Status:
COMPLETED
Assessment of the Applicability and Acceptability of an Algorithm to Guide the Prescription of 1st and 2nd Generation Cephalosporins as Part of Intraoperative Antibiotic Prophylaxis in Patients With a Declared Allergy to Penicillin
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Adult Patients Who Declare an Allergy to Penicillin During Anaesthetic Consultation Without Any Allergy Work up That Could Confirm This Declaration
Good Comprehension of French Language
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
According to the Centers for Disease Control and Prevention (CDC), a surgical site infection (SSI) is an infection that occurs after surgery at the site where the surgery was performed. The prevalence...
Detailed Description
According to the Centers for Disease Control and Prevention (CDC), a surgical site infection (SSI) is an infection that occurs after surgery at the site where the surgery was performed. The prevalence...
Eligibility Criteria
Inclusion
- Age \>= 18 years;
- Patients with a good French understanding
- Who declare themselves allergic to penicillin and who have not benefit from an allergy work-up to explore their allergies and possible therapeutic alternatives;
- Requiring antibiotic prophylaxis with either first or second generation cephalosporins for elective or emergency surgery.
Exclusion
- Refusal to sign informed consent
- Patient under legal protection ;
- Pregnant women;
- Patient scheduled for surgery requiring first-line antibiotic prophylaxis with an agent other than first and second generation cephalosporins (such as amoxicillin/clavulanate or vancomycin) according to the recommendations of the French Society of Anaesthesia and Intensive Care (SFAR) in one of the investigating centres;
- Patient declaring an allergy to antibiotics other than penicillins.
- Not affiliated to a social security scheme
Key Trial Info
Start Date :
October 9 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 20 2025
Estimated Enrollment :
275 Patients enrolled
Trial Details
Trial ID
NCT06067919
Start Date
October 9 2023
End Date
May 20 2025
Last Update
August 24 2025
Active Locations (1)
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1
Bichat hospital
Paris, France