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Multiple Drug Hypersensitivity Syndrome (MDH)

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ClinicalTrials.gov Identifier: NCT03784482
Recruitment Status : Recruiting
First Posted : December 24, 2018
Last Update Posted : April 18, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier

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.


Condition or disease
Drug Allergy

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Multiple Drug Hypersensitivity Syndrome in a Large Database
Actual Study Start Date : December 20, 2018
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : July 31, 2019





Primary Outcome Measures :
  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 Outcome Measures :
  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 )



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03784482


Contacts
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Contact: Anca CHIRIAC, MD, PhD 467336107 ext 33 a-chiriac@chu-montpellier.fr
Contact: Quentin LANDRY, Medical resident quentin.landry.69@gmail.com

Locations
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France
University hospital of Montpellier Recruiting
Montpellier, France, 34295
Contact: Pascal DEMOLY, MD, phD    +33 467336107    pascal.demoly@inserm.fr   
Contact: Anca CHIRIAC, MD, phD    46733610 ext 33    ancamirelachiriac@gmail.com   
Sponsors and Collaborators
University Hospital, Montpellier
Investigators
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Principal Investigator: Pascal DEMOLY, MD, PhD University Hospital, Montpellier

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Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT03784482     History of Changes
Other Study ID Numbers: RECHMPL18_0478
First Posted: December 24, 2018    Key Record Dates
Last Update Posted: April 18, 2019
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Montpellier:
Multiple Drug Hypersensitivity
drug hypersensitivity
antibiotics
drug provocation tests
skin tests
Additional relevant MeSH terms:
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Drug Hypersensitivity Syndrome
Hypersensitivity
Drug Hypersensitivity
Immune System Diseases
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Drug Eruptions
Dermatitis
Skin Diseases