Provocation After Nurse-Directed Assessment (PANDA) Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorThe University of Hong Kong
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
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.
Trial design
Design model
Case-only
Time perspective
Retrospective
Treatments tested in this trial
Nurse-led penicillin allergy delabelling service
Diagnostic testPatients 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 testPatients assigned to this group will undergo risk assessment and delabeling led by allergists for both low-risk and high-risk cases.
Treatment groups
440 Participants
are divided into 2 treatment groupsGroup A: Nurse-led group1 intervention
Group B: Allergist-led group1 intervention
Trial outcomes
Primary outcomes
1
Delabelling Success Rate
Assess the proportion of low-risk patients who are no longer considered allergic to penicillin after delabeling.
Time frame
6 monthsSecondary outcomes
1
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 months2
Antibiotic Usage Rate
Evaluate changes in the usage rates of penicillin and alternative antibiotics after delabeling.
Time frame
6 months3
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 months4
Immunocompetence Status
Analyze differences in delabeling success rates and safety between immunocompetent and immunocompromised patients.
Time frame
6 monthsSponsors and contacts
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Source ClinicalTrials.gov