Multiple Drug Hypersensitivity Syndrome

Multiple Drug Hypersensitivity Syndrome in a Large Database

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03784482

Acronym

MDH

Enrollment

Registered

2018-12-24

Start date

2018-12-20

Completion date

2019-07-31

Last updated

2019-11-19

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

Conditions

Drug Allergy

Keywords

Multiple Drug Hypersensitivity, drug hypersensitivity, antibiotics, drug provocation tests, skin tests

Brief summary

Background: Multiple drug hypersensitivity syndrome (MDH) is defined as confirmed drug hypersensitivity reactions (DHRs) to at least 2 chemically and pharmacologically unrelated drugs. Reports of MDH are scarce and poorly specified and studies which diagnose MDH on the basis of positive allergy tests are lacking. Objective: To evaluate retrospectively the frequency and characteristics of MDH patients in a large database. Methods: All the patients who consulted and were tested in our Allergy Unit between September 1996 and February 2018, with confirmed MDH will be included. Clinical history and allergy work-up results will be extracted from our Drug Allergy and Hypersensitivity Database (DAHD). The frequency of MDH will be calculated, MDH patients will be described, the most frequent associations of DHRs will be identified and analysed.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

* Patients who consulted at our allergy clinic (University Hospital of Montpellier, France) * Between September 1996 and February 2018 with a clinical history suggestive of DHR * Who completed a tailored drug allergy work-up, (including a drug allergy questionnaire, skin tests (STs) and drug provocation tests (DPTs)) and were diagnosed with MDH.

Exclusion criteria

* the DHR was due to a single component contained in 2 different drug formulations * in composed drugs; * there was possible cross-reactivity between the responsible drugs; (iv) the patient had positive but non standardized nor validated (i.e. possibly irritant) * these STs were followed by a negative DPT; * DPTs with placebo were positive; (vii) doubtful tests were repeated and eventually considered negative; * a single DHR was associated with one or more non-drug related contact allergies; * DPTs elicited subjective manifestations (i.e., isolated pruritus, headache, isolated abdominal pain); * non-specific histamine release was suspected (e.g., chronic spontaneous - desensitization, rather than a diagnostic work-up was preferred in order to meet the urgent therapeutic needs of individual patients (HIV infected patients, cardiac patients).

Design outcomes

Primary

Measure	Time frame	Description
To measure retrospectively the frequency of MDH patients in our database.	1 day	The frequency of MDH patients (percentage) in the allergic group of patients will be calculated as the number of MDH patients divided by the number of monoallergic patients (frequency of MDH patients in allergic population)
To measure retrospectively the frequency of MDH patients in our database	1 day	The frequency of MDH in common population will be calculated by will be calculated as the number of MDH patients divided by the number of patients that underwent diagnostic drug allergy testing within the same time frame (frequency of MDH patients in the whole population

Secondary

Measure	Time frame	Description
To describe the MDH population, identify the most frequent associations of DHR	1 day	In this MDH patients population we will : Count the number of female and male patient according to their sex (No unit)

Countries

France

Outcome results