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Allergic ReactionCEFAZOPENCT05605795

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

An observational study of Allergic Reaction and Beta Lactam Adverse Reaction, run by Fondation Hôpital Saint-Joseph at 1 site in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
How many people
84 participants
Where
1 siteFrance
Study dates
28 Oct 2022to 31 Dec 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

France1 site

  • Groupe Hospitalier Paris Saint-Joseph

    Paris, 75014

Other trials in France

About this study

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.

Read more

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.

Medical subject headings
Hypersensitivity

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of patients with cross-allergies between Cefazolin and Amoxicillin

    This outcome corresponds to the cross-allergy rate.

    Measured: Month1

Secondary outcomes (2)

  1. Diagnostic value of cefazolin skin tests

    This outcome corresponds to the sensitivity, specificity and predictive values of skin tests compared to oral challenge test.

    Measured: Month1

  2. 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.

    Measured: Month 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Nov 2022
  2. Study start28 Oct 2022
  3. Primary completion28 Nov 2022
  4. Study completion31 Dec 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
84 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05605795
Sponsor's protocol ID
CEFAZOPE
Acronym
CEFAZOPE
Status last verified
Mar 2023
First submitted
31 Oct 2022
Last updated
7 Mar 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Blumenthal KG, Ryan EE, Li Y, Lee H, Kuhlen JL, Shenoy ES. The Impact of a Reported Penicillin Allergy on Surgical Site Infection Risk. Clin Infect Dis. 2018 Jan 18;66(3):329-336. doi: 10.1093/cid/cix794.

    PubMed 29361015

  • Tacquard C, Collange O, Gomis P, Malinovsky JM, Petitpain N, Demoly P, Nicoll S, Mertes PM. Anaesthetic hypersensitivity reactions in France between 2011 and 2012: the 10th GERAP epidemiologic survey. Acta Anaesthesiol Scand. 2017 Mar;61(3):290-299. doi: 10.1111/aas.12855.

    PubMed 28164269

  • Blanca M, Torres MJ, Garcia JJ, Romano A, Mayorga C, de Ramon E, Vega JM, Miranda A, Juarez C. Natural evolution of skin test sensitivity in patients allergic to beta-lactam antibiotics. J Allergy Clin Immunol. 1999 May;103(5 Pt 1):918-24. doi: 10.1016/s0091-6749(99)70439-2.

    PubMed 10329829

  • Vorobeichik L, Weber EA, Tarshis J. Misconceptions Surrounding Penicillin Allergy: Implications for Anesthesiologists. Anesth Analg. 2018 Sep;127(3):642-649. doi: 10.1213/ANE.0000000000003419.

    PubMed 29757781

  • Bratzler DW, Dellinger EP, Olsen KM, Perl TM, Auwaerter PG, Bolon MK, Fish DN, Napolitano LM, Sawyer RG, Slain D, Steinberg JP, Weinstein RA; American Society of Health-System Pharmacists (ASHP); Infectious Diseases Society of America (IDSA); Surgical Infection Society (SIS); Society for Healthcare Epidemiology of America (SHEA). Clinical practice guidelines for antimicrobial prophylaxis in surgery. Surg Infect (Larchmt). 2013 Feb;14(1):73-156. doi: 10.1089/sur.2013.9999. Epub 2013 Mar 5. No abstract available.

    PubMed 23461695

  • Pool C, Kass J, Spivack J, Nahumi N, Khan M, Babus L, Teng MS, Genden EM, Miles BA. Increased Surgical Site Infection Rates following Clindamycin Use in Head and Neck Free Tissue Transfer. Otolaryngol Head Neck Surg. 2016 Feb;154(2):272-8. doi: 10.1177/0194599815617129. Epub 2015 Nov 16.

    PubMed 26573570

Questions about this trial

What is this clinical trial studying?

An observational study of Allergic Reaction and Beta Lactam Adverse Reaction, run by Fondation Hôpital Saint-Joseph at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 7 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of patients with cross-allergies between Cefazolin and Amoxicillin (time frame: Month1). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05605795, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2023.

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