Allergic Versus Non Allergic Hypersensitivity Drug Reaction (BdDAllergo) (BdDAllergo)

Etude de Cohorte Des Patients Suivis en Allergologie au CHU de Grenoble : hypersensibilité Allergique et hypersensibilité Non Allergique

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.

Study Overview

• Status: Terminated
• Conditions: Allergic Hypersensitivity Drug Reaction Versus Non-allergic Hypersensitivity Drug Reaction Cross 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.

• Study Type: Observational
• Enrollment (Actual): 456

Contacts and Locations

Study Locations

• France
  • Grenoble, France, 38043
    • UniversityHospitalGrenoble

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients who realize a complete immunoallergologic tests investigations at the University Hospital of Grenoble.

Description

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".

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
hypersensitivity drug reaction; Patient followed in the allergology department for the realization of immunoallergological test after suspicion of hypersensitivity drug reaction.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	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	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
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

Collaborators and Investigators

• Sponsor: University Hospital, Grenoble
• Investigators: Principal Investigator: Nassima YAHIAOUI, UniversityHospital Grenoble

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 29, 2017
• Primary Completion (Actual): August 1, 2018
• Study Completion (Actual): August 1, 2018

Study Registration Dates

• First Submitted: August 18, 2017
• First Submitted That Met QC Criteria: December 5, 2017
• First Posted (Actual): December 12, 2017

Study Record Updates

• Last Update Posted (Actual): February 6, 2019
• Last Update Submitted That Met QC Criteria: February 4, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: Drug hypersensitivity, drug allergy, cross reaction
• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Immune System Diseases; Hypersensitivity; Drug-Related Side Effects and Adverse Reactions
• Other Study ID Numbers: 38RC17.038; 2017-A00378-45 (Other Identifier: ID RCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No