An observational study in Allergic Reaction and Beta Lactam Adverse Reaction, sponsored by Fondation Hôpital Saint-Joseph. Status unknown at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-03-07.
Sponsored by Fondation Hôpital Saint-Joseph · Observational
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.
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.
1,916 studies on the registry are indexed under Hypersensitivity; 265 are open to participants now.
This study's enrollment of 84 is below the median of 115 across 479 observational studies indexed under Hypersensitivity.
Browse Hypersensitivity studies →Fondation Hôpital Saint-Joseph is the lead sponsor of 335 studies on the registry; 48 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Proportion of patients with cross-allergies between Cefazolin and Amoxicillin
This outcome corresponds to the cross-allergy rate.
Time frame: Month1
Diagnostic value of cefazolin skin tests
This outcome corresponds to the sensitivity, specificity and predictive values of skin tests compared to oral challenge test.
Time frame: Month1
Description of the safety of our protocol for the reintroduction of cefazolin and amoxicillin in the context of IgE-mediated cross-allergy
This outcome corresponds to the number of anaphylaxis\> grade I triggered on alternative challenge test.
Time frame: Month 1
This study is status unknown, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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Fondation Hôpital Saint-Joseph