Drug Provocation Test (DPT) to Paracetamol (Paracetamol)
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|ClinicalTrials.gov Identifier: NCT03771118|
Recruitment Status : Recruiting
First Posted : December 10, 2018
Last Update Posted : April 18, 2019
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|
|Study Type :||Observational|
|Estimated Enrollment :||498 participants|
|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 :||June 1, 2019|
|Estimated Study Completion Date :||June 30, 2019|
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03771118
|Contact: Anca CHIRIAC, MD, PhD||467336107 ext email@example.com|
|University hospital of Montpellier||Recruiting|
|Montpellier, France, 34295|
|Contact: Pascal DEMOLY, MD, phD +33 467336107 firstname.lastname@example.org|
|Contact: Anca CHIRIAC, MD, phD 46733610 ext 33 email@example.com|
|Principal Investigator:||Pascal DEMOLY, MD, PhD||University Hospital, Montpellier|