Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 5 of 63 for:    Recruiting, Not yet recruiting, Available Studies | Drug allergy

Drug Provocation Test (DPT) to Paracetamol (Paracetamol)

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: NCT03771118
Recruitment Status : Recruiting
First Posted : December 10, 2018
Last Update Posted : August 9, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier

Brief Summary:

Background : Paracetamol (acetaminophen) drug hypersensitivity reactions (DHR) are oonfirmed in about 10% of alleged cases. The diagnosis is made via an empirical drug provocation test (DPT).

Objective: Detect eliciting dose thresholds during Paracetamol DPT in order to suggest optimal step doses and to identify variables and potential risk factors associated with Paracetamol hypersensitivity.

Methods:This retrospective study, using the survival analysis and the multivariate analysis, will comprise all patients who attended the allergy service of the University Hospital of Montpellier from 1996 till 2018 with a clinical history related to Paracetamol DHR, who underwent Paracetamol DPT 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

Layout table for study information
Study Type : Observational
Estimated Enrollment : 498 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Construction and Validation of a Simplified Provocation Test for the Diagnosis of Paracetamol Hypersensitivity
Actual Study Start Date : December 1, 2018
Estimated Primary Completion Date : December 1, 2019
Estimated Study Completion Date : December 30, 2019

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Detect of the reactive dose (RD) [ Time Frame: 1 day ]
    The outcome measure of the RD : The dose that the patient reaches when the DPT is positive, divided by the total DPT dose for a given patient. This RD will be calculated for every patient with a positive DPT. New events (positive DPT) from one RD to another will be evaluated in number and severity.


Secondary Outcome Measures :
  1. Measure is a positive DPT to paracetamol [ Time Frame: 1 day ]

    Identifying clinical risk factors (Odds Ratio), using the binary logistic regression method, significantly associated with a positive Paracetamol DPT.

    Age at reaction, sex, presence of asthma and atopy, type and chronology of the initial reaction will be evaluated as potential risk factors. Risk factors of anaphylaxis during DPT will also be calculated, using the same variables.

    Potential variables to explain this measure will be introduced in a logistic model, in order to obtain crude and adjusted OR that could explain a positive DPT to paracetamol.




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 Paracetamol and who underwent DPT.
Criteria

Inclusion criteria:

- Patients with a positive or negative DPT to paracetamol

Exclusion criteria:

  • Patients refusing to take part in the study
  • Patient under 10 years old

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): NCT03771118


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: NCT03771118     History of Changes
Other Study ID Numbers: RECHMPL18_0434
First Posted: December 10, 2018    Key Record Dates
Last Update Posted: August 9, 2019
Last Verified: August 2019
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
Paracetamol
Reactive Doses
Reactive Times
Acetaminophen
Additional relevant MeSH terms:
Layout table for MeSH terms
Hypersensitivity
Drug Hypersensitivity
Drug-Related Side Effects and Adverse Reactions
Immune System Diseases
Chemically-Induced Disorders
Acetaminophen
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics