An interventional study of Detailed penicillin allergy evaluation in Penicillin Allergy and Surgical Prophylaxis, sponsored by Chinese University of Hong Kong. Status unknown at 1 site in Hong Kong. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-04-21.
Sponsored by Chinese University of Hong Kong · Not applicable, Interventional, and Treatment
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.
1,916 studies on the registry are indexed under Hypersensitivity; 265 are open to participants now.
This study's planned enrollment of 68 is above the median of 57 across 1,384 interventional studies indexed under Hypersensitivity.
Browse Hypersensitivity studies →Chinese University of Hong Kong is the lead sponsor of 1,419 studies on the registry; 487 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Procedure: Detailed penicillin allergy evaluation
This group will receive standard perioperative care. The choice of antibiotics during the perioperative period will be decided by surgical team.
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.
Use of first-line antibiotic
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
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.
Time frame: 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.
Time frame: 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).
Time frame: from the date of randomization up to 3 months
Length of stay
Length of hospital stay in this episode
Time frame: 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
Time frame: form the date of randomization up to hospital discharge and from the date of randomization up to 3 months
This study is status unknown, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Chinese University of Hong Kong