Penicillin AllergyNCT05823155
Impact of Pre-operative Penicillin Allergy Evaluation on Surgical Prophylaxis
A study testing Detailed penicillin allergy evaluation in people with Penicillin Allergy and Surgical Prophylaxis, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Penicillin Allergy, Surgical Prophylaxis
- What is being tested?
- Detailed penicillin allergy evaluation
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Apr 2023to 31 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
Who may be able to join
- age 18 years or above
- planned for clean or clean-contaminated elective surgeries
- labelled allergy to penicillin group antibiotics on electronic patient record (ePR)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Pre-operative Penicillin Allergy Evaluation on Surgical Prophylaxis: a Randomized Controlled Trial
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.
- Conditions
- Penicillin Allergy, Surgical Prophylaxis
- Being tested
- Detailed penicillin allergy evaluation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Detailed penicillin allergy evaluationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Detailed penicillin allergy evaluation during pre-operative care | Experimental | 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. Receives: Procedure: Detailed penicillin allergy evaluation |
| Standard pre-operative care | No intervention | This group will receive standard perioperative care. The choice of antibiotics during the perioperative period will be decided by surgical team. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Use of first-line antibiotic
The primary endpoint is use of first-line antibiotic for surgical prophylaxis according to local guideline .
Measured: from the date of randomization up to 3 months
Secondary outcomes (5)
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.
Measured: from the date of randomization up to 3 months
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.
Measured: from the date of randomization up to 30 days
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).
Measured: from the date of randomization up to 3 months
Length of stay
Length of hospital stay in this episode
Measured: from the date of hospital admission up to hospital discharge or one year whichever earlier
All-cause mortality during hospital stay
All-cause mortality during hospital stay and within 3 months
Measured: form the date of randomization up to hospital discharge and from the date of randomization up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2023
- Study start1 Apr 2023
- Primary completion31 May 2024 (estimated)
- Study completion31 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Penicillin AllergyStudies of the same condition, open and under way.
- More trials run by Chinese 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Grace Lui, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05823155
- Sponsor's protocol ID
- Penicillin allergy Protocol V1
- Status last verified
- Apr 2023
- First submitted
- 11 Aug 2022
- Last updated
- 21 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Pre-operative Penicillin Allergy Evaluation on Surgical Prophylaxis: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05823155
- Acronym / sponsor ID
- Penicillin allergy Protocol V1
- Conditions
- Penicillin Allergy, Surgical Prophylaxis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 31 May 2024 (estimated)
- Study completion
- 31 May 2024 (estimated)
- First posted
- 21 Apr 2023 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Detailed penicillin allergy evaluation during pre-operative care | Experimental | Procedure: Detailed penicillin allergy evaluationThis 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. |
| Standard pre-operative care | No intervention | –This group will receive standard perioperative care. The choice of antibiotics during the perioperative period will be decided by surgical team. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age 18 years or above
- planned for clean or clean-contaminated elective surgeries
- labelled allergy to penicillin group antibiotics on electronic patient record (ePR)
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| Detailed penicillin allergy evaluationThe 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. | Procedure or surgery | Detailed penicillin allergy evaluation during pre-operative care |
Primary outcome
Use of first-line antibiotic
Time frame: from the date of randomization up to 3 months
The primary endpoint is use of first-line antibiotic for surgical prophylaxis according to local guideline .
5 secondary outcomes
Antibiotic related adverse events
Time frame: from the date of randomization up to 3 months
Surgical site infection
Time frame: from the date of randomization up to 30 days
Colonization of multi-drug resistant organisms
Time frame: from the date of randomization up to 3 months
Length of stay
Time frame: from the date of hospital admission up to hospital discharge or one year whichever earlier
All-cause mortality during hospital stay
Time frame: form the date of randomization up to hospital discharge and from the date of randomization up to 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2023.
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Detailed penicillin allergy evaluation in people with Penicillin Allergy and Surgical Prophylaxis, run by Chinese University of Hong Kong at 1 site 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 3 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 21 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Catherine Cheung (+852 350503376, catherinecheung@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Use of first-line antibiotic (time frame: from the date of randomization up to 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Apr 2023.