Clinical trial NCT03743220: Drug Provocation Test (DPT) to Non Steroidal Anti-inflammatory Drugs (NSAID)
Official title: Construction and Validation of a Simplified Provocation Tests for the Diagnosis of Non Steroidal Anti-inflammatory Drugs (NSAID) Hypersensitivity
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Drug Hypersensitivity
Keywords: Drug Hypersensitivity Reaction
Drug Provocation Test
Non steroidal Anti Inflammatory drugs
Reactive Doses
Reactive Times
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2018-11-16
Enrollment: 311
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient consulting in our allergy unit for a suspicion of drug hypersensitivity to non steroidal anti inflammatory drug (s) and who underwent DPT.

Brief summary: 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).

Detailed description: DHRs to NSAIDs may be induced by both specific immunological mechanisms and mechanisms not based on immunological recognition (cross-hypersensitivity reactions \[CRs\]) .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. Although the overall prevalence of NSAID hypersensitivity has been reported between 0.6 and 7% of the general population .

The NSAIDs-induced hypersensitivity reactions involve different mechanisms and present a wide range of clinical manifestations from anaphylaxis or severe bronchospasm developing within minutes after drug ingestion to non-immediate responses appearing after days and weeks This data-driven approach in designing the DPT protocol is the second step in improving DPT standardization, after BL antibiotics.

Eligibility criteria: Inclusion criteria:

- Patients with one or more positives DPT to NSAIDs

Exclusion criteria:

- Patients refusing to take part in the study

Primary outcomes:
measure: Detect eliciting dose thresholds during NSAIDs DPT optimal step doses
timeFrame: 1 day
Secondary outcomes:
measure: Describe subgroups at higher risk during the DPT
timeFrame: 1 day
Other outcomes:
Locations:
city: Montpellier
country: France
facility: University hospital of Montpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Pascal DEMOLY, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: