Multiple Drug Hypersensitivity Syndrome

NCT03784482 | Completed

• 1 other identifier: RECHMPL18_0478
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Drug Allergy

Keywords

Multiple Drug Hypersensitivity; drug hypersensitivity; antibiotics; drug provocation tests; skin tests

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

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

  1 day

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

  1 day

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

  1 day

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

University hospital of Montpellier

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Drug Hypersensitivity

Condition Hierarchy (Ancestors)

Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders

Study Officials

• Pascal DEMOLY, MD, PhD

  University Hospital, Montpellier

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2018
• First Posted: December 24, 2018
• Study Start: December 20, 2018
• Primary Completion: June 30, 2019
• Study Completion: July 31, 2019
• Last Updated: November 19, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)