Impact of Pre-operative Penicillin Allergy Evaluation on Surgical Prophylaxis

Penicillin Allergy Clinical Trial

Official title:

Impact of Pre-operative Penicillin Allergy Evaluation on Surgical Prophylaxis: a Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05823155
• Other study ID #: Penicillin allergy Protocol V1
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2023
• Est. completion date: May 31, 2024

Study information

• Verified date: April 2023
• Source: Chinese University of Hong Kong
• Contact: Catherine Cheung
• Phone: +852 350503376
• Email: catherinecheung[@]cuhk.edu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 68
• Est. completion date: May 31, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Drug Hypersensitivity
• Hypersensitivity
• Penicillin Allergy

Intervention

Procedure:
• Detailed penicillin allergy evaluation
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.

Locations

Country	Name	City	State
Hong Kong	Prince of Wales Hospital	Shatin

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Use of first-line antibiotic	The primary endpoint is use of first-line antibiotic for surgical prophylaxis according to local guideline .	from the date of randomization up to 3 months
Secondary	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.	from the date of randomization up to 3 months
Secondary	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.	from the date of randomization up to 30 days
Secondary	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).	from the date of randomization up to 3 months
Secondary	Length of stay	Length of hospital stay in this episode	from the date of hospital admission up to hospital discharge or one year whichever earlier
Secondary	All-cause mortality during hospital stay	All-cause mortality during hospital stay and within 3 months	form the date of randomization up to hospital discharge and from the date of randomization up to 3 months