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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-A00378-45 | Other Identifier | ID RCB |
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departure of the investigator from the CHU Grenoble Alpes
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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 :
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| hypersensitivity drug reaction | Patient followed in the allergology department for the realization of immunoallergological test after suspicion of hypersensitivity drug reaction. |
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| Measure | Description | Time Frame |
|---|---|---|
| Allergic Versus Non Allergic Hypersensitivity Drug Reaction | Conclusion of the immunoallergologic tests investigations :
| Through study completion, an average of 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| - To determine the proportion of drugs involved in in allergic hypersensitivity drug reaction for each pharmacotherapeutic class | Immunoallergologic tests investigations that conclude to an allergic hypersensitivity drug reaction | Through study completion, an average of 5 years |
| immediate allergic hypersensitivity and delayed allergic hypersensitivity on clinical, biological and chronological aspects |
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Inclusion Criteria:
Exclusion Criteria:
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All patients who realize a complete immunoallergologic tests investigations at the University Hospital of Grenoble.
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| Name | Affiliation | Role |
|---|---|---|
| Nassima YAHIAOUI | UniversityHospital Grenoble | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UniversityHospitalGrenoble | Grenoble | 38043 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12746667 | Result | 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. | |
| 12907084 | Result | 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. |
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| ID | Term |
|---|---|
| D004342 | Drug Hypersensitivity |
| ID | Term |
|---|---|
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| D064419 | Chemically-Induced Disorders |
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Conclusion of the immunoallergologic tests investigations :
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| Through study completion, an average of 5 years |
| To determine the proportion of drugs that potentially induced histamine-liberation in patients diagnosed with non allergic hypersensitivity drug reaction for each pharmacotherapeutic class | Conclusion of the immunoallergologic tests investigations : - non allergic hypersensitivity drug reaction case are diagnosed when the skin tests are negative AND the oral rechallenge test is negative. | Through study completion, an average of 5 years |
| - Proportion of cross-reaction between drugs belonging to the same pharmacotherapeutic class in patients diagnosed with allergic hypersensitivity drug reaction. | Conclusion of the immunoallergologic tests investigations : - Cross-reaction are diagnosed when the immunoallergologic test investigation is positive for medicinal products belonging to the same pharmacotherapeutic class as the responsible treatment of the skin reaction. | ancillary study, Through study completion, an average of 5 years |
| 22578340 | Result | 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. |