Drug Hypersensitivity Clinical Trial
— NSAIDOfficial title:
Construction and Validation of a Simplified Provocation Tests for the Diagnosis of Non Steroidal Anti-inflammatory Drugs (NSAID) Hypersensitivity
Verified date | March 2020 |
Source | University Hospital, Montpellier |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Background : Non steroidal anti-inflammatory drugs are responsible for 25% of reported
adverse drug events which include immunological and non-immunological hypersensitivity
reactions. NSAIDs have been reported to be the second most common cause of drug-induced
hypersensitivity reaction (DHR). They are almost mandatory in a human life and therefore, the
drug allergy work-up goes up until a DPT in order to confirm or rule out the diagnosis.
Objective: Detect eliciting dose thresholds during NSAIDs DPT in order to suggest optimal
step doses and to describe subgroups at higher risk during the DPT
Methods:This retrospective study, using the survival analysis, comprised all patients who
attended the allergy service of the UH of Montpellier from 1997 till 2017 with a clinical
history related to NSAIDs DHR, who underwent NDAIDs DPT that turned positive and who gave
their consent to be included in the study . The Patients are selected from the Drug Allergy &
Hypersensitivity Database (DAHD).
Status | Completed |
Enrollment | 311 |
Est. completion date | December 30, 2019 |
Est. primary completion date | December 30, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
Inclusion criteria: - Patients with one or more positives DPT to NSAIDs Exclusion criteria: - Patients refusing to take part in the study |
Country | Name | City | State |
---|---|---|---|
France | University hospital of Montpellier | Montpellier |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Montpellier |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Detect eliciting dose thresholds during NSAIDs DPT optimal step doses | The DPT was considered positive if objective signs occurred during NSAIDs administration. The reactive dose (RD) was calculated from the total cumulative dose (mg) reached when the DPT was considered positive | 1 day | |
Secondary | Describe subgroups at higher risk during the DPT | Identifying the independent variables (predictive factors), using the multivariate linear regression method, that remains significantly associated with a positive NSAIDs DPT | 1 day |
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