Clinical trial NCT03369509: Allergic Versus Non Allergic Hypersensitivity Drug Reaction (BdDAllergo)
Official title: Etude de Cohorte Des Patients Suivis en Allergologie au CHU de Grenoble : hypersensibilité Allergique et hypersensibilité Non Allergique
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Allergic Hypersensitivity Drug Reaction Versus Non-allergic Hypersensitivity Drug Reaction Cross Reaction
Keywords: Drug hypersensitivity, drug allergy, cross reaction
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2017-12-12
Enrollment: 456
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients who realize a complete immunoallergologic tests investigations at the University Hospital of Grenoble.

Brief summary: The creation of a database containing the medical data of patients followed in allergology at the University Hospital of Grenoble will permit to study allergic versus non-allergic hypersensitivity drug reaction as well as the risk of cross-reactions between medicinal drugs belonging to the same pharmacological class.

The main objectives of the study are to estimate and to compare the proportion of allergic hypersensitivity drug reaction and the proportion of non allergic hypersensitivity drug reaction, and to characterize these two types of hypersensitivity drug reaction on clinical, biological and chronological aspects.

In a second time, ancillary study will be conducted in order to :

* identify drugs that potentially induced histamine-liberation in patients diagnosed with non allergic hypersensitivity drug reaction
* investigate the risk of cross-reactions between drugs belonging to the same pharmacotherapeutic class in patients diagnosed with allergic hypersensitivity drug reaction.

Detailed description: This study is an observational cohort study conducted at University Hospital of Grenoble. It include retrospectively and prospectively the patients followed in the allergology department for the realization of immunoallergological test after suspicion of hypersensitivity drug reaction. The data are collected in a database from medical consultation reports that are systematically reported to the pharmacovigilance regional center. An anonymization number is assigned for each patient included in the study.The data collected include patient's personal and family medical history, a clinical, biological and chronological description of the hypersensitivity reaction, the results of the immunoallergologic skin tests as well as the final diagnosis.

Eligibility criteria: Inclusion Criteria:

* Cases where a non-iatrogenic cause was finally identified

Exclusion Criteria:

* For the estimation and comparison of the proportions, the patients who haven't carried out all their immunoallergologic tests investigations at the University Hospital of Grenoble are not included (this concerns patient who have realized only oral rechallenge test at hospital)
* To realize the comparative analysis of allergic versus non-allergic hypersensitivity drug reaction : cases that are insufficiently documented on clinical, biological and / or chronological aspects are excluded. This concerns especially patients who realize immunoallergologic tests investigations after a skin reaction that occurred "in childhood".

Primary outcomes:
measure: Allergic Versus Non Allergic Hypersensitivity Drug Reaction
timeFrame: Through study completion, an average of 5 years
Secondary outcomes:
measure: - To determine the proportion of drugs involved in in allergic hypersensitivity drug reaction for each pharmacotherapeutic class
timeFrame: Through study completion, an average of 5 years
measure: immediate allergic hypersensitivity and delayed allergic hypersensitivity on clinical, biological and chronological aspects
timeFrame: Through study completion, an average of 5 years
measure: To determine the proportion of drugs that potentially induced histamine-liberation in patients diagnosed with non allergic hypersensitivity drug reaction for each pharmacotherapeutic class
timeFrame: Through study completion, an average of 5 years
measure: - Proportion of cross-reaction between drugs belonging to the same pharmacotherapeutic class in patients diagnosed with allergic hypersensitivity drug reaction.
timeFrame: ancillary study, Through study completion, an average of 5 years
Other outcomes:
Locations:
city: Grenoble
country: France
facility: UniversityHospitalGrenoble
Study officials:
affiliation: UniversityHospital Grenoble
name: Nassima YAHIAOUI
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cousin F, Catelain A, Philips K, Favier B, Queuille E, Nicolas JF. [Immediate hypersensitivity is rarely implicated in drug induced urticaria]. Ann Dermatol Venereol. 2003 Mar;130(3):321-4. French.
citation: Ponvert C, Scheinmann P. [Allergic and pseudo-allergic reactions to betalactam antibiotics]. Arch Pediatr. 2003 Jul;10(7):658-65. doi: 10.1016/s0929-693x(03)00272-0. No abstract available. French.
citation: Nosbaum A, Pralong P, Rozieres A, Dargaud Y, Nicolas JF, Berard F. [Delayed-type hypersensitivity to heparin: diagnosis and therapeutic management]. Ann Dermatol Venereol. 2012 May;139(5):363-8. doi: 10.1016/j.annder.2012.01.017. Epub 2012 Mar 9. French.