Clincosm LogoSign in Get a demo

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

Sponsor
University Hospital, Montpellier (Other)
Overall Status
Completed
CT.gov ID
NCT03743220
Collaborator
(none)
311
Enrollment
1
Location
12.9
Actual Duration (Months)
24
Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    311 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Construction and Validation of a Simplified Provocation Tests for the Diagnosis of Non Steroidal Anti-inflammatory Drugs (NSAID) Hypersensitivity
    Actual Study Start Date :
    Dec 1, 2018
    Actual Primary Completion Date :
    Dec 30, 2019
    Actual Study Completion Date :
    Dec 30, 2019

    Outcome Measures

    Primary Outcome Measures

    1. Detect eliciting dose thresholds during NSAIDs DPT optimal step doses [1 day]

      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

    Secondary Outcome Measures

    1. Describe subgroups at higher risk during the DPT [1 day]

      Identifying the independent variables (predictive factors), using the multivariate linear regression method, that remains significantly associated with a positive NSAIDs DPT

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion criteria:
    • Patients with one or more positives DPT to NSAIDs
    Exclusion criteria:
    • Patients refusing to take part in the study

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University hospital of Montpellier Montpellier France 34295

    Sponsors and Collaborators

    • University Hospital, Montpellier

    Investigators

    • Principal Investigator: Pascal DEMOLY, MD, PhD, University Hospital, Montpellier

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Montpellier
    ClinicalTrials.gov Identifier:
    NCT03743220
    Other Study ID Numbers:
    • RECHMPL18_0433
    First Posted:
    Nov 16, 2018
    Last Update Posted:
    Mar 10, 2020
    Last Verified:
    Mar 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University Hospital, Montpellier
    Drug Hypersensitivity Reaction
    Drug Provocation Test
    Non steroidal Anti Inflammatory drugs
    Reactive Doses
    Reactive Times
    Additional relevant MeSH terms:
    Hypersensitivity
    Drug Hypersensitivity

    Study Results

    No Results Posted as of Mar 10, 2020