. primary completion date July 15, 2021
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Penicillin allergy tested at the Allergy Clinic, Copenhagen University Hospital - Herlev and Gentofte, Copenhagen, Denmark in 2017-2019 Exclusion Criteria: -

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Drug allergy label status in electronic health records
Registered drug allergy labels in primary care and hospital electronic medical charts

Locations

Country Name City State
Denmark Allergy Clinic, Department of Dermato-Allergology, Copenhagen University Hospital Copenhagen

Sponsors (2)

Lead Sponsor Collaborator
University Hospital, Gentofte, Copenhagen Research Unit Of General Practice, Copenhagen

Country where clinical trial is conducted

Denmark, 

References & Publications (3)

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 — View Citation

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. Review. — View Citation

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). pii: e20173466. doi: 10.1542/peds.2017-3466. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other 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. Baseline
Primary 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 Baseline
Secondary Degree of match between registered drug allergy labels Degree of match between registered drug allergy labels in primary care and hospital electronic health records Baseline
See also
  Status Clinical Trial Phase
Completed NCT02839551 - Optimal Doses for Drug Provocation Tests to Beta-lactams N/A
Completed NCT00198419 - Hypersensitivity Reaction to Vitrase (Ovine Hyaluronidase) Phase 1
Completed NCT02839811 - Medical Device for Drug Allergy Diagnosis N/A
Completed NCT02983630 - Allergy Testing of Patients Labeled as Penicillin Allergic N/A
Completed NCT00198458 - Hypersensitivity Reaction to Vitrase (Ovine Hyaluronidase) Phase 1
Recruiting NCT04330118 - Origin and Function of Eosinophilic Polynuclear During DRESS Syndrome
Completed NCT04421638 - Cephalosporin Hypersensitivity
Recruiting NCT02031120 - Management of Drug Hypersensitivity in Children N/A
Completed NCT01276314 - Evaluation of TNF-α Blockade Effect in Patients With Severe Cutaneous Adverse Drug Reactions N/A
Terminated NCT00505648 - Treatment of Hypersensitivity Syndrome (DRESS) With Tegeline® (Human Immunoglobulin) Phase 3
Completed NCT03158831 - Drug Challenges Without Prior Skin Testing Phase 1
Completed NCT03076749 - Predictive Models for Betalactam Allergy N/A
Active, not recruiting NCT06428162 - An Evaluation of Healthcare Providers' Adherence to Pharmacovigilance Practices in an African Community
Terminated NCT02844712 - Negative Predictive Value of Drug Provocation Tests to Beta-lactams N/A
Completed NCT03771118 - Drug Provocation Test (DPT) to Paracetamol
Completed NCT03743220 - Drug Provocation Test (DPT) to Non Steroidal Anti-inflammatory Drugs (NSAID)
Not yet recruiting NCT06406114 - Optimizing the Diagnostic Approach to Cephalosporin Allergy Testing Phase 2
Completed NCT05269082 - A Study to Assess the Hypersensitivity to TAK-880 Compared to Gammagard S/D in Blood of Children, Teenagers and Adults