Status:
COMPLETED
Multiple Drug Hypersensitivity Syndrome
Lead Sponsor:
University Hospital, Montpellier
Conditions:
Drug Allergy
Eligibility:
All Genders
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 ...
Eligibility Criteria
Inclusion
- 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).
Exclusion
Key Trial Info
Start Date :
December 20 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 31 2019
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT03784482
Start Date
December 20 2018
End Date
July 31 2019
Last Update
November 19 2019
Active Locations (1)
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1
University hospital of Montpellier
Montpellier, France, 34295