Cephalosporin Hypersensitivity

Completed

• Conditions: Drug Hypersensitivity

• Registration Number: NCT04421638
• Lead Sponsor: University Hospital, Montpellier

Brief Summary

Background :

Although the hypersensitivity reactions to cephalosporins have been recently a more focused subject, studies on the cephalosporin as an allergen are significantly less frequent that those regarding penicillins. Most of the available data regards cephalosporin sensitization in patients previously allergic to penicillin. Like penicillins, cephalosporins represent one of the most prescribed classes of antibiotics. The diagnosis of cephalosporin hypersensitivity is based mainly on clinical history, skin tests (ST) and drug provocation tests (DPT). This succession of tests, performed in specialized services, allows to eliminate responsibility for the drug in many cases (80-85%). The drug allergy work-up also allows to identify profiles of allergy to cephalosporins, with different patterns of cross-reactivity.

Objective: To analyse the characteristics of patients studied in our Unit for suspicion of cephalosporin hypersensitivity.

Methods: This retrospective study will comprise all the patients who attended the allergy service of the UH of Montpellier from 1997 till 2018 with a clinical history evocative of cephalosporin drug hypersensitivity reaction (DHR), who underwent a drug allergy work up and who gave their consent to be included in the study . The Patients are selected from the Drug Allergy \& Hypersensitivity Database (DAHD).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-01-08
• Study Start: 2020-01-30
• Status Verified: 2020-04
• Primary Completion: 2020-05-01
• Study Completion: 2020-06-01
• Study First Submitted QC: 2020-06-04
• Last Update Submitted: 2020-06-04
• Study First Posted: 2020-06-09
• Last Update Posted: 2020-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Identify clinical variables associated with allergy to cephalosporins	1 day	Identify clinical variables associated with allergy to cephalosporins

Secondary Outcome Measures

Name	Time	Method
Determine the risk variables associated with allergy to cephalosporins	1 day	Determine the risk variables associated with allergy to cephalosporins
To calculate the negative predictive value of cephalosporin DTP	1 years	In the subgroup of patients for whom we have data on readministration of a negatively tested cephalosporin following drug allergy work-up, we will calculate the negative predictive value of cephalosporin DPT.

Trial Locations

Locations (1)

Uhmontpellier; 🇫🇷 Montpellier, France