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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)

Primary Purpose

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

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
decision tree for the choice of intraoperative antibiotic prophylaxis
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Adult Patients Who Declare an Allergy to Penicillin During Anaesthetic Consultation Without Any Allergy Work up That Could Confirm This Declaration

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    usual care

    use of a decision tree to guide antibiotic prophylaxis prescription

    Arm Description

    Outcomes

    Primary Outcome Measures

    prescription of 1st generation cephalosporins
    Rate of prescription of 1st cephalosporins for intraoperative antibiotic prophylaxis.
    prescription of 2nd generation cephalosporins
    Rate of prescription of 2nd generation cephalosporins for intraoperative antibiotic prophylaxis.

    Secondary Outcome Measures

    surgical site infections (SSI)
    number of surgical site infections (SSI)
    new surgery due to surgical site infections (SSI)
    number of new surgery due to SSI
    intraoperative hypersensitivity reactions attributable to antibiotic prophylaxis
    Number of intraoperative hypersensitivity reactions attributable to antibiotic prophylaxis

    Full Information

    First Posted
    September 28, 2023
    Last Updated
    October 4, 2023
    Sponsor
    Assistance Publique - Hôpitaux de Paris
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06067919
    Brief Title
    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
    Acronym
    PROPHYLAL
    Official Title
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 9, 2023 (Anticipated)
    Primary Completion Date
    September 30, 2024 (Anticipated)
    Study Completion Date
    December 31, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Assistance Publique - Hôpitaux de Paris

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    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

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Sequential Assignment
    Model Description
    assess the impact of disseminating of a decision tree on prescribing practices, a cluster randomised, stepped-wedge, multicentre, national, interventional, pragmatic and open study will be carried out.
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    288 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    usual care
    Arm Type
    No Intervention
    Arm Title
    use of a decision tree to guide antibiotic prophylaxis prescription
    Arm Type
    Experimental
    Intervention Type
    Other
    Intervention Name(s)
    decision tree for the choice of intraoperative antibiotic prophylaxis
    Intervention Description
    Presentation of a decision tree to anaesthetists to guide the choice of intraoperative antibiotic prophylaxis
    Primary Outcome Measure Information:
    Title
    prescription of 1st generation cephalosporins
    Description
    Rate of prescription of 1st cephalosporins for intraoperative antibiotic prophylaxis.
    Time Frame
    surgery day
    Title
    prescription of 2nd generation cephalosporins
    Description
    Rate of prescription of 2nd generation cephalosporins for intraoperative antibiotic prophylaxis.
    Time Frame
    surgery day
    Secondary Outcome Measure Information:
    Title
    surgical site infections (SSI)
    Description
    number of surgical site infections (SSI)
    Time Frame
    30 days after surgery
    Title
    new surgery due to surgical site infections (SSI)
    Description
    number of new surgery due to SSI
    Time Frame
    30 days after surgery
    Title
    intraoperative hypersensitivity reactions attributable to antibiotic prophylaxis
    Description
    Number of intraoperative hypersensitivity reactions attributable to antibiotic prophylaxis
    Time Frame
    surgery day

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Aurelie Gouel Cheron
    Phone
    140258355
    Ext
    33
    Email
    aurelie.gouel@aphp.fr
    First Name & Middle Initial & Last Name or Official Title & Degree
    Philippe Montravers
    Phone
    140258355
    Ext
    33
    Email
    philippe.montravers@aphp.fr

    12. IPD Sharing Statement

    Learn more about this trial

    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

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