Multiple Drug Hypersensitivity Syndrome (MDH)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03784482|
Recruitment Status : Recruiting
First Posted : December 24, 2018
Last Update Posted : April 18, 2019
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|
|Study Type :||Observational|
|Estimated Enrollment :||50 participants|
|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|
- 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)
- 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
- 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)
- 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)
- 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 )
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
|Contact: Anca CHIRIAC, MD, PhD||467336107 ext email@example.com|
|Contact: Quentin LANDRY, Medical firstname.lastname@example.org|
|University hospital of Montpellier||Recruiting|
|Montpellier, France, 34295|
|Contact: Pascal DEMOLY, MD, phD +33 467336107 email@example.com|
|Contact: Anca CHIRIAC, MD, phD 46733610 ext 33 firstname.lastname@example.org|
|Principal Investigator:||Pascal DEMOLY, MD, PhD||University Hospital, Montpellier|