NCT07127835

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
440

participants targeted

Target at P75+ for all trials

Timeline
41mo left

Started Sep 2025

Longer than P75 for all trials

Geographic Reach
1 country

4 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress17%
Sep 2025Aug 2029

First Submitted

Initial submission to the registry

August 10, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 17, 2025

Completed
15 days until next milestone

Study Start

First participant enrolled

September 1, 2025

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2027

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2029

Last Updated

April 29, 2026

Status Verified

August 1, 2025

Enrollment Period

2 years

First QC Date

August 10, 2025

Last Update Submit

April 28, 2026

Conditions

Keywords

Nurse-led ServiceDrug Provocation TestDelabelling

Outcome Measures

Primary Outcomes (1)

  • Delabelling Success Rate

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

    6 months

Secondary Outcomes (5)

  • Health-Related Quality of Life

    6 months

  • Antibiotic Usage Rate

    6 months

  • Age Group Analysis

    6 months

  • Immunocompetence Status

    6 months

  • Initial vs. Recurrent Labeling

    6 months

Study Arms (2)

Nurse-led group

Receive Nurse-led penicillin allergy delabelling service

Diagnostic Test: Nurse-led penicillin allergy delabelling service

Allergist-led group

Receive Allergist-led penicillin allergy delabelling service

Diagnostic Test: Allergist-led penicillin allergy delabelling service

Interventions

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.

Nurse-led group

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

Allergist-led group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Prince of Wales Hospital

Hong Kong, 999077, Hong Kong

RECRUITING

Princess Margaret Hospital

Hong Kong, 999077, Hong Kong

RECRUITING

Queen Elizabeth Hospital

Hong Kong, 999077, Hong Kong

RECRUITING

Queen Mary Hospital

Hong Kong, 999077, Hong Kong

RECRUITING

Related Publications (5)

  • Schnyder B, Pichler WJ. Mechanisms of drug-induced allergy. Mayo Clin Proc. 2009 Mar;84(3):268-72. doi: 10.4065/84.3.268.

    PMID: 19252115BACKGROUND
  • Abrams EM, Khan DA. Diagnosing and managing drug allergy. CMAJ. 2018 Apr 30;190(17):E532-E538. doi: 10.1503/cmaj.171315. No abstract available.

    PMID: 29712672BACKGROUND
  • Classen 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.

    PMID: 9002492BACKGROUND
  • Pourpak 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.

    PMID: 19075990BACKGROUND
  • Patton K, Borshoff DC. Adverse drug reactions. Anaesthesia. 2018 Jan;73 Suppl 1:76-84. doi: 10.1111/anae.14143.

    PMID: 29313907BACKGROUND

MeSH Terms

Conditions

Drug Hypersensitivity

Condition Hierarchy (Ancestors)

Drug-Related Side Effects and Adverse ReactionsChemically-Induced Disorders

Central Study Contacts

Elaine Lee

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

August 10, 2025

First Posted

August 17, 2025

Study Start

September 1, 2025

Primary Completion (Estimated)

August 31, 2027

Study Completion (Estimated)

August 31, 2029

Last Updated

April 29, 2026

Record last verified: 2025-08

Locations