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Completed

NCT Number: NCT03771118

Drug Provocation Test (DPT) to Paracetamol

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).

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Key information

Conditions

Drug Hypersensitivity Chemically-Induced Disorders Drug-Related Side Effects and Adverse Reactions

Sex eligibility

All sexes

Study type

Observational

Primary location

University hospital of Montpellier

Montpellier, 34295, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study title

Construction and Validation of a Simplified Provocation Test for the Diagnosis of Paracetamol Hypersensitivity

Acronym: Paracetamol

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Dec 10, 2018
Registry last updated
Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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