Multiple Drug Hypersensitivity Syndrome (MDH)

Multiple Drug Hypersensitivity Syndrome in a Large Database

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.

Study Overview

• Status: Completed
• Conditions: Drug Allergy

• Study Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34295
    • University Hospital of Montpellier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patient consulting in our allergy unit for a suspicion of drug hypersensitivity and who underwent diagnostic drug allergy testing

Description

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).

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To measure retrospectively the frequency of MDH patients in our database.	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)	1 day
To measure retrospectively the frequency of MDH patients in our database	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	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To describe the MDH population, identify the most frequent associations of DHR	In this MDH patients population we will : Count the number of female and male patient according to their sex (No unit)	1 day
To describe the MDH population, identify the most frequent associations of DHR	In this MDH patients population we will : Most frequent associations of DHR (No unit)	1 day
To describe the MDH population, identify the most frequent associations of DHR	In this MDH patients population we will : Count and classify the different form of DHR according to their severity with the Ring and Messsmer and Regiscar study group scoring. (No unit) (ex: number of patient with grade III anaphylaxis or number of patient with DRESS syndrome )	1 day

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Investigators: Principal Investigator: Pascal DEMOLY, MD, PhD, University Hospital, Montpellier

Study record dates

Study Major Dates

• Study Start (Actual): December 20, 2018
• Primary Completion (Actual): June 30, 2019
• Study Completion (Actual): July 31, 2019

Study Registration Dates

• First Submitted: December 10, 2018
• First Submitted That Met QC Criteria: December 20, 2018
• First Posted (Actual): December 24, 2018

Study Record Updates

• Last Update Posted (Actual): November 19, 2019
• Last Update Submitted That Met QC Criteria: November 18, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: antibiotics; skin tests; Multiple Drug Hypersensitivity; drug hypersensitivity; drug provocation tests
• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Skin Diseases; Immune System Diseases; Dermatitis; Drug-Related Side Effects and Adverse Reactions; Drug Eruptions; Hypersensitivity; Drug Hypersensitivity; Drug Hypersensitivity Syndrome
• Other Study ID Numbers: RECHMPL18_0478

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No