An observational study in Drug Allergy and Penicillin Allergy, sponsored by The University of Hong Kong. Recruiting at 4 sites in Hong Kong. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-29.
Sponsored by The University of Hong Kong · Observational
The study aims to evaluate the effectiveness and safety of a collaborative nurse-allergist approach in penicillin allergy delabeling services. It also seeks to assess the impact on patients' quality of life and compare resource utilization and cost-effectiveness between the nurse-allergist collaborative approach and the traditional allergist-led approach.
This study hypothesizes that by involving both nurses and allergists in the delabeling process and categorizing patients based on risk levels, it will achieve comparable success rates, safety, and improvements in patients' quality of life. This approach is expected to offer superior advantages in terms of time efficiency, resource utilization, and cost-effectiveness compared to traditional allergist-led services.
66 studies on the registry are indexed under Drug Hypersensitivity; 20 are open to participants now.
This study's planned enrollment of 440 is above the median of 200 across 28 observational studies indexed under Drug Hypersensitivity.
Browse Drug Hypersensitivity studies →The University of Hong Kong is the lead sponsor of 1,262 studies on the registry; 340 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients treated at a participating hospital who have a documented penicillin allergy label, are evaluated for penicillin allergy through either the nurse-allergist or allergist-led approach, and have available demographic and clinical data.
Exclusion Criteria:
Receive Nurse-led penicillin allergy delabelling service
Diagnostic Test: Nurse-led penicillin allergy delabelling service
Receive Allergist-led penicillin allergy delabelling service
Diagnostic Test: Allergist-led penicillin allergy delabelling service
Patients in this group undergo risk assessment and categorization by nurses to identify low-risk individuals for delabeling. For these patients, nurses will collaborate with allergists in the delabeling process.
Patients assigned to this group will undergo risk assessment and delabeling led by allergists for both low-risk and high-risk cases.
Delabelling Success Rate
Assess the proportion of low-risk patients who are no longer considered allergic to penicillin after delabeling.
Time frame: 6 months
Health-Related Quality of Life
Measure changes in patients' quality of life before and after delabeling using the validated Drug Hypersensitivity Quality of Life Questionnaire (DrHy-Q). The DrHy-Q is a 15-item instrument answered on a 5-point Likert scale, with scores ranging from 15 (no QoL impairment) to 225 (worst QoL impairment).
Time frame: 6 months
Antibiotic Usage Rate
Evaluate changes in the usage rates of penicillin and alternative antibiotics after delabeling.
Time frame: 6 months
Age Group Analysis
Compare delabeling success rates across different age groups (e.g., 18-30 years, 31-50 years, and 51 years and older).
Time frame: 6 months
Immunocompetence Status
Analyze differences in delabeling success rates and safety between immunocompetent and immunocompromised patients.
Time frame: 6 months
Initial vs. Recurrent Labeling
Compare delabeling success rates between patients with an initial penicillin allergy label and those with recurrent labels.
Time frame: 6 months
Plan to share: Undecided
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions 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.
The University of Hong Kong