Drug AllergyPANDASNCT07127835
Provocation After Nurse-Directed Assessment (PANDA) Study
An observational study of Drug Allergy and Penicillin Allergy, run by The University of Hong Kong at 4 sites in Hong Kong.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Drug Allergy, Penicillin Allergy
- What is being tested?
- Nurse-led penicillin allergy delabelling service and Allergist-led penicillin allergy delabelling service
- How many people
- 440 participants
- Where
- 4 sitesHong Kong
- Study dates
- 1 Sep 2025to 31 Aug 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study 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.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong4 sites, 4 recruiting
- Recruiting
Prince of Wales Hospital
Hong Kong, 999077
- Recruiting
Princess Margaret Hospital
Hong Kong, 999077
- Recruiting
Queen Elizabeth Hospital
Hong Kong, 999077
- Recruiting
Queen Mary Hospital
Hong Kong, 999077
About this 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.
Read the 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.
- Conditions
- Drug Allergy, Penicillin Allergy
- Being tested
- Nurse-led penicillin allergy delabelling service, Allergist-led penicillin allergy delabelling service
- Keywords
- Nurse-led Service, Drug Provocation Test, Delabelling
- Medical subject headings
- Drug Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nurse-led penicillin allergy delabelling serviceDiagnostic 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 serviceDiagnostic test
Patients assigned to this group will undergo risk assessment and delabeling led by allergists for both low-risk and high-risk cases.
| Study group | Role | What they receive |
|---|---|---|
| Nurse-led group | Receive Nurse-led penicillin allergy delabelling service Receives: Diagnostic Test: Nurse-led penicillin allergy delabelling service | |
| Allergist-led group | Receive Allergist-led penicillin allergy delabelling service Receives: Diagnostic Test: Allergist-led penicillin allergy delabelling service |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delabelling Success Rate
Assess the proportion of low-risk patients who are no longer considered allergic to penicillin after delabeling.
Measured: 6 months
Secondary outcomes (5)
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).
Measured: 6 months
Antibiotic Usage Rate
Evaluate changes in the usage rates of penicillin and alternative antibiotics after delabeling.
Measured: 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).
Measured: 6 months
Immunocompetence Status
Analyze differences in delabeling success rates and safety between immunocompetent and immunocompromised patients.
Measured: 6 months
Initial vs. Recurrent Labeling
Compare delabeling success rates between patients with an initial penicillin allergy label and those with recurrent labels.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2025
- Study start1 Sep 2025
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Drug AllergyStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 440 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Sophia Siu-chee Chan, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07127835
- Sponsor's protocol ID
- PANDAstudy
- Acronym
- PANDAS
- Status last verified
- Aug 2025
- First submitted
- 10 Aug 2025
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Schnyder B, Pichler WJ. Mechanisms of drug-induced allergy. Mayo Clin Proc. 2009 Mar;84(3):268-72. doi: 10.4065/84.3.268.
PubMed 19252115Abrams EM, Khan DA. Diagnosing and managing drug allergy. CMAJ. 2018 Apr 30;190(17):E532-E538. doi: 10.1503/cmaj.171315. No abstract available.
PubMed 29712672Classen DC, Pestotnik SL, Evans RS, Lloyd JF, Burke JP. Adverse drug events in hospitalized patients. Excess length of stay, extra costs, and attributable mortality. JAMA. 1997 Jan 22-29;277(4):301-6.
PubMed 9002492Pourpak Z, Fazlollahi MR, Fattahi F. Understanding adverse drug reactions and drug allergies: principles, diagnosis and treatment aspects. Recent Pat Inflamm Allergy Drug Discov. 2008 Jan;2(1):24-46. doi: 10.2174/187221308783399289.
PubMed 19075990Patton K, Borshoff DC. Adverse drug reactions. Anaesthesia. 2018 Jan;73 Suppl 1:76-84. doi: 10.1111/anae.14143.
PubMed 29313907
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Provocation After Nurse-Directed Assessment (PANDA) Study
- ClinicalTrials.gov ID
- NCT07127835
- Acronym / sponsor ID
- PANDAS / PANDAstudy
- Conditions
- Drug Allergy, Penicillin Allergy
- Keywords
- Nurse-led Service, Drug Provocation Test, Delabelling
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 440 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2029 (estimated)
- First posted
- 17 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nurse-led group | – | Diagnostic Test: Nurse-led penicillin allergy delabelling serviceReceive Nurse-led penicillin allergy delabelling service |
| Allergist-led group | – | Diagnostic Test: Allergist-led penicillin allergy delabelling serviceReceive Allergist-led penicillin allergy delabelling service |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nurse-led penicillin allergy delabelling servicePatients 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 test | Nurse-led group |
| Allergist-led penicillin allergy delabelling servicePatients assigned to this group will undergo risk assessment and delabeling led by allergists for both low-risk and high-risk cases. | Diagnostic test | Allergist-led group |
Primary outcome
Delabelling Success Rate
Time frame: 6 months
Assess the proportion of low-risk patients who are no longer considered allergic to penicillin after delabeling.
5 secondary outcomes
Health-Related Quality of Life
Time frame: 6 months
Antibiotic Usage Rate
Time frame: 6 months
Age Group Analysis
Time frame: 6 months
Immunocompetence Status
Time frame: 6 months
Initial vs. Recurrent Labeling
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Background: PubMed 19252115Schnyder B, Pichler WJ. Mechanisms of drug-induced allergy. Mayo Clin Proc. 2009 Mar;84(3):268-72. doi: 10.4065/84.3.268.
- Background: PubMed 29712672Abrams EM, Khan DA. Diagnosing and managing drug allergy. CMAJ. 2018 Apr 30;190(17):E532-E538. doi: 10.1503/cmaj.171315. No abstract available.
- Background: PubMed 9002492Classen DC, Pestotnik SL, Evans RS, Lloyd JF, Burke JP. Adverse drug events in hospitalized patients. Excess length of stay, extra costs, and attributable mortality. JAMA. 1997 Jan 22-29;277(4):301-6.
- Background: PubMed 19075990Pourpak Z, Fazlollahi MR, Fattahi F. Understanding adverse drug reactions and drug allergies: principles, diagnosis and treatment aspects. Recent Pat Inflamm Allergy Drug Discov. 2008 Jan;2(1):24-46. doi: 10.2174/187221308783399289.
- Background: PubMed 29313907Patton K, Borshoff DC. Adverse drug reactions. Anaesthesia. 2018 Jan;73 Suppl 1:76-84. doi: 10.1111/anae.14143.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Drug Allergy and Penicillin Allergy, run by The University of Hong Kong at 4 sites in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elaine Lee (852 9440 3349, le446@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Delabelling Success Rate (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07127835, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.