Drug Provocation Test (DPT) to Paracetamol

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03771118

Acronym

Paracetamol

Enrollment

498

Registered

2018-12-10

Start date

2018-12-01

Completion date

2019-12-30

Last updated

2026-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Drug Hypersensitivity

Keywords

Drug Hypersensitivity Reaction, Drug Provocation Test, Paracetamol, Reactive Doses, Reactive Times, Acetaminophen

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).

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

France

Contacts

PRINCIPAL_INVESTIGATORPascal DEMOLY, MD, PhD

University Hospital, Montpellier

Outcome results