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 (PROPHYLAL)

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 of SSIs is difficult to obtain and is probably underestimated, as many SSIs occur after the patient has been discharged from hospital and are not taken into account. SSIs are responsible for an increase in length of stay, mortality and costs. Their prevention is therefore essential in the operating theater, and has been the subject of recommendations recently updated by the CDC. The first line of prevention is the administration of prophylaxis antibiotic adapted to the surgical procedure, administered within a specific timeframe in order to achieve an effective bactericidal concentration in the tissues at the time of the surgical incision. In France, in the United States and for the WHO, the recommended first line of antibiotic prophylaxis is most often an agent from the beta-lactam family, a penicillin or a cephalosporin, with the exception of ophthalmological surgery. No strategy is described for the management of patients with a reported allergy to penicillin, apart from the recommendation of therapeutic alternatives.

The use of a decision-making strategy in the operating theater for patients with a reported allergy to penicillin therefore appears necessary and is recommended by experts. In the intraoperative context, the application of a strategy would make it possible to guide the use of cephalosporins, without removing the "penicillin allergy" label from the patient, but by proposing an alternative via the use of a cephalosporin depending on the probability of the risk of a real allergy to penicillin, according to the description of the former reaction.

Study Overview

• Status: Recruiting
• 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
• Intervention / Treatment: Other: decision tree for the choice of intraoperative antibiotic prophylaxis

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 of SSIs is difficult to obtain and is probably underestimated, as many SSIs occur after the patient has been discharged from hospital and are not taken into account. SSIs are responsible for an increase in length of stay, mortality and costs. Their prevention is therefore essential in the operating theater, and has been the subject of recommendations recently updated by the CDC. The first line of prevention is the administration of prophylaxis antibiotic adapted to the surgical procedure, administered within a specific timeframe in order to achieve an effective bactericidal concentration in the tissues at the time of the surgical incision. In France, in the United States and for the WHO, the recommended first line of antibiotic prophylaxis is most often an agent from the beta-lactam family, a penicillin or a cephalosporin, with the exception of ophthalmological surgery. No strategy is described for the management of patients with a reported allergy to penicillin, apart from the recommendation of therapeutic alternatives.

The use of a decision-making strategy in the operating theater for patients with a reported allergy to penicillin therefore appears necessary and is recommended by experts. In the intraoperative context, the application of a strategy would make it possible to guide the use of cephalosporins, without removing the "penicillin allergy" label from the patient, but by proposing an alternative via the use of a cephalosporin depending on the probability of the risk of a real allergy to penicillin, according to the description of the former reaction.

The main objective is to assess the impact on first and second generation cephalosporins prescription rate of a decision tree designed to guide the prescription of first and second generation cephalosporins in patients with a self-reported allergy to penicillin.

• Study Type: Interventional
• Enrollment (Estimated): 288
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Aurelie Gouel Cheron; Phone Number: 33 140258355; Email: aurelie.gouel@aphp.fr
• Study Contact Backup: Name: Philippe Montravers; Phone Number: 33 140258355; Email: philippe.montravers@aphp.fr

Study Locations

• France
  • Paris, France
    • Recruiting
    • Bichat Hospital
    • Contact: Mouna Ben Rehouma; Phone Number: 33 1 40 25 80 00; Email: mouna.ben-rehouma@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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 Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: usual care
Experimental: use of a decision tree to guide antibiotic prophylaxis prescription	Other: decision tree for the choice of intraoperative antibiotic prophylaxis; Presentation of a decision tree to anaesthetists to guide the choice of intraoperative antibiotic prophylaxis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
prescription of 1st generation cephalosporins	Rate of prescription of 1st cephalosporins for intraoperative antibiotic prophylaxis.	surgery day
prescription of 2nd generation cephalosporins	Rate of prescription of 2nd generation cephalosporins for intraoperative antibiotic prophylaxis.	surgery day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
surgical site infections (SSI)	number of surgical site infections (SSI)	30 days after surgery
new surgery due to surgical site infections (SSI)	number of new surgery due to SSI	30 days after surgery
intraoperative hypersensitivity reactions attributable to antibiotic prophylaxis	Number of intraoperative hypersensitivity reactions attributable to antibiotic prophylaxis	surgery day

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Mouna Ben Rehouma, Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Actual): October 9, 2023
• Primary Completion (Estimated): September 30, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: September 28, 2023
• First Submitted That Met QC Criteria: October 4, 2023
• First Posted (Actual): October 5, 2023

Study Record Updates

• Last Update Posted (Actual): December 28, 2023
• Last Update Submitted That Met QC Criteria: December 21, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Immune System Diseases; Drug-Related Side Effects and Adverse Reactions; Hypersensitivity; Drug Hypersensitivity; Anti-Infective Agents; Anti-Bacterial Agents
• Other Study ID Numbers: APHP220837

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No