Drug Hypersensitivity Clinical Trial
— CephALLOfficial title:
Drug Hypersensitivity Reactions To Cephalosporins
| Verified date | April 2020 |
| Source | University Hospital, Montpellier |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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).
| Status | Completed |
| Enrollment | 500 |
| Est. completion date | June 1, 2020 |
| Est. primary completion date | May 1, 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 10 Years and older |
| Eligibility |
Inclusion criteria: - Patients with one or more ST and DPT tests to cephalosporins Exclusion criteria: - Patients refusing to take part in the study |
| Country | Name | City | State |
|---|---|---|---|
| France | Uhmontpellier | Montpellier |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Montpellier |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Identify clinical variables associated with allergy to cephalosporins | Identify clinical variables associated with allergy to cephalosporins | 1 day | |
| Secondary | Determine the risk variables associated with allergy to cephalosporins | Determine the risk variables associated with allergy to cephalosporins | 1 day | |
| Secondary | To calculate the negative predictive value of cephalosporin DTP | 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. | 1 years |
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