Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03743220
Recruitment Status : Recruiting
First Posted : November 16, 2018
Last Update Posted : April 19, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier

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
Drug Hypersensitivity

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.


Layout table for study information
Study Type : Observational
Estimated 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 : December 1, 2018
Estimated Primary Completion Date : June 1, 2019
Estimated Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Detect eliciting dose thresholds during NSAIDs DPT optimal step doses [ Time Frame: 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 [ Time Frame: 1 day ]
    Identifying the independent variables (predictive factors), using the multivariate linear regression method, that remains significantly associated with a positive NSAIDs DPT



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion criteria:

- Patients with one or more positives DPT to NSAIDs

Exclusion criteria:

- Patients refusing to take part in the study


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03743220


Contacts
Layout table for location contacts
Contact: Anca CHIRIAC, MD, PhD 467336107 ext 33 a-chiriac@chu-montpellier.fr

Locations
Layout table for location information
France
University hospital of Montpellier Recruiting
Montpellier, France, 34295
Contact: Pascal DEMOLY, MD, phD    +33 467336107    pascal.demoly@inserm.fr   
Contact: Anca CHIRIAC, MD, phD    46733610 ext 33    ancamirelachiriac@gmail.com   
Sponsors and Collaborators
University Hospital, Montpellier
Investigators
Layout table for investigator information
Principal Investigator: Pascal DEMOLY, MD, PhD University Hospital, Montpellier

Layout table for additonal information
Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT03743220     History of Changes
Other Study ID Numbers: RECHMPL18_0433
First Posted: November 16, 2018    Key Record Dates
Last Update Posted: April 19, 2019
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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:
Layout table for MeSH terms
Hypersensitivity
Drug Hypersensitivity
Immune System Diseases
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antirheumatic Agents