Allergic Hypersensitivity Drug Reaction Versus Non-allergic Hypersensitivity Drug Reaction Cross Reaction Clinical Trial
— BdDAllergoOfficial title:
Etude de Cohorte Des Patients Suivis en Allergologie au CHU de Grenoble : hypersensibilité Allergique et hypersensibilité Non Allergique
| Verified date | February 2019 |
| Source | University Hospital, Grenoble |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Terminated |
| Enrollment | 456 |
| Est. completion date | August 1, 2018 |
| Est. primary completion date | August 1, 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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". |
| Country | Name | City | State |
|---|---|---|---|
| France | UniversityHospitalGrenoble | Grenoble |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Grenoble |
France,
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. — View Citation
Nosbaum A, Pralong P, Rozieres A, Dargaud Y, Nicolas JF, Bérard 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. Review. — View Citation
Ponvert C, Scheinmann P. [Allergic and pseudo-allergic reactions to betalactam antibiotics]. Arch Pediatr. 2003 Jul;10(7):658-65. Review. French. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Allergic Versus Non Allergic Hypersensitivity Drug Reaction | Conclusion of the immunoallergologic tests investigations : allergic hypersensitivity drug reaction case are diagnosed when the skin tests are positive or the skin tests are negative but the oral rechallenge test is positive. 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 | |
| Secondary | - 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 | |
| Secondary | immediate allergic hypersensitivity and delayed allergic hypersensitivity on clinical, biological and chronological aspects | Conclusion of the immunoallergologic tests investigations : immediate allergic hypersensitivity drug reaction case are diagnosed when the skin tests are positive at 20 minutes for Prick tests or IDR or the skin tests are negative but the oral rechallenge test is positive immediately. delayed allergic hypersensitivity drug reaction case are diagnosed when the skin tests are positive at 24 or 48 hours for IDR or the skin tests are negative but the oral rechallenge test is positive in the days following the reintroduction of treatment. |
Through study completion, an average of 5 years | |
| Secondary | 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 | |
| Secondary | - 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 |