Investigation of Cross-allergies Between Cefazolin and Amoxicillin With Skin Tests and Provocation Test (CEFAZOPE)

March 6, 2023 updated by: Groupe Hospitalier Paris Saint Joseph

Antibiotic prophylaxis in the operating room reduces the frequency of occurrence of surgical site infections (SSI) by preventing bacterial proliferation.

The main antibiotic used in all surgery is CEFAZOLINE. This antibiotic of the Beta-lactam family, and more precisely of the 1st generation cephalosporins, is active on a specific bacterial target, which is often the cause of surgical site infections. Patients known to be allergic to penicillin have a 50% higher risk of surgical site infection. The choice of antibiotic prophylaxis often comes up against the risk of allergy in anesthesia. In France in 2004, according to the INSERM database, 100 IgE-mediated immediate hypersensitivity reactions (IHR) were observed out of 1 million anesthesias. The attributable allergens in descending order were curares (60.6%), latex (5.2%) then antibiotics (18.2%), followed by dyes (3.5%), hypnotics, opioids, gelatins and local anesthetics were rarely found. Regarding allergy to antibiotics, the leading antibiotic for allergy in France is AMOXICILLIN, which accounts for 29% of drug-induced anaphylaxis. In view of the risk of cross-allergy, a history of allergy to AMOXICILLIN in the operating room is a contraindication to all beta-lactam antibiotics and therefore leads to an alternative choice to CEFAZOLINE when the latter was indicated for first-line antibiotic prophylaxis.

However, this choice of alternative antibiotic to CEFAZOLINE is not without consequences. First of all, the alternative antibiotics Vancomycin and Clindamycin have a narrower spectrum and therefore may not cover all germs found in SSI. They do not cover Gram-negative organisms for Vancomycin and Gram-negative aerobes for Clindamycin. Moreover, the use of these antibiotics exposes to undesirable effects. They can promote the occurrence of nosocomial infections such as Clostridium difficile colitis, infections with resistant germs such as methicillin-resistant Staphylococcus aureus (MRSA) or Vancomycin-resistant Enterococcus (VRE). Other adverse effects may occur such as Nephrotoxicity and Red Man Syndrome with Vancomycin. In addition, these antibiotics may be more difficult to handle, not allowing for the optimization of recommended delivery conditions. Secondly, the notion of the cost of these antibiotics must be taken into account.

Two elements could encourage investigators to use CEFAZOLINE despite a history of allergy to AMOXICILLIN.

  1. 1. Allergy declarations such as can be obtained in consultation correspond mainly to false positives. In fact, out of 10% of the world's population reporting an allergy to penicillins, only 1 to 2% of subjects have a proven allergy. In GHPSJ, among the patients consulting for a suspected allergy, the reintroduction test confirmed it in only 5.6% of them.
  2. From a molecular point of view, there is a low rate of similarity between these two molecules. Contrary to popular belief, cephalosporin allergy is not mediated by the β-lactam core. The cross-allergy between cephalosporins and penicillin comes from the similarities of the R1 chain which is attached to the β-lactam nucleus at position 7 for cephalosporins, at position 6 for penicillins. This may therefore explain the lack of clinical cross-reactivity.

The primary objective is to evaluate the proportion of patients of allergies between CEFAZOLINE and AMOXICILLINE.

The secondary objectives are to evaluate the diagnostic value of skin tests to CEFAZOLINE and to describe the safety of protocol of reintroduction of CEFAZOLINE and AMOXICILLINE in the context of IgE-mediated cross-reactivity.

Study Overview

Status

Active, not recruiting

Conditions

Study Type

Observational

Enrollment (Actual)

84

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75014
        • Groupe Hospitalier Paris Saint-Joseph

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

  • Patient who had an allergic reaction to a beta-lactam infusion as well as the patient who developed a severe form of anaphylaxis, with proven drug allergy by skin test to a beta-lactam of the penicillin or cephalosporin type in immediate reading or rereading of prick test, intradermal reaction (IDR) or patch test.
  • Patients managed in consultation with the allergology department of GHPSJ for exploration of their drug allergy since 01/01/2019.

Description

Inclusion Criteria:

  • Patient whose age ≥ 18 years,
  • French-speaking patient
  • Patient who had an allergic reaction to a beta-lactam infusion as well as the patient who developed a severe form of anaphylaxis
  • Proven drug allergy by skin test to a beta-lactam of the penicillin or cephalosporin type in immediate reading or rereading of prick test, intradermal reaction (IDR) or patch test.
  • Patients managed in consultation with the allergology department of GHPSJ for exploration of their drug allergy since 01/01/2019.

Exclusion Criteria:

  • Patient under guardianship or curatorship
  • Patient deprived of liberty
  • Patient under court protection
  • Patient objecting to the use of his data for this research

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients with cross-allergies between Cefazolin and Amoxicillin
Time Frame: Month1
This outcome corresponds to the cross-allergy rate.
Month1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic value of cefazolin skin tests
Time Frame: Month1
This outcome corresponds to the sensitivity, specificity and predictive values of skin tests compared to oral challenge test.
Month1
Description of the safety of our protocol for the reintroduction of cefazolin and amoxicillin in the context of IgE-mediated cross-allergy
Time Frame: Month 1
This outcome corresponds to the number of anaphylaxis> grade I triggered on alternative challenge test.
Month 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Groupe Hospitalier Paris Saint Joseph

Investigators

  • Principal Investigator: Noemie GEST, MD, Groupe hospitalier Paris saint Joseph

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 28, 2022

Primary Completion (Actual)

November 28, 2022

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

October 31, 2022

First Submitted That Met QC Criteria

October 31, 2022

First Posted (Actual)

November 4, 2022

Study Record Updates

Last Update Posted (Estimate)

March 7, 2023

Last Update Submitted That Met QC Criteria

March 6, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEFAZOPE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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