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Provocation After Nurse-Directed Assessment (PANDA) Study

Provocation After Nurse-Directed Assessment (PANDA) Study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07127835
Acronym
PANDAS
Enrollment
440
Registered
2025-08-17
Start date
2025-09-01
Completion date
2029-08-31
Last updated
2026-04-29

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

Conditions

Drug Allergy, Penicillin Allergy

Keywords

Nurse-led Service, Drug Provocation Test, Delabelling

Brief summary

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.

Detailed description

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.

Interventions

DIAGNOSTIC_TESTNurse-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.

DIAGNOSTIC_TESTAllergist-led penicillin allergy delabelling service

Patients assigned to this group will undergo risk assessment and delabeling led by allergists for both low-risk and high-risk cases.

Sponsors

The University of Hong Kong
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

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

Inclusion criteria

* Receiving inpatient or outpatient treatment at a participating hospital during the study period; * Possessing a documented penicillin allergy label; * Underwent penicillin allergy evaluation by the nurse-allergist collaborative approach or the traditional allergist-led approach * Demographic and clinical data required for the study available.

Exclusion criteria

* Patients unable to provide a complete medication history or history of penicillin allergy; * Patients with only emergency or short-term treatment records; * Patients who have taken steroids, antihistamines, or similar medications within the last 3 days.

Design outcomes

Primary

MeasureTime frameDescription
Delabelling Success Rate6 monthsAssess the proportion of low-risk patients who are no longer considered allergic to penicillin after delabeling.

Secondary

MeasureTime frameDescription
Health-Related Quality of Life6 monthsMeasure 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).
Antibiotic Usage Rate6 monthsEvaluate changes in the usage rates of penicillin and alternative antibiotics after delabeling.
Age Group Analysis6 monthsCompare delabeling success rates across different age groups (e.g., 18-30 years, 31-50 years, and 51 years and older).
Immunocompetence Status6 monthsAnalyze differences in delabeling success rates and safety between immunocompetent and immunocompromised patients.
Initial vs. Recurrent Labeling6 monthsCompare delabeling success rates between patients with an initial penicillin allergy label and those with recurrent labels.

Countries

Hong Kong

Contacts

CONTACTElaine Lee
le446@hku.hk852 9440 3349

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 30, 2026