Drug Provocation Test (DPT) to Non Steroidal Anti-inflammatory Drugs (NSAID)

NCT03743220 | Completed

• 1 other identifier: RECHMPL18_0433
• Study Type: observational
• Target: 311
• Locations: 1 country
• Sites: 1

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).

Conditions

Drug Hypersensitivity

Keywords

Drug Hypersensitivity Reaction; Drug Provocation Test; Non steroidal Anti Inflammatory drugs; Reactive Doses; Reactive Times

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Describe subgroups at higher risk during the DPT

  1 day

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• \- Patients with one or more positives DPT to NSAIDs

You may not qualify if:

• \- Patients refusing to take part in the study

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

University hospital of Montpellier

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Drug Hypersensitivity

Condition Hierarchy (Ancestors)

Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders

Study Officials

• Pascal DEMOLY, MD, PhD

  University Hospital, Montpellier

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2018
• First Posted: November 16, 2018
• Study Start: December 1, 2018
• Primary Completion: December 30, 2019
• Study Completion: December 30, 2019
• Last Updated: March 10, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)