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Completed

NCT Number: NCT03784482

Multiple Drug Hypersensitivity Syndrome

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.

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Key information

Conditions

Drug Allergy Chemically-Induced Disorders Drug Hypersensitivity Drug-Related Side Effects and Adverse Reactions

Sex eligibility

All sexes

Study type

Observational

Primary location

University hospital of Montpellier

Montpellier, 34295, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Primary outcomes

  1. To measure retrospectively the frequency of MDH patients in our database.

    Time frame: 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)

  2. To measure retrospectively the frequency of MDH patients in our database

    Time frame: 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 outcomes

  1. To describe the MDH population, identify the most frequent associations of DHR

    Time frame: 1 day

    In this MDH patients population we will : Count the number of female and male patient according to their sex (No unit)

  2. To describe the MDH population, identify the most frequent associations of DHR

    Time frame: 1 day

    In this MDH patients population we will : Most frequent associations of DHR (No unit)

  3. To describe the MDH population, identify the most frequent associations of DHR

    Time frame: 1 day

    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 )

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study title

Multiple Drug Hypersensitivity Syndrome in a Large Database

Acronym: MDH

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Dec 24, 2018
Registry last updated
Nov 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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