Drug Provocation Test (DPT) to Paracetamol

Completed

• Conditions: Drug Hypersensitivity

• Registration Number: NCT03771118
• Lead Sponsor: 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-11-13
• Study Start: 2018-12-01
• Study First Submitted QC: 2018-12-07
• Study First Posted: 2018-12-10
• Primary Completion: 2019-12-01
• Study Completion: 2019-12-30
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-09
• Last Update Posted: 2020-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 498

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Detect of the reactive dose (RD)	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

Name	Time	Method
Measure is a positive DPT to paracetamol	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.

Trial Locations

Locations (1)

University hospital of Montpellier; 🇫🇷 Montpellier, France