Multiple Drug Hypersensitivity Syndrome

Completed

• Conditions: Drug Allergy

• Registration Number: NCT03784482
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-12-10
• Study Start: 2018-12-20
• Study First Submitted QC: 2018-12-20
• Study First Posted: 2018-12-24
• Primary Completion: 2019-06-30
• Study Completion: 2019-07-31
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-18
• Last Update Posted: 2019-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
To describe the MDH population, identify the most frequent associations of DHR	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 )

Trial Locations

Locations (1)

University hospital of Montpellier; 🇫🇷 Montpellier, France