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Impact of Pre-operative Penicillin Allergy Evaluation on Surgical Prophylaxis

Primary Purpose

Penicillin Allergy, Surgical Prophylaxis

Status
Recruiting
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Detailed penicillin allergy evaluation
Sponsored by
Chinese University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Penicillin Allergy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: age 18 years or above planned for clean or clean-contaminated elective surgeries labelled allergy to penicillin group antibiotics on electronic patient record (ePR) Exclusion Criteria: multiple antibiotic allergy history of severe cutaneous adverse reactions or other severe non-IgE-mediated hypersensitivity (e.g. haemolytic anaemia, organ dysfunction, serum sickness) due to beta-lactam antibiotics on systemic immunosuppressants pregnancy active or uncontrolled chronic urticaria mentally incompetent for informed consent

Sites / Locations

  • Prince of Wales HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Detailed penicillin allergy evaluation during pre-operative care

Standard pre-operative care

Arm Description

This group will undergo a detailed penicillin allergy evaluation performed by an Infectious Diseases specialist. Patients with negative result in skin test and oral provocation test will have their prior labelled penicillin allergy removed from electronic health record, and an additional entry documenting the negative allergy evaluation will be added. A letter signed by an infectious disease specialist documenting the allergy evaluation results will also be given to patients.

This group will receive standard perioperative care. The choice of antibiotics during the perioperative period will be decided by surgical team.

Outcomes

Primary Outcome Measures

Use of first-line antibiotic
The primary endpoint is use of first-line antibiotic for surgical prophylaxis according to local guideline .

Secondary Outcome Measures

Antibiotic related adverse events
Antibiotic related adverse events include: 1) any new symptoms reported by patients, or 2) abnormalities in blood tests that are compatible with known side effects of antibiotics given and that occurred after initiation of antibiotics.
Surgical site infection
SSI is defined as an infection that occurs within 30 days after surgery in the part of the body where the surgery took place.
Colonization of multi-drug resistant organisms
Multi-drug resistant organisms include methicillin resistant Staphylococcus aureus (MRSA), extended spectrum beta-lactamase (ESBL) producing Enterobacterales, carbapenem resistant Enterobacterales (CRE), multi-drug resistant Acinetobacter species (MDRA), multi-drug resistant Pseudomonas aeruginosa (MRPA), and vancomycin resistant Enterococci (VRE).
Length of stay
Length of hospital stay in this episode
All-cause mortality during hospital stay
All-cause mortality during hospital stay and within 3 months

Full Information

First Posted
August 11, 2022
Last Updated
April 19, 2023
Sponsor
Chinese University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT05823155
Brief Title
Impact of Pre-operative Penicillin Allergy Evaluation on Surgical Prophylaxis
Official Title
Impact of Pre-operative Penicillin Allergy Evaluation on Surgical Prophylaxis: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2023 (Actual)
Primary Completion Date
May 31, 2024 (Anticipated)
Study Completion Date
May 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Use of first-line pre-operative antibiotic prophylaxis is the most effective measure to optimize perioperative outcomes. However, this is often not achieved due to unsubstantiated penicillin allergy labels. Penicillin allergy evaluation, when incorporated into routine pre-operative assessment, is potentially effective in optimizing choice of surgical prophylaxis. Despite the encouraging data mentioned above, there is a lack of randomized trials or local data to support this practice.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Penicillin Allergy, Surgical Prophylaxis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
68 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Detailed penicillin allergy evaluation during pre-operative care
Arm Type
Experimental
Arm Description
This group will undergo a detailed penicillin allergy evaluation performed by an Infectious Diseases specialist. Patients with negative result in skin test and oral provocation test will have their prior labelled penicillin allergy removed from electronic health record, and an additional entry documenting the negative allergy evaluation will be added. A letter signed by an infectious disease specialist documenting the allergy evaluation results will also be given to patients.
Arm Title
Standard pre-operative care
Arm Type
No Intervention
Arm Description
This group will receive standard perioperative care. The choice of antibiotics during the perioperative period will be decided by surgical team.
Intervention Type
Procedure
Intervention Name(s)
Detailed penicillin allergy evaluation
Intervention Description
The intervention group will undergo a detailed penicillin allergy evaluation performed by an Infectious Diseases specialist. Components of penicillin allergy evaluation include verification of allergy history (drug involved including dose and route of administration, exact manifestation of labelled allergy and timing of occurrence after use of alleged culprit, history of skin tests or in vitro testing for diagnosis of allergy, subsequent rechallenge of the same or similar antibiotics), followed by skin test (prick test and intradermal test) and oral provocation test as appropriate.
Primary Outcome Measure Information:
Title
Use of first-line antibiotic
Description
The primary endpoint is use of first-line antibiotic for surgical prophylaxis according to local guideline .
Time Frame
from the date of randomization up to 3 months
Secondary Outcome Measure Information:
Title
Antibiotic related adverse events
Description
Antibiotic related adverse events include: 1) any new symptoms reported by patients, or 2) abnormalities in blood tests that are compatible with known side effects of antibiotics given and that occurred after initiation of antibiotics.
Time Frame
from the date of randomization up to 3 months
Title
Surgical site infection
Description
SSI is defined as an infection that occurs within 30 days after surgery in the part of the body where the surgery took place.
Time Frame
from the date of randomization up to 30 days
Title
Colonization of multi-drug resistant organisms
Description
Multi-drug resistant organisms include methicillin resistant Staphylococcus aureus (MRSA), extended spectrum beta-lactamase (ESBL) producing Enterobacterales, carbapenem resistant Enterobacterales (CRE), multi-drug resistant Acinetobacter species (MDRA), multi-drug resistant Pseudomonas aeruginosa (MRPA), and vancomycin resistant Enterococci (VRE).
Time Frame
from the date of randomization up to 3 months
Title
Length of stay
Description
Length of hospital stay in this episode
Time Frame
from the date of hospital admission up to hospital discharge or one year whichever earlier
Title
All-cause mortality during hospital stay
Description
All-cause mortality during hospital stay and within 3 months
Time Frame
form the date of randomization up to hospital discharge and from the date of randomization up to 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: age 18 years or above planned for clean or clean-contaminated elective surgeries labelled allergy to penicillin group antibiotics on electronic patient record (ePR) Exclusion Criteria: multiple antibiotic allergy history of severe cutaneous adverse reactions or other severe non-IgE-mediated hypersensitivity (e.g. haemolytic anaemia, organ dysfunction, serum sickness) due to beta-lactam antibiotics on systemic immunosuppressants pregnancy active or uncontrolled chronic urticaria mentally incompetent for informed consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Catherine Cheung
Phone
+852 350503376
Email
catherinecheung@cuhk.edu.hk
First Name & Middle Initial & Last Name or Official Title & Degree
Grace Lui
Phone
+852 3505 1716
Email
gracelui@cuhk.edu.hk
Facility Information:
Facility Name
Prince of Wales Hospital
City
Shatin
Country
Hong Kong
Individual Site Status
Recruiting

12. IPD Sharing Statement

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Impact of Pre-operative Penicillin Allergy Evaluation on Surgical Prophylaxis

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