Cephalosporin Hypersensitivity

Drug Hypersensitivity Reactions To Cephalosporins

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04421638

Acronym

CephALL

Enrollment

500

Registered

2020-06-09

Start date

2020-01-30

Completion date

2020-06-01

Last updated

2020-06-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Drug Hypersensitivity

Keywords

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

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).

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

10 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

\- Patients refusing to take part in the study

Design outcomes

Primary

Measure	Time frame	Description
Identify clinical variables associated with allergy to cephalosporins	1 day	Identify clinical variables associated with allergy to cephalosporins

Secondary

Measure	Time frame	Description
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.

Countries

France

Outcome results