Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07127835

Provocation After Nurse-Directed Assessment (PANDA) Study

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Drug Allergy Chemically-Induced Disorders Drug Hypersensitivity Drug-Related Side Effects and Adverse Reactions Penicillin Allergy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Prince of Wales Hospital, Hong Kong

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nurse-led penicillin allergy delabelling service

Diagnostic Test

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.

Allergist-led penicillin allergy delabelling service

Diagnostic Test

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

Primary outcomes

  1. Delabelling Success Rate

    Time frame: 6 months

    Assess the proportion of low-risk patients who are no longer considered allergic to penicillin after delabeling.

Secondary outcomes

  1. Health-Related Quality of Life

    Time frame: 6 months

    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).

  2. Antibiotic Usage Rate

    Time frame: 6 months

    Evaluate changes in the usage rates of penicillin and alternative antibiotics after delabeling.

  3. Age Group Analysis

    Time frame: 6 months

    Compare delabeling success rates across different age groups (e.g., 18-30 years, 31-50 years, and 51 years and older).

  4. Immunocompetence Status

    Time frame: 6 months

    Analyze differences in delabeling success rates and safety between immunocompetent and immunocompromised patients.

  5. Initial vs. Recurrent Labeling

    Time frame: 6 months

    Compare delabeling success rates between patients with an initial penicillin allergy label and those with recurrent labels.

Study contacts

Contact information is provided by the study sponsor or research team.

Elaine Lee

CONTACT

[email protected]

852 9440 3349

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Registry information

Acronym: PANDAS

Important dates

Study start
2025
Primary completion
2027
Study completion
2029
First posted
Aug 17, 2025
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.