Cephalosporin Hypersensitivity

NCT04421638 | Completed

• 1 other identifier: RECHMPL20_0021
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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).

Conditions

Drug Hypersensitivity

Keywords

Drug Hypersensitivity Reaction; Drug Provocation Test; Cephalosporins; Betalactams; Risk Factor

Outcome Measures

Primary Outcomes (1)

• Identify clinical variables associated with allergy to cephalosporins

  Identify clinical variables associated with allergy to cephalosporins

  1 day

Secondary Outcomes (2)

• Determine the risk variables associated with allergy to cephalosporins

  1 day

• To calculate the negative predictive value of cephalosporin DTP

  1 years

Eligibility Criteria

• Age: 10 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient consulting in our allergy unit for a suspicion of DHR to cephalosporins and who underwent a drug allergy work-up.

You may qualify if:

• \- Patients with one or more ST and DPT tests to cephalosporins

You may not qualify if:

• \- Patients refusing to take part in the study

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

Uhmontpellier

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Drug Hypersensitivity

Condition Hierarchy (Ancestors)

Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders

Study Officials

• Anca Chiriac, MD,PhD

  University Hospital, Montpellier

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2020
• First Posted: June 9, 2020
• Study Start: January 30, 2020
• Primary Completion: May 1, 2020
• Study Completion: June 1, 2020
• Last Updated: June 9, 2020

Record last verified: 2020-04

Locations

FR (1)